acupuncture for shoulder pain

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Acupuncture for shoulder pain Sally Green 1 , Rachelle Buchbinder 2 , Sarah E Hetrick 3 1 Australasian Cochrane Centre, Monash University, Clayton, Australia. 2 Monash Department of Clinical Epidemiology at Cabrini Hospital, Department of Epidemiology and Preventive Medicine, Monash University, Malvern, Australia. 3 Department of Psychiatry, ORYGEN Research Centre, Melbourne, Australia Contact address: Sally Green, Australasian Cochrane Centre, Monash University, Monash Medical Centre, Locked Bag 29, Clayton, Victoria, 3168, Australia. [email protected] . (Editorial group: Cochrane Musculoskeletal Group .) Cochrane Database of Systematic Reviews, Issue 4, 2008 (Status in this issue: Edited) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DOI: 10.1002/14651858.CD005319 This version first published online: 20 April 2005 in Issue 2, 2005. Re-published online with edits: 8 October 2008 in Issue 4, 2008. Last assessed as up-to-date: 22 February 2005. (Dates and statuses? ) This record should be cited as: Green S, Buchbinder R, Hetrick SE. Acupuncture for shoulder pain. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD005319. DOI: 10.1002/14651858.CD005319. Background Conditions causing shoulder pain are common and contribute substantially to the musculoskeletal morbidity of the community (Bjelle 1989 ). The prevalence of shoulder disorders has been reported to range from seven to 36% of the general population (Lundberg 1969 ). Shoulder disorders account for 1.2% of all general practice encounters in Australia, being third only to back and neck complaints as musculoskeletal reasons for primary care consultation (Bridges-Webb 1992 ). In Dutch general practice the incidence of shoulder disorders has been estimated to be 11.2 per 1000 registered patients per year (van der Windt 1995 ). The shoulder is frequently injured, particularly in competitive sports with eight to 13% of athletic injuries involving the shoulder (Hill 1983 ). Prevalence of shoulder disorders has been shown to increase with age (Badley 1992 ). This finding has implications for the provision of

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Acupuncture for shoulder pain

Sally Green1, Rachelle Buchbinder2, Sarah E Hetrick3

1Australasian Cochrane Centre, Monash University, Clayton, Australia. 2Monash Department of Clinical Epidemiology at Cabrini Hospital, Department of Epidemiology and Preventive Medicine, Monash University, Malvern, Australia. 3Department of Psychiatry, ORYGEN Research Centre, Melbourne, Australia

Contact address: Sally Green, Australasian Cochrane Centre, Monash University, Monash Medical Centre, Locked Bag 29, Clayton, Victoria, 3168, Australia. [email protected]. (Editorial group: Cochrane Musculoskeletal Group.)

Cochrane Database of Systematic Reviews, Issue 4, 2008 (Status in this issue: Edited)Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.DOI: 10.1002/14651858.CD005319This version first published online: 20 April 2005 in Issue 2, 2005. Re-published online with edits: 8 October 2008 in Issue 4, 2008. Last assessed as up-to-date: 22 February 2005. (Dates and statuses?)

This record should be cited as: Green S, Buchbinder R, Hetrick SE. Acupuncture for shoulder pain. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD005319. DOI: 10.1002/14651858.CD005319.

 Background

Conditions causing shoulder pain are common and contribute substantially to the musculoskeletal morbidity of the community (Bjelle 1989). The prevalence of shoulder disorders has been reported to range from seven to 36% of the general population (Lundberg 1969). Shoulder disorders account for 1.2% of all general practice encounters in Australia, being third only to back and neck complaints as musculoskeletal reasons for primary care consultation (Bridges-Webb 1992). In Dutch general practice the incidence of shoulder disorders has been estimated to be 11.2 per 1000 registered patients per year (van der Windt 1995). The shoulder is frequently injured, particularly in competitive sports with eight to 13% of athletic injuries involving the shoulder (Hill 1983).

Prevalence of shoulder disorders has been shown to increase with age (Badley 1992). This finding has implications for the provision of health care in view of the aging of the population as a whole. Others however (Allander 1974; Ingemar 1993) have demonstrated a decline in both the prevalence and incidence of shoulder pain with age, the peak prevalence occurring in the 56 - 60 year age group. As this section of the community is likely to be in paid employment, such peak prevalence has impact on the direct and indirect cost of shoulder disorders to the community.

Substantial disability may result from shoulder disorders. Moving the shoulder allows placement of the hand, hence compromised shoulder mobility impacts substantially on the performance of tasks essential to daily living (e.g. dressing, personal hygiene, eating and work). In addition, shoulder pain is often associated with impaired ability to sleep, so affecting mood and concentration. People with shoulder pain scored substantially less than normal values on the SF-36 (a standardised measure of general health) for physical function, social function, physical role function, emotional role function and pain (Gartsman 1998; Beaton 1996). Shoulder disorders are often recalcitrant with some studies demonstrating persisting pain and disability from 12 months (van der Windt 1995) to 18 months (Chard 1991) in up to 50% of cases.

There are many commonly used treatments for shoulder disorders, including physiotherapy modalities, non-steroidal anti-inflammatory drugs, glucocorticosteroid injections, oral

glucocorticosteroids, manipulation under anaesthesia, hydrodilatation (distension arthrography), acupuncture and surgery. Whilst some interventions can be regarded as efficacious, overall there is limited evidence regarding the efficacy of these interventions (Green 1998). Furthermore, the interpretation of results of existing studies is often hampered by the fact that these disorders are labelled and defined in diverse and often conflicting ways (Green 1998).

This review is one in a series of reviews aiming to establish the efficacy of common interventions for shoulder pain. This series of reviews form the update of an earlier Cochrane Review of all interventions for shoulder disorders (Green 1999). Since our previous review, many new clinical trials, studying a diverse range of interventions, have been performed. In order to update our review we have subdivided it into a series of reviews investigating the evidence for efficacy of single interventions. We have also broadened our review to include all randomised or quasi-randomised clinical trials regardless of whether outcome assessment was blinded (unblinded trials were excluded from the original review).

Acupuncture to treat musculoskeletal pain is being increasingly accepted, by both clinicians and consumers of health care. Approximately one million consumers utilise acupuncture annually in the United States (Paramore 1997), and a large percentage of these suffer musculoskeletal disorders (Diehl 1997).

Acupuncture is thought to confer an analgesic effect (Batra 1985; Viola 1998). Several hypotheses for this effect have been proposed. Some authors attribute the analgesic effects to the release of b-endorphins in the lumbar spine and increased 5-Hydroxy tryptophan level in the cerebrum (Viola 1998). Other explanations include the overriding of the pain stimulus by the biochemical lines of acupuncture in the transmitting process of the central nervous system (Viola 1998), and the more traditional explanation of the freeing of a blockage of "Qi" (energy flow) or a stagnation of blood by acupuncture (Viola 1998).

Although acupuncture is sometimes used for the treatment of shoulder pain, few studies have investigated the efficacy of this intervention, and to our knowledge, no systematic review has been published specifically addressing the effectiveness of acupuncture for relief of pain and dysfunction of the shoulder. This review aims to investigate the efficacy and safety of acupuncture for shoulder pain.

Objectives

To determine the efficacy and safety of acupuncture in the treatment of people with shoulder pain and dysfunction.

Methods

Criteria for considering studies for this review Types of studies a) Randomised or quasi-randomised controlled trials regardless of publication type. Studies where participants were not randomised into intervention groups were excluded from the review.

b) Trials in which allocation to intervention or control group was not concealed from the outcome assessor were included but recorded as such in the table of included studies.

c) Studies in all languages were translated into English and considered for inclusion in the review.

Types of participants Inclusion in this review was restricted to trials with participants meeting the following criteria:

a) Adults >16 years of age.b) Shoulder pain or disorder for greater than 3 weeks, irrespective of diagnostic label (unless an

exclusion criteria). Studies that included various soft tissue disorders were considered if the results on shoulder pain were presented separately or if 90% or more of participants in the study had shoulder pain.c) Studies of participants suffering a history of significant trauma or systemic inflammatory conditions such as rheumatoid arthritis, polymyalgia rheumatica and fracture, hemiplegic shoulders, post-operative and peri-operative shoulder pain and pain in the shoulder region as part of a complex myofacial neck/shoulder/arm pain were excluded.

Trials were sub-grouped into type of shoulder disorder for analysis (see methods section).

In our previous review, we performed a methodological review of the selection criteria used in the included studies (Green 1998). Study populations were broadly able to be categorised as either adhesive capsulitis (which included frozen shoulder and periarthritis) or rotator cuff disease (which included supraspinatus tendonitis, infraspinatus tendonitis, rotator cuff tendonitis, rotator cuff lesion, bursitis or subscapularis tendonitis) based upon the diagnostic labels and/or definitions of these labels when described. Some trials did not specify a diagnosis and some trials gave no selection criteria or definition of study population (Green 1998). For this review we were broadly able to categorise the participants as adhesive capsulitis (including frozen shoulder and periarthritis), rotator cuff disease, osteoarthritis, and mixed diagnoses (including trials where a definition of study population was not specified).

Types of interventions All randomised controlled comparisons of acupuncture versus placebo, no treatment, another intervention, or of varying types and dosages of acupuncture compared to each other were included and comparisons established according to intervention.

Types of outcome measures No studies were excluded on the basis of outcome measure used. Outcomes reported in trials were pain, time to maximum pain relief, shoulder discomfort, range of motion (external and internal rotation, flexion, extension, and abduction), shoulder function, success or failure of treatment, and adverse events.

Search methods for identification of studies MEDLINE, EMBASE, CINAHL (includes all major physiotherapy and occupational therapy journals from U.S.A., Canada, England, Australia and New Zealand), and Science Citation Index (SCISEARCH) were searched from inception to December 2003 .

The following search terms were used in MEDLINE (see additional Table 1 for search strategies for other databases):

1 Shoulder Pain/2 Shoulder Impingement Syndrome/3 Rotator Cuff/4 exp Bursitis/5 ((shoulder$ or rotator cuff) adj5 (bursitis or frozen or impinge$ or tendinitis or tendonitis or pain$)).mp.6 rotator cuff.mp.7 adhesive capulitis.mp8 or/1-79 ACUPUNCTURE/10 exp Acupuncture Therapy/11 ELECTROACUPUNCTURE/12 acupuncture$.tw13 electroacupuncture$.tw.14 or/9-13

15 clinical trial.pt.16 random$.mp17 ((single or double) adj (blind$ or mask$)).mp18 placebo$.mp.19 or/15-1820 8 and 14 and 19

In addition, the Cochrane Controlled Trials Register (CCTR) Issue 4, 2003 was searched.

Data collection and analysis Following identification of potential trials for inclusion by the previously outlined search strategy, the methods sections of all identified trials were reviewed independently according to predetermined criteria (see selection criteria), by two reviewers. All articles were coded and details of source, intervention, population and funding recorded. Where the two reviewers disagreed it was planned that discussion would be facilitated in order to reach consensus, however, there were no disagreements.

Trials meeting inclusion criteria were then collated, and the methods and results sections re-sent to the same two reviewers for assessment of trial validity and data extraction.

ASSESSMENT OF VALIDITYValidity of included trials was assessed by description of whether they met key criteria (including appropriate randomisation, allocation concealment, blinding, number lost to follow up and intention to treat analysis). Trial quality was not scored numerically. The only quantitative scoring was given for allocation concealment, ranked as:A: adequateB: unclear, orC: inadequate.

Whether or not trials were appropriately randomised (as described in the Cochrane Reviewer's Handbook)(Alderson 2003); blinded participants, care providers and outcome assessor; had complete follow up and used an intention to treat analysis was recorded on a pre-piloted data extraction sheet and later transposed into the Characteristics of Included Studies table.Trial quality was assessed in this qualitative way as opposed to using a numerical or summary scale due to concerns regarding the validity of such scales and lack of information about whether all the criteria included in such scales impact on the overall outcome of the trial (Juni 1999).

DATA EXTRACTION AND ANALYSISIn order to assess efficacy, raw data for outcomes of interest (specifically means and standard deviations for continuous outcomes and number of events for binary outcomes) were extracted where available from the published reports. All standard errors of the mean were converted to standard deviation. Wherever data were converted or imputed, this was recorded in the notes section of the Characteristics of Included Studies table. For trials where the required data were not reported or able to be calculated, further details were requested from first authors. If no further details were provided, the trial was included in the review and fully described, but not included in the meta-analysis (i.e.. not included in the pooling of study data). An entry to that effect was made in the notes section of the Characteristics of Included Studies table.

When trial results were not normally distributed and so reported as median and range, the trial was not included in the meta-analysis but results presented in Additional Tables.Meta-analysis was facilitated by RevMan software. The following choices of statistic and 95% confidence intervals were presented for all outcomes:

CONTINUOUS OUTCOMES:Weighted mean difference using a fixed effect model was selected when outcomes were measured on standard scales. When like outcomes were reported on non standard scales, using differing units and

methods of assessment (for example disability scales), a standardised mean difference was selected. Possible clinical and methodological reasons for heterogeneity were explored, and in the presence of significant heterogeneity, trial results were not combined.

DICHOTOMOUS OUTCOMES:Relative risk using a fixed effects model was selected for interpretation of dichotomous outcome measures in this review as we believe that this is the most appropriate statistic for interpretation when the event is common. Reasons for heterogeneity were evaluated and in the event of significant heterogeneity trial results were not pooled.

SUBGROUP ANALYSISShoulder pain and disorder may be caused by varying underlying pathologies, and the diagnostic criteria for defining these disorders are not consistent nor reliably applied. Resulting from this, many trials investigate interventions in non-defined or mixed populations of participants, while others report a specific diagnosis, for example, rotator cuff disease or adhesive capsulitis. Trials included in this review were therefore divided into subgroups based on the description of the study population provided by the trial. Results were analysed both within diagnostic subgroups and across all disorders. This was planned a priori.

Results

Description of studies See: Characteristics of included studies; Characteristics of excluded studies.

Eighteen potentially eligible trials were identified by the search strategy. We are awaiting further information from three trialists (Batra 1985; Mencke 1988; Xu 1982) to ascertain details for inclusion or exclusion. One of these studies was published in German (Mencke), and one was published in Chinese (Xu) with the third published in English. The review will be updated once details regarding the inclusion/exclusion criteria from the remaining studies awaiting assessment have been obtained from authors ( Table 2).

Nine of the 18 trials met the inclusion criteria (Berry 1980; Ceccherelli 2001; Dyson-Hudson 2001; Kleinhenz 1999; Lin 1994; Moore 1976; Romoli 2000; Sun 2001; Yuan 1995). The reasons for exclusion of remaining six studies (D'Orta 1985; Hanson 1997; Hu 1993; Nabeta 2002; Peng 1987; Wang 1997) are listed in the Table of Excluded Studies. Details of the nine included studies are given in the Table of Included studies and are described below.

Results from six trials were published in English (Berry 1980; Ceccherelli 2001; Dyson-Hudson 2001; Kleinhenz 1999; Moore 1976; Sun 2001) and two were published in Chinese (Lin 1994; Yuan 1995). The study design of the ninth trial was published in English and results from the pilot of the trial were obtained from the author (Romoli 2000).

There was methodological and clinical diversity in the included trials. Shoulder conditions included rotator cuff syndrome (Berry 1980; Kleinhenz 1999), periarthritis (Yuan 1995), adhesive capsulitis (frozen shoulder) (Lin 1994; Sun 2001) and general or mixed shoulder pain (Ceccherelli 2001; Dyson-Hudson 2001; Romoli 2000). In one of these trials, the participants had shoulder pain as a result of wheelchair use (Dyson-Hudson 2001). One trial was in a population with periarticular disease (tendonitis or bursitis) or osteoarthritis (Moore 1976).

Three studies compared acupuncture to placebo (Berry 1980; Kleinhenz 1999; Moore 1976). Placebo methods included using placebo needles that did not penetrate the skin (Kleinhenz 1999; Moore 1976) and placebo tolmetin sodium plus placebo ultrasound (Berry 1980) .

Five trials compared acupuncture to other interventions. One of these trials included both an ultrasound group and a steroid injection group as comparisons (Berry 1980). Other comparison

interventions included nerve block (Lin 1994), mobilization alone (Romoli 2000), exercise (Sun 2001) and Trager (Dyson-Hudson 2001). Trager is a form of body work and movement re-education based on the Trager theory that puts forward the notion that the mind contributes to pain by maintaining muscles and other soft tissue in a chronically contracted and inflammatory position. Trager includes gentle movements to loosen joints and release chronic pain and a system of effortless movement sequences called mentastics exercises.

Two studies compared different types of acupuncture with comparisons made between deep and shallow acupuncture (Ceccherelli 2001) and acupuncture with sites determined by pathogenesis according to traditional Chinese medicine and the distribution of Jing-Luo (Yuan 1995).

The type of acupuncture used in each trial varied only slightly and was described as traditional or classic acupuncture (i.e. according to traditional Chinese medicine) which includes (though not always specified) reaching the point where the phenomena of soreness, numbness & heaviness are experienced. There was some variation in number of points used and in some cases electrical stimulus was added (Batra 1985). Moxibustion was used in one trial (Berry 1980). Treatments were typically of twenty to thirty minutes duration and were conducted two or three times a week for a period of three to six weeks, resulting in the course of most treatments ranging between eight and 12 sessions. Exceptions were in the trial by Moore (Moore 1976) where treatment was once a week for three weeks and in the trial by Yuan (Yuan 1995) where participants received a session every second day for a total of five treatments. The treatment procedures and regimen were not always described fully in each trial, and are summarised in the 'interventions' column of the Characteristics of Included Studies table.

Risk of bias in included studies Included studies were of varying methodological quality. A full description of each trial against the predetermined quality assessment criteria can be found in the Characteristics of Included Studies table. Trial populations were on the whole small (median sample size = 44, range 18 to 150). The smallest trial had six drop-outs and it is not stated if an intention to treat analysis was carried out. The second smallest trial (N=24) was only the pilot phase of a larger trial that is underway and the unpublished data from the pilot study was provided by the trialist (Romoli 2000). Allocation concealment was adequate in three trials (Kleinhenz 1999; Romoli 2000; Yuan 1995), unclear in five (Ceccherelli 2001; Dyson-Hudson 2001; Lin 1994; Moore 1976; Sun 2001) and inadequate in one (Berry 1980). Seven trials blinded outcome assessor (Berry 1980; Dyson-Hudson 2001; Kleinhenz 1999; Moore 1976; Romoli 2000; Sun 2001; Yuan 1995) and two blinded participants (Kleinhenz 1999; Moore 1976). There was adequate follow-up in five trials (Berry 1980; Ceccherelli 2001; Kleinhenz 1999; Moore 1976; Sun 2001).

Eight trials presented sufficient data to be included in meta-analysis. Data from the ninth trial (Moore 1976) is included in Additional Table 1.

Effects of interventions ACUPUNCTURE COMPARED TO PLACEBOTwo trials assessed success rate of acupuncture in the short term (defined as a positive rating by participants in Kleinhenz 1999 and by no need for follow-up steroid injection by assessors in Berry 1980) for rotator cuff disease. There was no significant difference between success rates in the acupuncture group compared to the placebo group (RR 1.01 (0.69 to 1.48)). Nor was there a significant difference between acupuncture and placebo in reducing pain or increasing the range of abduction in the short term (Berry 1980). One small trial did demonstrate a significant difference post intervention (4 weeks) favouring the acupuncture group for improved shoulder pain, range of movement and functioning measured by a composite score of these factors (The Constant Murley Score) (WMD 17.3 (7.79, 26.81) out of a total score of 100). At four months follow-up a significant difference remained between the groups, however the difference between the change in scores in the acupuncture group and the change in scores in the placebo group was unlikely to be clinically significant (WMD 3.53(0.74 to 6.32)) (i.e.. a change of 3.53 on a scale of 100 is unlikely to represent

a clinically significant improvement). A third trial, whose results could not be included in the meta-analysis due to insufficient data, failed to demonstrate a significant difference between acupuncture and placebo in a measure of subjective improvement post intervention (Moore 1976) ( Table 3).

Only one trial included adverse effects as an outcome (Kleinhenz 1999), finding no difference between groups with respect to the incidence of fainting, headache, dizziness, inflammatory reactions or leg weakness.

ACUPUNCTURE COMPARED TO STEROID INJECTIONOne trial compared acupuncture to anterior glenohumeral injection of corticosteroid for rotator cuff disease, with only 12 participants in each group (Berry 1980). There was no significant difference from placebo following treatment with respect to pain (WMD 7.5 (-12.47 to 27.47)), range of abduction (WMD 2.9 (-26.83 to 32.62) or success rate (RR 0.83 (0.35 to 2.00)).

ACUPUNCTURE COMPARED TO ULTRASOUNDThe same trial (Berry 1980) with 12 participants per group compared acupuncture to ultrasound and demonstrated no significant difference between groups following treatment with respect to pain (WMD -7.10 (-32.90 to 18.70)), range of abduction (WMD 7.9 (-21.59 to 37.39) or success rate (RR 0.83 (0.35 to 2.00)).

ELECTROACUPUNCTURE COMPARED TO STELLATE GANGLION BLOCK AND SUPRASCAPULAR NERVE BLOCKA trial of 100 participants with adhesive capsulitis, published in Chinese, investigated the relative effects of electroacupuncture and regional nerve block (anaesthesia of stellate ganglion and suprascapular nerve) (Lin 1994). There was a significant difference favouring nerve block over acupuncture in reducing pain at 30 hours follow-up (WMD 1.33 (1.22 to 1.44 )) (out of a total score of 4). The time to achieve maximum pain relief was significantly shorter in the nerve block group (WMD 64.96 (60.50 to 69.42 minutes)). There was a statistically significant but small difference favouring nerve block in increasing range of flexion (WMD -7.00 (-11.17 to -2.83)). No adverse effect was assessed for either intervention. This trial gives no information as to the relative effect of either intervention compared to no treatment or placebo.

ACUPUNCTURE PLUS MOBILISATION VERSUS ACUPUNCTURE ALONEIn a pilot study of participants with general shoulder pain (of no particular diagnosis) (Romoli 2000), eight in the acupuncture plus mobilization group and eight in the mobilization only group, results post intervention revealed no significant difference between the acupuncture plus mobilization compared to mobilization alone with respect to pain at rest (WMD -0.37(-1.85 to 1.11)), pain on movement (WMD 0.25 (-1.87 to 2.37)) (out of a total of 10), or active flexion (WMD -13.13(-39.79 to 13.53) and abduction (WMD -14.37 (-49.94 to 21.20)). No longer term follow-up data were provided by the trialist, nor is there information regarding the effect of either intervention compared to placebo or no treatment.

ACUPUNCTURE PLUS EXERCISE VERSUS EXERCISE ALONEA small trial comparing acupuncture and exercise with exercise alone for adhesive capsulitis (Sun 2001) showed a significant difference favouring the acupuncture plus exercise group in a composite measure of pain, range of motion and functioning post intervention (WMD 9.20 (0.54 to 17.86)) (out of a total score of 100). The effect remained at 20 weeks follow-up (WMD 9.40 (0.52 to 18.28)).

ACUPUNCTURE VERSUS TRAGAROne trial compared acupuncture and Tragar for the treatment of general shoulder pain (no particular diagnosis) due to wheel chair use (Dyson-Hudson 2001). There were no significant differences in pain scores post intervention (WMD 1.70 (-21.91 to 25.31)) or at five weeks follow-up (WMD 16.00 (-9.03 to 41.03)) (out of a total of 150) between the groups. This trial provides no information about the benefits of acupuncture or Tragar compared to placebo or no intervention.

DEEP VERSUS SHALLOW ACUPUNCTUREIn a trial comparing deep acupuncture and shallow acupuncture in those with general shoulder pain (no particular diagnosis) there was a significant difference favouring deep acupuncture over shallow acupuncture with respect to pain post intervention (WMD -10.31 (-15.44 to -5.18)) and at three months follow-up (-8.00 (-12.20 to -3.80). Pain was recorded using the Mc Gill Pain Questionnaire (Melzack 1975) (Ceccherelli 2001).

JING LUO VERSUS TRADITIONAL CHINESE MEDICINE ACUPUNCTUREThere was a significantly greater recovery rate in the group where acupuncture sites were determined according to the distribution of Jing Luo compared to sites determined according to pathogenesis in the theory of traditional Chinese medicine (RR 1.50 (1.08 to 2.09)) for periarthritis (Yuan 1995). This trial gives no information about the benefits of acupuncture compared to placebo or no treatment.

Discussion

Based on our review, no firm conclusions can be drawn regarding the efficacy of acupuncture for shoulder disorders. Nine trials of varying methodological quality, most of which were small, met the inclusion criteria. There were often incomplete descriptions of interventions, which varied between trials. There were a large number of different comparison groups, including different placebo interventions.

There were few significant findings with regard to the use of acupuncture when compared to placebo or other interventions. Due to small sample sizes it is possible that this may be explained by Type II error. Acupuncture was of benefit over placebo in improving the Constant Murley Score (a measure of shoulder function), however, by the three month follow-up, the difference between the acupuncture and placebo groups, whilst still statistically significant, was no longer likely to be clinically significant. Acupuncture used in combination with exercise was demonstrated to be more effective than exercise alone in one small trial. Deep acupuncture was shown to be more effective than shallow acupuncture and acupuncture using sites determined by Jing Luo was more effective than that using sites determined by traditional Chinese medicine, however, neither of these trials included placebo or other intervention comparison groups. In one of the larger trials, nerve block was found to be more effective than acupuncture on a range of outcome measures but no follow-up data were reported and the pain outcome measurement used may be inappropriate. Few trials reported adverse events associated with acupuncture when compared to placebo or other interventions.

This review has highlighted the paucity of methodologically rigorous, well described randomised controlled trials with adequate sample sizes assessing acupuncture for shoulder disorders. Trials lack standardised interventions, placebos and comparisons. A limited amount of pooling was possible in this review which indicates that some progress has been made with regard to the selection of standardised, valid and reliable outcome measures since our initial review in 1999. However, it is still true that the failure to apply a core set of measures to determine outcome in shoulder disorders limits the degree to which the results of different trials can be compared and/or pooled and firm conclusions regarding efficacy can be drawn.

Our analysis did differentiate between the nature of the populations being studied, however, there were few trials within each of these sub-groups and over all few conclusions could be made. This is nevertheless an important point to keep in mind when considering the efficacy of acupuncture as it may vary depending on the different underlying causes of shoulder pain. As there were a small number of trials and they were testing varying interventions in various populations against varying controls, it is difficult to interpret the evidence and draw conclusions about the value of acupuncture for these disorders.

Of particular note is that few trials measure disability associated with shoulder disorder. Disability may in fact be the most important endpoint, particularly from the patient's perspective, and we would encourage future trials to use shoulder specific disability as a primary outcome in determining effect.

Further standardisation in timing of outcome assessment is also required as is longer term follow-up of outcomes to determine any lasting effects. Some of the included trials did not blind the outcome assessor and therefore, given the measures of effect were based on the subjective outcomes of pain and treatment success, it is likely the results of the included trials may have overestimated effect (Schulz 2002).

Authors' conclusions

Implications for practiceDue to a small number of clinical and methodologically diverse trials, little can be concluded from this review. There is little evidence to either support or refute the use of acupuncture for treating shoulder pain and more trials are needed. The limited evidence available indicates some short term benefit of acupuncture compared to placebo with respect to shoulder specific disability. Little is known of the potential for adverse effects.

Implications for researchSystematic reviews and meta-analyses of randomised controlled trials serve to identify areas of clinical practice where further research is required. When sound conclusions about efficacy cannot be made after this process, there is a need for methodologically sound randomised controlled trials to justify or censure current treatment strategies.

One trial included in this review (Kleinhenz 1999) developed an appropriate placebo for use in acupuncture trials which may inform future trials.

Further trials should consider assessing the effect of acupuncture when combined with other modalities, define study population by clear diagnostic criteria, use standardised outcome measures for disability and pain, be adequately powered, follow up participants to determine longer term outcome and give consideration to adverse effect.

Acknowledgements

We are grateful to the Musculoskeletal Cochrane Review Group for their methodological support and to Steve McDonald from the Australasian Cochrane Centre for his help with the search strategy. Kristine Egberts assisted with the final editing. We are also grateful to Dr Marco Romoli who provided data from his pilot study of acupuncture for shoulder pain. We would like to thank the reviewers who contributed to the original review as follows:

Richard GlazierAssistant ProfessorUniversity of TorontoOntario, Canada

Andrew ForbesSenior Lecturer (Biostatistics)Department Epidemiology and Preventive Medicine

Monash UniversityAustralia

We are particularly grateful to Jun Min for translation/data extraction of Hu 1993 (awaiting assessment) , Yuan 1995 (included), Xu 1982 (awaiting assessment), and Wang 1997 (excluded), and to Professor Konrad Streitberger, University of Heidelberg, who clarified details of a non-English publication reporting on the results of the trial published by Julia Klienhenz.

Data and analyses

Comparison 1. ACUPUNCTURE VERSUS PLACEBO

Outcome or subgroup title

No. of studies

No. of participants

Statistical method Effect size

1 Pain Post Intervention Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   1.1 Rotator cuff disease

1 24 Mean Difference (IV, Fixed, 95% CI)

Not estimable

2 Range of abduction Post Intervention

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   2.1 Rotator cuff disease

1 24 Mean Difference (IV, Fixed, 95% CI)

Not estimable

3 Success rate (short term)

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

   3.1 Rotator cuff disease

2 76 Risk Ratio (M-H, Fixed, 95% CI)

1.01 [0.69, 1.48]

4 Overall success (Constant Murley score) at 4 weeks

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   4.1 Rotator cuff disease

1 52 Mean Difference (IV, Fixed, 95% CI)

Not estimable

5 Overall success (Constant Murley score) at 4 months

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

    5.1 Rotator cuff 1 35 Mean Difference Not

disease (IV, Fixed, 95% CI)

estimable

6 Adverse effect Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

    6.1 Fainting 1 52 Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

    6.2 Headaches 1 52 Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

    6.3 Dizziness 1 52 Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

   6.4 Inflammatory reaction

1 52 Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

    6.5 Leg weakness 1 52 Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

Comparison 2. ACUPUNCTURE VERSUS STEROID INJECTION

Outcome or subgroup title

No. of studies

No. of participants Statistical method Effect size

1 Pain Post Intervention

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   1.1 Rotator cuff disease

1 24 Mean Difference (IV, Fixed, 95% CI)

Not estimable

2 Range of abduction Post Intervention

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   2.1 Rotator cuff disease

1 24 Mean Difference (IV, Fixed, 95% CI)

Not estimable

3 Success rate (short Risk Ratio (M-H, Totals not

term) Fixed, 95% CI) selected

   3.1 Rotator cuff disease

1 24 Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

Comparison 3. ACUPUNCTURE VERSUS ULTRASOUND

Outcome or subgroup title

No. of studies

No. of participants Statistical method Effect size

1 Pain Post Intervention

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   1.1 Rotator cuff disease

1 24 Mean Difference (IV, Fixed, 95% CI)

Not estimable

2 Range of abduction Post Intervention

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   2.1 Rotator cuff disease

1 24 Mean Difference (IV, Fixed, 95% CI)

Not estimable

3 Success rate (short term)

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

   3.1 Rotator cuff disease

1 24 Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

Comparison 4. ELECTRO ACUPUNCTURE VERSUS STELLATE GANGLION AND SUPRASCAPULAR NERVE BLOCK

Outcome or subgroup title

No. of studies

No. of participants Statistical method Effect size

1 Pain at 30 hours Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   1.1 Adhesive capsulitis

1 100 Mean Difference (IV, Fixed, 95% CI)

Not estimable

2 Time to maximum pain relief

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   2.1 Adhesive capsulitis

1 100 Mean Difference (IV, Fixed, 95% CI)

Not estimable

3 Range of flexion after treatment

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   3.1 Adhesive capsulitis

1 100 Mean Difference (IV, Fixed, 95% CI)

Not estimable

Comparison 5. ACUPUNCTURE PLUS MOBILZATION VERSUS MOBILIZATION

Outcome or subgroup title

No. of studies

No. of participants

Statistical method Effect size

1 Pain at rest Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   1.1 General Shoulder Pain (No Diagnosis Given)

1 18 Mean Difference (IV, Fixed, 95% CI)

Not estimable

2 Pain on movement Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   2.1 General Shoulder Pain (No Diagnosis Given)

1 18 Mean Difference (IV, Fixed, 95% CI)

Not estimable

3 Active flexion Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   3.1 General Shoulder Pain (No Diagnosis Given)

1 18 Mean Difference (IV, Fixed, 95% CI)

Not estimable

4 Active abduction Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   4.1 General Shoulder Pain (No Diagnosis Given)

1 18 Mean Difference (IV, Fixed, 95% CI)

Not estimable

Comparison 7. ACUPUNCTURE VERSUS EXERCISE

Outcome or subgroup title

No. of studies

No. of participants

Statistical method Effect size

1 Constant Shoulder Assessment (Pain, Range of Motion, Function) post intervention

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

    1.1 Adhesive Capulitis 1 35 Mean Difference (IV, Fixed, 95% CI)

Not estimable

2 Constant Shoulder Assessment (Pain, Range of Motion, Function) 20 weeks

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

    2.1 Adhesive Capulitis 1 35 Mean Difference (IV, Fixed, 95% CI)

Not estimable

Comparison 8. ACUPUNCTURE VERSUS TRAGAR

Outcome or subgroup title

No. of studies

No. of participants

Statistical method Effect size

1 Wheelchair Users Shoulder Pain Index (WUSPI) post intervention

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   1.1 General Shoulder Pain (No Diagnosis Given)

1 18 Mean Difference (IV, Fixed, 95% CI)

Not estimable

2 Wheelchair Users Shoulder Pain Index (WUSPI) at 5 week follow-up

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   2.1 General Shoulder Pain (No Diagnosis Given)

1 18 Mean Difference (IV, Fixed, 95% CI)

Not estimable

Comparison 9. DEEP ACUPUNCTURE VERSUS SHALLOW ACUPUNCTURE

Outcome or subgroup title

No. of studies

No. of participants

Statistical method Effect size

1 McGill Pain Questionnaire Post Intervention

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   1.1 General Shoulder Pain (No Diagnosis Given)

1 44 Mean Difference (IV, Fixed, 95% CI)

Not estimable

2 McGill Pain Questionnaire 3 Months Follow-up

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

   2.1 General Shoulder Pain (No Diagnosis Given)

1 44 Mean Difference (IV, Fixed, 95% CI)

Not estimable

Comparison 10. TRADITIONAL ACUPUNCTURE VERSUS JING LUO ACUPUNCTURE

Outcome or subgroup title

No. of studies

No. of participants Statistical method Effect size

1 Recovery Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

    1.1 Periarthritis 1 98 Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

What's new

Last assessed as up-to-date: 22 February 2005

Date Event Description

16 June 2008 Amended Converted to new review format. A002-R

History

Protocol first published: Issue 4, 1998Review first published: Issue 2, 1999

Date Event Description

23 February 2005

New citation required and conclusions have changed

Substantive amendment

Contributions of authors

Sally Green and Rachelle Buchbinder modified and updated the protocol. Sally Green and Rachelle Buchbinder identified trials and extracted study results. Sally Green and Sarah Hetrick entered study details and results. All reviewers wrote and interpreted the review.

Declarations of interest

No author involved in this review has any known conflict of interest in regard to this review.

Sources of support

Internal sources • Australasian Cochrane Centre, Monash University, Australia.

ACUPUNCTURE AND ELECTROACUPUNCTURE: EVIDENCE-BASED TREATMENT GUIDELINES

DISEASE/CONDITION(S)

Conditions affecting the neuromusculoskeletal system, including:

Head and face conditions Neck conditions Shoulder conditions Elbow conditions Forearm, hand, and wrist conditions Thorax and low back conditions Hip and thigh conditions Knee conditions Ankle and foot conditions Chronic and postoperative pain Fibromyalgia

GUIDELINE CATEGORY

Treatment

CLINICAL SPECIALTY

Internal MedicineNeurologyOrthopedic SurgeryPhysical Medicine and Rehabilitation

RheumatologySports MedicineSurgery

INTENDED USERS

Health Care ProvidersHealth PlansManaged Care OrganizationsNursesPatientsPhysiciansUtilization Management

GUIDELINE OBJECTIVE(S)

To establish evidence-based best practice guidelines for acupuncture and electroacupuncture to be utilized by practitioners, patients, regulators, and third-party payors to make health-related decisions that result in medically sound treatment approaches that lead to effective and reproducible outcomes in the clinical setting

To standardize the approach to the application of acupuncture and electroacupuncture to various conditions of injury and ill health

To promote the appropriate utilization of these therapeutic interventions To ensure safe, effective, reliable, and cost effective care for the consumer To get the injured worker the treatment they need for recovery in the most timely manner in

order to allow for the return of that injured worker back to the workforce as quickly as possible

TARGET POPULATION

Patients with conditions affecting the neuromusculoskeletal system

INTERVENTIONS AND PRACTICES CONSIDERED

1. Acupuncture (needling therapy; trigger point) 2. Electroacupuncture (percutaneous electrical nerve stimulation; percutaneous neuromodulation

therapy)

MAJOR OUTCOMES CONSIDERED

Frequency of flare-ups or episodes of pain Duration of flare-ups or episodes of pain Sensitivity of pain to triggers and aggravating factors Incidence of paresthesias and stiffness Range of motion Strength and endurance Amount of bruising, discoloration, scars, swelling, tenderness Medication and aids use Frequency of relapse Incidence of hospital visits or other medical interventions

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)Hand-searches of Published Literature (Secondary Sources)Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Systematic Review of Published Literature

Two different searches were done on MEDLINE/PubMed to identify two categories of studies. The first was done to identify the largest, most comprehensive or systematic reviews available on acupuncture using the following search terms: "acupuncture", limiting the search to reviews in English, on human subjects, covering all dates from 1998 (post-National Institutes of Health [NIH] consensus statement on acupuncture) up to July, 2004. This search identified 375 reviews. The second search was done to locate high-quality positive outcome trials on acupuncture using the following search terms: "acupuncture or electroacupuncture", limiting the search to randomized controlled trials, in English, on human subjects, covering all dates up to July, 2004. This search identified 486 randomized controlled trials. The full articles were located and the references and bibliographies of these articles were searched for other potential comprehensive reviews and randomized controlled trials that may have been missed in the original MEDLINE searches. These potentially useful reviews and randomized controlled trials were then screened and selected using the same selection criteria as applied previously.

Selection Criteria - Published Research Reviews

For the first search, the most comprehensive reviews, overviews. and summaries done in English after 1997, were given priority and selected for review. It was the intention of the authors to draw upon the most comprehensive post-NIH overviews and reviews done to date as a basis for the current recommendations in order to ensure the most appropriate recommendations available and minimize the risk for biased conclusions. The inclusion criteria for the selection of these reviews and summaries were the following: 1) the review or overview was a review or a summary of other reviews (including systematic reviews) not individual trials, 2) conclusions were made on acupuncture for neuromusculoskeletal conditions, 3) the review or summary was done after 1997 (post-NIH), and 4) in the English language.

Selection Criteria - Randomized Controlled Trials

For the second search, 486 randomized controlled trials were found matching the above search terms. These were selected based on the following criteria: 1) trials were randomized or quasi-randomized, 2) controlled (with the control consisting of one of the following: no treatment, treatment as usual, placebo, sham acupuncture, or active control), 3) experimental treatment consisting of either acupuncture or electroacupuncture (or PENS: percutaneous electroneural stimulation, or PNT: percutaneous neuromodulation therapy), 4) the trial was on a type of neuromusculoskeletal condition, 5) there was some degree of clinical effectiveness of the experimental therapy reported and 6) available in the English language. Trials which reported sufficient sample size (over 30 in treatment group), blinding, statistical significance and other inferential statistics were preferred for selection in order to maintain high quality of studies considered.

NIH and WHO Reports

Additionally, the NIH Consensus Statement (1998) and the World Health Organization's Acupuncture: Review and Analysis of Reports of Controlled Clinical Trials, (1999) were included to serve as an evidence basis due to their unique size, scope of the studies, the participation of a large

number and variety of reviewers, and the sponsorship by highly credible, independent government and non-government agencies, even though these reviews did not meet the above inclusion criteria. A summary of the objectives and methods used in the development of their recommendations is provided in the original guideline document.

NUMBER OF SOURCE DOCUMENTS

Five reviews, overviews, or summaries met the inclusion criteria and were selected. A total of 72 randomized controlled trials supporting the efficacy of acupuncture for various

neuromusculoskeletal conditions were found to meet the inclusion criteria.

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-AnalysesSystematic Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Communication and Meetings

The formulation of the treatment recommendations were made by communication through phone conferences, electronic mail, and occasional face-to-face meetings. Over thirty such meetings were conducted, during which discussion took place on various issues regarding the content of the guidelines, including the recommendations for treatment.

Decision-Making

Decisions were arrived at by consensus among participants following discussion of the issue in question. When there was disagreement on an issue, open discussion was encouraged, then the issue would go to the editorial committee, and then to an executive committee for final decision.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

A. A strong recommendation, based on an evaluation of the available evidence and general consensus of the expert panel, that acupuncture and electroacupuncture treatment is effective, always acceptable, and indicated

B. A recommendation that was based on an evaluation of the available evidence and general consensus of the expert panel that acupuncture and electroacupuncture treatment should be considered acceptable, effective, and indicated.

C. A recommendation that is not well established by evidence, or for which there is conflicting evidence regarding usefulness or efficacy, but which the expert panel has determined that acupuncture and electroacupuncture treatment may be acceptable, effective, and indicated.

D. A recommendation, based on evidence or general agreement, that acupuncture and electroacupuncture treatment may be considered not useful or effective.

E. A strong recommendation, based on evidence or general agreement, that a given procedure or treatment is not useful or effective, or in some cases may be harmful, and should be excluded from consideration.

COST ANALYSIS

Cost Efficacy of Acupuncture

Although cost efficacy studies are relatively few, there are a number of studies suggesting the potential for vast savings to our healthcare system by avoiding surgeries, reducing expensive medical treatments and returning injured workers to work earlier has been well documented.

For example, in a study of 56 male patients who were being rehabilitated at a workers' compensation clinic for chronic low back pain (average duration 28.6 weeks), and who had already failed standard therapy, were randomly assigned to either continue standard therapy or receive standard therapy plus acupuncture. Standard therapy consisted of physical therapy, remedial exercises, and occupational therapy. Acupuncture, with electrical stimulation of the needles, was administered at variable sites depending on the location of the pain, for variable numbers of treatment sessions up to a maximum of 15, (mean 7/9), depending on response to treatment. Of the 29 patients that received acupuncture, 18 returned to their original or equivalent jobs; an additional 10 returned to lighter employment. Of the 27 who received only standard therapy, 4 returned to their original or equivalent jobs and 14 to lighter employment. The significance of this study is that this study showed that a relatively simple course of acupuncture added into a standard rehabilitation program for patients with chronic back pain was found to significantly improve the treatment outcome when compared to effects of the rehabilitation program administered alone. Many more of those who received acupuncture as supplemental care were able to return to their previous type of employment.

In another study, 65 patients with pain, mainly of musculoskeletal origin, were offered treatment by an acupuncturist as an alternative to hospital outpatient referral. The cost of acupuncture treatment was compared to that of the referral that would have been made if acupuncture had not been offered. The acupuncture was found to have cost $21, 886.00 (London Exchange) U.S. dollars against the cost for hospital referrals of $53, 566.00. A minimum total saving for all patients was $27,832.00 giving an average saving per patient of $464.00. Additional hidden savings through avoiding further hospital procedures and expenditure on medication were not taken into account. The study concluded that "acupuncture in selected patients and when used by an appropriately qualified practitioner appears to be a cost effective therapy for use in general practice, reducing the need for more expensive hospital referrals."

In another study 29 patients with severe osteoarthritis of the knee (42 knees), each of whom was awaiting arthroplasty surgery, were randomized to receive a course of  acupuncture treatment or be placed on a wait list and receive a course of acupuncture treatments starting 9 weeks later. At the end of the study, 7 patients were able to avoid surgery, at a savings of $9,000 per operation.

METHOD OF GUIDELINE VALIDATION

Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not stated

MAJOR RECOMMENDATIONS

Definitions for the quality of the evidence (Levels I-IV) and the strength of recommendations (Grades A-E) are found at the end of the "Major Recommendations" field.

Electroacupuncture (EA)

General Operational Guidelines

The physiological features of the body allow the use of simple, rational, repeatable rules for the application of EA. This includes proper placement of the output leads to achieve the best therapeutic effect while at the same avoiding unwanted current paths in the body. Perhaps the most important consideration in the use of EA, and acupuncture in general, is the selection of candidate neurovascular nodes (acupoints) to be employed to achieve the best clinical outcome for the patient's condition. Duration of treatment, output amplitude, output frequency, and selection of proper operating mode also need to be considered. (Details are provided in the original guideline document.)

When to Consider Using EA

Generally the application of EA stimulation greatly enhances the effect of needling therapy and can increase level of analgesia and significantly extends the period of treatment effectiveness. Many practitioners apply EA as a primary modality for acute and chronic pain and musculoskeletal problems because of its ability to produce a strong analgesic effect. The application of EA is a primary consideration for pain, muscle spasms, numbness, treating nerve dysfunction, paralysis, and atrophy. EA can also be employed in surgical or dental procedures an adjuvant to normal anesthetics. EA is very effective in treating withdrawal symptoms of individuals quitting the use of addictive substances such as nicotine, alcohol, cocaine, opiates, and some prescription drugs. EA can also be used to enhance cervical dilatation and uterine contractions to induce labor. Stimulation promotes tissue repair, healing and regenerating of nerve fibers essential to treat many chronic disorders.

Placement of Leads

Physiological organization of the body that is critical to afferent and efferent processes affecting the vessels, viscera, muscles, and peripheral nerves is basically longitudinal and ipsilateral in nature. The ipsilateral nature of the ascending afferent signals dictates placing the positive and negative leads of one particular output channel of the EA/PENS device along vertical pathways on the same side of the body. One principal goal in lead placement is to conform to the segmental and axial organization of the body while making certain to prevent cross currents. Cross currents are to be avoided especially in preventing transcranial current pathways.

This is accomplished by placing the positive and negative leads of one particular output channel of the EA/PENS device along vertical pathways on the same side of the body. If the presenting problem is ipsilateral in nature, such as pain in one shoulder, the positive and negative leads are placed at appropriate locations along the affected muscular pathway. If the problem is bilateral, such as low back pain, then one set of positive and negative leads, are placed on one side of the back, and another set placed at the same relative locations on the other side. However, there is about a 40% crossover on the descending control restorative signals. This crossover features allows treatment of the opposite side to the one containing a problem to benefit the affected side, especially where the patient cannot tolerate direct treatment of the affected side.

Duration of Stimulation

Typical duration of EA application is 15 to 30 minutes. In cases of dental or surgical analgesia, the duration may by longer. In treatment of withdrawal from a powerful opiate, the duration may be increased to 45 minutes and applied twice a day for 3 to 4 days.

Amplitude (Strength of Current)

Under most conditions, amplitude of the output signal is only adjusted to the level that the patient can detect a slight sensation that feels like tapping on the skin. In many cases of trauma and pain there may be a deficit in sensory perception. These patients may not feel the electrical signal even though strong muscular contractions are activated. Thus, amplitude is adjusted only to the level where either the patient feels a slight sensation or the practitioner observes small movements of the needle or perhaps very slight muscular contractions. Excess strength of stimulation can induce a stress response. After several minutes of stimulation, control signals generated in the body, reduce the response to the stimulus and the patient no longer feels the EA stimulus. Thus, the amplitude is periodically readjusted to maintain an awareness of a slight tapping sensation. The control response generated by the body is mediated by descending neural pathways in the spinal cord. This is the prime effect that is sought in the treatment of all problems, including musculoskeletal and viscera conditions.

Frequency and Operating Mode

Care needs to be taken not to induce stress by either excess amplitude or using frequencies that are too high.

Low frequency application (2 hertz [Hz].) always invokes the analgesic and restorative processes of acupuncture. This frequency (2 Hz.) is suitable for use in treating all pain conditions, substance abuse, osteoarthritis, rheumatoid arthritis, vascular or blood distribution problems and organ dysfunction. Higher frequencies (25 to 50 Hz.) are selected where nerve dysfunction or paralysis is involved and this is usually in conjunction with a low frequency (mixed mode). Frequencies of 25 Hz. and above can produce tonic contraction of muscles and is useful in treating certain muscular conditions when applied in discontinuous or mixed mode. General considerations of mode selection involve the following:

Continuous mode: Used for most conditions, especially in treating pain, substance withdrawal symptoms, visceral problems, inducing labor, and using EA/PENS for surgical analgesia. Normal treatment duration is about 20-35 minutes and there is little risk of developing tolerance even if this is applied several times a day. When used for surgical or dental analgesia, the duration may be extended. Tolerance can be produced after many hours of continuous application or in several days with a few hours of daily EA/PENS stimulation

Mixed mode: Is considered when a clinical condition involves paralysis, atrophy, and impairment due to loss of nerve function. Mixed mode can also be applied to enhance segmental levels with the higher frequency component as well as activating axial effects with the lower frequency component.

Discontinuous mode: Employed where a longer period of stimulation is needed and also where stimulation is directed to strengthen particular muscular areas or to treat problems such as scoliosis. In situations of long duration EA/PENS, use of discontinuous mode (about 3 seconds on and 3 seconds off) can be considered to reduce potential of developing tolerance

General Precautions and Contraindications for EA

Profound analgesia induced by EA puts patient at risk of self injury, therefore the patient must be advised or restricted from strenuous physical activity after treatment.

Contraindicated in left chest region for patients with cardiac pacemakers, or for areas with imbedded neural stimulators and other electrical devices.

Not to be used on lower abdomen in pregnant women. High frequency or high amplitude application may induce stress, which is contraindicated in

cases of hypertension. High amplitude EA that causes muscle fiber recruitment (twitching) can irritate or re-injure

acute local strains and sprains. EA can sedate older or fatigued patients, causing drowsiness after treatment; hence some

patients should arrange for others to drive them home after an EA treatment.

Treatment Guidelines

Acupuncture and electroacupuncture therapy have been utilized to treat a broad spectrum of illnesses and injuries, and have proven particularly effective at treating anatomically localized neuromusculoskeletal (NMS) injuries caused by repetitive stress or trauma. The anatomical NMS injuries that are most typically treated by acupuncture and electroacupuncture are due to trauma, sports injuries, auto accidents, and work-related repetitive stress injuries of the tendon, ligament, and bursa, and injuries in and around joint areas and the soft tissues (muscles, ligaments, etc) surrounding the spine. Acupuncture and electroacupuncture are also commonly used to treat chronic or post-operative pain, headaches, nausea, menstrual-related pain, and other conditions that may be anatomically, neurologically, or physiologically based.

Severity and Duration of Conditions

Conditions of illness and injury are generally classified into three or more categories, depending upon severity and duration. The commonly used descriptions of the stages of illness and injuries are acute, sub-acute, chronic, and recurrent.

Acute - Having rapid onset, relatively brief duration, and severe symptoms; which have duration within four weeks of onset.

Sub-Acute - Somewhat less than acute in severity, intermediate in character between acute and chronic symptoms within three months duration from onset of symptoms.

Chronic - Injury of long duration and/or frequent recurrence of longer than three months duration.

Recurrent/Flare-Up - Return of symptoms of original injury at intervals or as a result of aggravating factors.

Treatment Frequency and Duration

The effects of acupuncture are generally cumulative. Acupuncture initiates physiologic tissue restorative and regenerative mechanisms. (See Physiological Mechanisms of Action in the original guideline document.) Frequency and duration of treatment are based on several factors including severity of condition, chronicity (duration of condition), previous episodes, pre-existing conditions, and other complicating factors. Such complicating factors present inherent difficulties in recovery, therefore, extra time and treatment is appropriate in order to observe a therapeutic response. The therapeutic effects of treatment should be assessed by subjective and objective assessments after each course of treatment. (See Measurable Outcomes in the original guideline document.)

Normally an initial course of treatment consists of 12 to 18 treatments over a 4 to 6 week period, depending on complicating factors. For acute conditions, fewer treatments may be necessary to observe a therapeutic effect and to obtain complete recovery. For chronic conditions, and conditions with complicating factors, extended treatment is recommended to observe response to treatment. As in most types of therapy, the earlier the patient receives treatment, the greater the probability of recovery, and the shorter the time to recovery.

Acupuncture is commonly utilized in chronic conditions because of effectiveness in pain management and limited treatment options. However, it should be noted that acupuncture and electroacupuncture can lead to complete recovery in many NMS conditions when it is offered in the acute and sub-acute stages of injury, particularly when used in conjunction with other therapeutic interventions, such as range of motion (ROM) and strengthening exercises and manual manipulation of the soft tissue.

Acupuncture or electroacupuncture are rarely performed as a single treatment, but are usually prescribed and performed as a series, or "course of treatments." Thus, treatment planning requires a recommendation for the number, frequency, and duration of treatments that is appropriately based upon the nature and extent of the injuries and the prognosis for a progressive and timely recovery from those injuries. Severe injuries, multiple injuries, metabolic disorders, and other complicating factors may require more frequent treatments over a longer duration of time. For example, while some multiple injuries can be treated simultaneously, others must be treated independently and sequentially, requiring increased treatment frequency.

The following recommendations for the frequency and duration of treatment are based upon moderate to severe injuries in an otherwise healthy patient. Individual case recommendations should be scaled accordingly.

Acute - 3 treatments per week, decreasing frequency as symptoms resolve and are reduced. Sub-Acute - 3 treatments per week for up to four weeks. 2 treatments per week thereafter.

This is also the time when a rehabilitation exercise program is usually introduced. Chronic - 2 to 3 treatments per week for up to eight weeks as an initial course of treatment,

and 1 to 2 treatment per week thereafter. Recurrent/Flare-Up - 8 to 12 visits as needed over a 2 month period

Initial Course of Treatments

Frequency and Duration for Initial (Trial) Course of Treatments

Stage of Condition Frequency Duration Re-evaluate after:

Acute 3x weekly 4 weeks 12 treatments

Sub-Acute 3x weekly 4 weeks 12 treatments

Chronic 2 to 3x weekly 6 to 8 weeks 12 treatments

Recurrent/Flare-up2 to 3x weekly 4 to 8 weeks 12 treatments

A detailed or focused re-evaluation designed to determine the patient's progress and response to treatment should be conducted at the end of each course of treatment. Additionally, a brief assessment of the patients response to each treatment should be noted after each treatment is completed, and again before the next one is started, and recorded in progress notes (e.g., SOAP notes). When a patient's condition is not responding to treatment for a period of 2 to 3 weeks, a more thorough re-evaluation should be conducted immediately to determine if the condition is different or more serious than the initial diagnosis had indicated and/or whether the condition requires further diagnostic testing and/or referral to other diagnostic or treatment specialists.

Re-Evaluation and Re-examination

After an initial course of treatment has been concluded, the detailed or focused re-evaluation should determine whether the objectives of the initial treatment plan have been fulfilled, and the extent to which they have been fulfilled by the documentation of subjective and objective assessments. A determination and recommendation must be made as to whether an additional course of treatment would continue to contribute to the patient's recovery or not. In general, if the patient is showing

improvement in subjective and objective assessments from the previous evaluation, then continued therapy is indicated. (See Measurable Outcomes in the original guideline document). Additionally, if the goals of the treatment are reached, and there is documentation of subjective and objective outcomes in the patient's condition, it is appropriate to continue the therapy. (See Outcome Expectations in the original guideline document). If not, the patient should be referred for an alternative treatment or re-evaluation by a specialist after showing no response to the initial course of treatment.

Course of Continuing Treatments

Follow-up courses of treatment may be similar in frequency and duration to the initial course of treatment. However, one of the goals of any treatment plan should be to reduce the frequency of treatments to the point where maximum therapeutic benefit continues to be achieved while encouraging more active self-therapy, such as strengthening and range-of-motion (ROM) exercises, and rehabilitative exercises. The frequency of continued treatment generally depends upon the severity and duration of the condition; treatment benefits are generally stronger and last longer as a condition moves from acute towards complete resolution and as the patient takes a more active role in his or her recovery.

Frequency and Duration for Continuing Courses of Treatments

Stage of Condition Frequency Duration Re-evaluate after:

Acute 2 to 3x weekly 4 weeks 12 treatments

Sub-Acute 2 to 3x weekly 4 weeks 12 treatments

Chronic 1 to 2x weekly 6 to 8 weeks 12 treatments

Recurrent/Flare-up1 to 2x weekly 4 to 8 weeks 12 treatments

When the patient's condition stabilizes, or no longer shows improvement from the therapy, a decision must be made on whether to continue treatment in order to stabilize and maintain the patient's progress, or to discontinue therapy. In some cases of chronic pain, it may be appropriate to utilize acupuncture for pain management, for example, for patients who have adverse reactions to pain medications or when the prescribed pain medications are not sufficient to manage the patient's chronic pain. This decision is based on a number of factors, including the potential benefit of the therapy and the potential risks involved in that therapy.

Duration and Frequency for Courses of Treatments for Neuromusculoskeletal Conditions

Stage of Condition Initial Course Follow-up Course(s) Re-evaluate after:

Frequency Duration Frequency Duration  

Acute 3x weekly 4 weeks 2 to 3x weekly 4 weeks 12 treatments

Sub-Acute 3x weekly 4 weeks 2 to 3x weekly 4 weeks 12 treatments

Chronic 2 to 3x weekly 6 to 8 weeks 1 to 2x weekly 6 to 8 weeks 12 treatments

Recurrent/Flare-up2 to 3x weekly 4 to 8 weeks 1 to 2x weekly 4 to 8 weeks 12 treatments

Patient Health and Safety

Identification and diagnosis of a condition/disorder is substantiated through historical data related to the chief complaint, onset of the condition, type of symptoms and their character, and previous history related to the condition. In addition, findings from the physical examination assist in defining the severity of involvement and the specific diagnosis.

In order to protect the health and safety of patients, quality of care strategies for reducing clinical errors and improving patient safety should be observed. These strategies include encouraging practitioners to adopt evidence-based health care approaches to patient care, maintain their clinical skills at or above broadly accepted professional standards of care, and follow applicable case management guidelines.

Evidence based healthcare, provided by properly trained providers, is one of the most conservative, least invasive, and safest types of health care. This being said, it is important to note that all forms of treatment carry some risk of harm to the patient and acupuncture and electroacupuncture are no exception. Therefore, implementing basic risk management procedures that recognize, avoid, and manage actual or alleged adverse outcomes, can help clinicians minimize the risk of harm or injury to patients.

Improving Patient Health and Safety

The following goals are useful in improving patient health and safety:

1. Identify types and causes of adverse outcomes 2. Educate oneself regarding patient safety standards 3. Decrease the incidence of adverse events through the identification of preventable events and

risk factors 4. Facilitate the reporting of adverse outcomes 5. Support or participate in studies to improve patient safety-related clinical outcomes

Cautions and Contraindications

Besides conditions for which acupuncture and electroacupuncture may not be appropriate or medically necessary, there are also certain clinical situations where acupuncture or electroacupuncture are contraindicated, or where a patient's condition must be co-managed by multiple healthcare specialists.

Conditions Contraindicating Acupuncture:

Acupuncture is contraindicated in patients or areas of the body when certain complicating conditions are present, such as:

Open wound or burn Prolonged bleeding time/hemophilia Artificial joint implants Pacemaker

Conditions Requiring Co-management

Acupuncture should only be used as an adjunct to another form of standard medical intervention, under co-managed care with other health care personnel for certain conditions, such as:

Cancer pain Chemotherapy-induced nausea Post-operative surgical pain Multiple sclerosis related pain Labor inducement for pregnancy

Conditions Requiring Referral

Patients should be referred to another specialty health care practitioner or to emergency care in certain instances, such as:

The patient's condition is not responding to the treatment rendered. The patient's condition is worsening with treatment. The patient has an unmanaged progressive infectious condition. The patient experiences a medical emergency (e.g., heart attack, laceration, pneumothorax). A broken needle requires surgical removal.

Conditions Requiring Special Care

Conditions for which acupuncture may be contraindicated, or must be modified, due to individual circumstances:

Pregnancy (avoid strong stimulation of acupoints LI 4, Sp 6, UB 60, UB 67, except to induce labor; avoid low back and abdominal points during last trimester)

Informed Consent

The provider of the medical procedure should explain the procedure in writing and verbally, including potential benefits and risks. The patient must be given the opportunity to ask questions and the medical provider should discuss treatment alternatives.

Head and Neck

A. Head

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of head conditions:

Tension Headache Migraine HeadacheCluster HeadacheSinus HeadacheHypertensive HeadacheCervicogenic HeadacheHead TraumaTemporomandibular DysfunctionFacial Pain

Quality of Evidence: Level I

Recommendation Grade: Grade A

(References supporting the recommendation: Vickers et al., 2004; Allais et al., 2002; Liguori et al., 2000; Wonderling et al., 2004; Xue et al., 2004; Ahonen et al., 1983; Allais et al., 2003; Hansen & Hansen, 1985; Karakurum et al., 2001; Karst et al., 2001; Ghoname, Craig, & White, 1999; British Medical Association Board of Science & Education, 2000; Kaptchuk, 2002; "Acupuncture," 1997; World Health Organization (WHO), 1999)

B. Neck

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of neck conditions:

Injuries to the Cervical SpineCervical Strain and WhiplashCervical RadiculopathyCervical Stenosis and SpondylosisHerniated Cervical DiscTorticolisUnspecified Neck PainCervical ArthritisDegenerative Disc DiseaseMuscle Spasm

Quality of Evidence: Level I

Recommendation Grade: Grade A

(References supporting the recommendation: Birch & Jamison, 1998; He et al., 2004; Irnich et al., 2001; Irnich et al., 2002; Coan, Wong, & Coan, 1980; David et al., 1998; Konig et al., 2003; Loy, 1983; Nabeta & Kawakita, 2002; Petrie & Langley, 1983; Sator-Katzenschlager et al., 2003; Yue, 1978; Zhu & Polus, 2002; British Medical Association Board of Science & Education, 2000; "Acupuncture," 1997; WHO, 1999; Kaptchuk, 2002; Ernst, 1999; Linde et al., 2001).

Upper Extremity

A. Shoulder

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of shoulder conditions:

Injuries to the Shoulder – GeneralAcromioclavicular JointSeparation/CompressionRotator Cuff TearBiceps Tendon InjuryAdhesive Capsulitis (Frozen Shoulder)Shoulder Tendinitis/BursitisThoracic Outlet SyndromeMuscle Spasm

Quality of Evidence: Level II

Recommendation Grade: Grade A

(References supporting the recommendation: Sun et al., 2001; Kleinhenz et al., 1999; Dyson-Hudson et al., 2001; Kaptchuk, 2002; "Acupuncture," 1997; WHO, 1999)

B. Elbow

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of elbow conditions:

Lateral EpicondylitisMedial EpicondylitisOlecranon BursitisUlnar Neuritis

In general, the application of acupuncture is recommended in the first 4 weeks of treatment as a part of an overall, initial, conservative, treatment plan. Specifically 3 to 6 acupuncture treatments over 7 to 21 days are listed as one Official Disability Guideline "Return-To-Work Pathway" for lateral epicondylitis (Work Loss Data Institute, 2003).

Quality of Evidence: Level I

Recommendation Grade: Grade A

(References supporting the recommendation: Trinh et al., 2004; Fink et al., "Acupuncture," 2002; Fink et al., "Chronic epicondylitis," 2002; Tsui & Leung, 2002; Brattberg, 1983; British Medical Association Board of Science & Education, 2000; WHO, 1999)

C. Forearm, Hand and Wrist

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of forearm, hand, and wrist conditions:

Forearm Sprain/StrainCarpal Tunnel SyndromeDeQuervains SyndromeTrigger FingerWrist/Finger Sprain/StrainTendinitis of Forearm/WristArthritis

Quality of Evidence: Level II

Recommendation Grade: Grade B

(References supporting the recommendation: Kaptchuk, 2002; "Acupuncture," 1997; WHO, 1999; Naeser et al., 2002)

Torso and Low Back

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of thorax and low back conditions:

Thoracolumbar Area

Injuries to the CostalsLow Back Sprain/StrainLumbar Facet SyndromeLumbar Disc HerniationSciatic NeuralgiaSacroiliac Sprain/StrainSpondylolisthesisSpondylosis

Muscle SpasmsLumbar RadiculopathyDegenerative Disc Disease

Quality of Evidence: Level I

Recommendation Grade: Grade A

(References supporting the recommendation: Carlsson & Sjolund, 2001; Meng et al. 2003; Molsberger et al. 2002; Ceccherelli et al. 2002; Lehmann et al. 1986; Leibing et al. 2002; Thomas & Lundberg 1994; Tsukayama et al. 2002; Wang & Tronnier, 2000; Yeung, Leung, & Chow, 2003; Coan et al. 1980; Grant et al., 1999; Kerr, Walsh, & Baxter, 2003; Kvorning et al. 2004; Leung, 1973; Mendelson et al., 1983; Sator-Katzenschlager et al. 2004; Condon et al., 2002; Ernst & White, 1998; Ghoname et al., "Percutaneous electrical nerve," 1999; Ghoname et al., "Acupuncture & sciatica," 1999; Ghoname et al, "The effect of stimulus," 1999; Guerreiro et al., 2004; Hamza et al. 1999; Ernst & White, 1998; Tait, Brooks, & Harstall, 2002; Kaptchuk, 2002; "Acupuncture," 1997; WHO, 1999; Linde et al., 2001)

Lower Extremity

A. Hip and Thigh

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of hip and thigh conditions:

OsteoarthritisMuscle SpasmTendinitis/BursitisPiriformis SyndromeCapsulitisAvascular NecrosisPost-Operative Fractures & Hip Replacements

Quality of Evidence: Level II

Recommendation Grade: Grade A

(References supporting the recommendation: Fink, Wipperman, & Gehrke, 2001; Haslam, 2001; Stener-Victorin, Kruse-Smidje, & Jung, 2004; "Acupuncture," 1997; WHO, 1999)

B. Knee

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of knee conditions:

OsteoarthritisTendinitisLigament InjuriesMeniscus InjuriesPatellofemoral PainPost-Operative PainBakers Cyst

Quality of Evidence: Level I

Recommendation Grade: Grade A

(References supporting the recommendation: Berman et al. 1999; Tukmachi et al. 2004; Jensen et al., 1999; Ng, Leung, & Poon, 2003; Vas, Perea-Milla, & Mendez, 2004; Naslund et al., 2002; Singh et al., 2001; Ezzo et al., 2001; "Acupuncture," 1997; WHO, 1999)

C. Ankle and Foot

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of ankle and foot conditions:

Ankle SprainAchilles TendinitisPlantar FascitisTarsal Tunnel SyndromeDiabetic NeuropathyReflex Sympathetic DystrophyOsteoarthritisPost-Operative Pain

Quality of Evidence: Level IV

Recommendation Grade: Grade B

(References supporting the recommendation: Hamza et al., 2000; "Acupuncture," 1997; WHO, 1999)

14. Chronic and Postoperative Pain

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of chronic and postoperative pain conditions:

"Acupuncture, in combination with pharmacological interventions, may lower the need for medication and reduce the risk for side effects from these drugs (NIH, 2001)."

"Acupuncture may reduce nausea and vomiting if used in early postoperative period ("Acupuncture," 1997)."

Quality of Evidence: Level II

Recommendation Grade: Grade A

(References supporting the recommendation: Martelete & Fiori, 1985; Ghia et al., 1976; Junnila, 1987; WHO, 1999; Eshkevari, 2003; Tait, Brooks, & Harstall, 2002; Kaptchuk, 2002; "Acupuncture," 1997; WHO, 1999)

15. Systemic and Non-Regional Conditions A. Fibromyalgia

The use of acupuncture and electroacupuncture is appropriate for, but not limited to, the following types of systemic and non-regional conditions:

Fibromyalgia

Quality of Evidence: Level II

Recommendation Grade: Grade A

(References supporting the recommendation: Berman et al, 1999; Deluze et al. 1992; British Medical Association Board of Science & Education, 2000; Tait, Brooks, & Harstall, 2002; Kaptchuk, 2002; "Acupuncture," 1997; WHO, 1999)

Definitions:

A. Quality of Evidence I. Multiple well-designed, randomized controlled trials, directly relevant to the

recommendation, yielded a consistent pattern of findings. II. Evidence was obtained from at least one properly well-designed randomized

controlled trial (RCT). III. Evidence was obtained from well-designed controlled trials without randomization. IV. Evidence consisted of the opinions of respected authorities, based on clinical

experience, descriptive studies in case reports, or reports of expert committees.

B. Recommendation Grades A. A strong recommendation, based on an evaluation of the available evidence and

general consensus of the expert panel, that acupuncture and electroacupuncture treatment is effective, always acceptable, and indicated

B. A recommendation that was based on an evaluation of the available evidence and general consensus of the expert panel that acupuncture and electroacupuncture treatment should be considered acceptable, effective, and indicated.

C. A recommendation that is not well established by evidence, or for which there is conflicting evidence regarding usefulness or efficacy, but which the expert panel has determined that acupuncture and electroacupuncture treatment may be acceptable, effective, and indicated.

D. A recommendation, based on evidence or general agreement, that acupuncture and electroacupuncture treatment may be considered not useful or effective.

E. A strong recommendation, based on evidence or general agreement, that a given procedure or treatment is not useful or effective, or in some cases may be harmful, and should be excluded from consideration.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations."

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Appropriate use of acupuncture and electroacupuncture, leading to safe, effective, reliable, and cost-effective care for the consumer

POTENTIAL HARMS

Profound analgesia induced by electroacupuncture (EA) puts patient at risk of self injury, therefore the patient must be advised or restricted from strenuous physical activity after treatment.

High amplitude EA that causes muscle fiber recruitment (twitching) can irritate or re-injure acute local strains and sprains.

EA can sedate older or fatigued patients, causing drowsiness after treatment; hence some patients should arrange for others to drive them home after an EA treatment.

CONTRAINDICATIONS

CONTRAINDICATIONS

Acupuncture is contraindicated in patients or areas of the body when certain complicating conditions are present, such as:

Open wound or burn Prolonged bleeding time/hemophilia Artificial joint implants Pacemaker

Electroacupuncture:

Contraindicated in left chest region for patients with cardiac pacemakers, or for areas with imbedded neural stimulators and other electrical devices

Not to be used on lower abdomen in pregnant women High frequency or high amplitude application may induce stress, which is contraindicated in

cases of hypertension.

Conditions for which acupuncture may be contraindicated, or must be modified, due to individual circumstances:

Pregnancy (avoid strong stimulation of acupoints LI 4, Sp 6, UB 60, UB 67, except to induce labor; avoid low back and abdominal points during last trimester)

QUALIFYING STATEMENTS

The Council of Acupuncture and Oriental Medicine Associations provides these guidelines for health care practitioners and notes that decisions to recommend particular courses of treatment can only be made by qualified practitioners on the basis of their training, knowledge, and experience and in consideration of the particular conditions present in any individual patient. The Council of Acupuncture and Oriental Medicine Associations disclaim responsibility for any injury or damage resulted from any action or inaction taken by practitioners after consideration of these guidelines.

These guidelines address frequency, intensity, and duration of treatment but do not make specific recommendations on styles of acupuncture, diagnostic methods, and point selection involved in the acupuncture treatments. The reason for this is due to the variety of effective acupuncture techniques currently being used in this country, and the fact that a particular

patient may respond to one technique more readily than another. It is the responsibility of the practitioner to adopt the most effective technique and point selection for each patient's needs.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

Organizational Considerations

There are a number of organizational barriers that will need to be overcome to implement these guidelines. These include a limited understanding and awareness of the efficacy and therapeutic benefit of acupuncture in treating neuromusculoskeletal conditions in acute, subacute and chronic stages, and the accompanying skepticism of the medical value of acupuncture. Consequently, most medical providers do not consider acupuncture as a primary modality for treating neuromusculoskeletal conditions. All too often acupuncture is used as a last resort for pain management when all other therapies have failed.

The delay of appropriate therapy can lead to delayed recovery, reduced quality of life, inability to work, preventable surgeries, expensive tests, chronic pain, increased risks of side effects due to pain medications or anti-depressants, long term rehabilitation, treatment that may have marginal beneficial results and perhaps irreparable complications. This in turn leads to increased costs to insurance carriers to provide long term medical treatment for chronic conditions which could otherwise be avoided. Educating decision makers of the benefits, safety and efficacy of acupuncture applied earlier in the treatment of injured patients will ensure the most appropriate and effective treatments for the patients.

Cost Considerations

The related cost implications are negligible. An educational program geared towards medical personnel and case managers (decision makers) already exists. These guidelines will simply supplement or replace existing printed material, web references and resources delivered on a monthly or quarterly basis. Face to face interaction between practitioners and the medical decision makers in the form of seminars and lectures will guarantee that the information will be delivered, received, understood and applied in the most appropriate manner. Members of the acupuncture profession are available to perform this task.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting BetterLiving with Illness

IOM DOMAIN

EffectivenessPatient-centeredness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

Council of Acupuncture and Oriental Medicine Associates (CAOMA), Foundation for Acupuncture Research. Acupuncture and electroacupuncture. Evidence-based treatment guidelines. Calistoga (CA): Council of Acupuncture and Oriental Medicine Associates (CAOMA); 2004 Dec. 111 p. [91 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2004 Dec

GUIDELINE DEVELOPER(S)

Council of Acupuncture and Oriental Medicine Associations - Professional AssociationFoundation for Acupuncture Research - Professional Association

SOURCE(S) OF FUNDING

Council of Acupuncture and Oriental Medicine Associations

GUIDELINE COMMITTEE

Not stated

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Primary Editors: Brian C. Fennen, LAc, QME, OBT; Richard A. Esquivel, LAc, DNBAO, QME

Contributing Editors: Burton L. Alperson, PhD; Robin Hays, LAc, DNBAO; Donald Kendall, LAc, OMD, PhD; Michelle Lau, LAc, PhD; Ted Priebe, LAc, OMD, DNBAO; Nancy Rakela, LAc, DNBAO; Shasta Tayam, Lac; Anthony Von der Muhll, LAc

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

ENDORSER(S)

Acupuncture and Oriental Medicine National Coalition - Professional AssociationAcupuncture Association of Rhode Island - Professional AssociationAmerican Academy of Medical Acupuncturists - Professional AssociationCalifornia Society of Physical Medicine and Rehabilitation - Professional AssociationCalifornia State Oriental Medicine Association - Professional AssociationNational Oriental Medicine Accreditation Agency - Medical Specialty SocietyTraditional Chinese Medicine Association and Alumni, Inc. - Professional Association

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

For electronic or print copies contact the Council of Acupuncture and Oriental Medicine Associations, 1217 Washington Street, Calistoga, CA 94515; Web site: www.acucouncil.org.

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on August 24, 2006.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is copyrighted by the Council of Acupuncture and Oriental Medicine Associations.

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