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Original Article http://mjiri.iums.ac.ir Medical Journal of the Islamic Republic of Iran (MJIRI) Iran University of Medical Sciences ____________________________________________________________________________________________________________________ 1 . MD, Associate Professor, Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. [email protected] 2 .(Corresponding author) MD, Assistant Professor, Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilita- tion, Iran University of Medical Sciences, Tehran, Iran. [email protected] 3 . MD, General Physician, Tabriz University of Medical Sciences, Tabriz, Iran. [email protected] Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial Bina Eftekharsadat 1 , Arash Babaei-Ghazani* 2 , Vahideh Zeinolabedinzadeh 3 Received: 29 May 2015 Accepted: 18 May 2016 Published: 23 July 2016 Abstract Background: This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis. Methods: During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A case group treated with dry needling and a control group. Patients’ plantar pain severity, (using modified visual analog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar exten- sion [ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed at baseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test, Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis. Results: The mean VAS scores in the case group was significantly lower than the control group after four weeks of intervention (p<0.001). Comparison of the ROMDF and ROMPE did not reveal any significant chang- es after four weeks of intervention in the case and control groups (p=0.7 and p=0.65, respectively). The mean of MDC7 and SEM5 scores in the case group were significantly lower than the control group following four weeks of intervention (p<0.001). Conclusion: Despite the insignificant effect on ROMDF and ROMPE, trigger point dry needling, by improv- ing the severity of heel pain, can be used as a good alternative option before proceeding to more invasive thera- pies of plantar fasciitis. Keywords: Plantar fasciitis, Myofascial trigger points, Chronic heel pain, Dry needling. Cite this article as: Eftekharsadat B, Babaei-Ghazani A, Zeinolabedinzadeh V. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial. Med J Islam Repub Iran 2016 (23 July). Vol. 30:401. Introduction Heel pain due to plantar fasciitis is char- acterized by pain and tenderness centered under the medial tubercle of the calcaneus on weight-bearing surface, specifically immediately after rest such as getting out of bed in the morning (1). It is one of the most common foot disorders encountered by foot and ankle specialists that affects about 10% of people in their life, and it is responsible for approximately one million physician visits annually (2). Despite the high prevalence of plantar fasciitis and its detrimental impact on qual- ity of life (2-4), the optimal treatment for this disorder is still unclear (5). Numerous conventional treatments are currently used to treat plantar fasciitis including calf stretching, foot taping, manual therapy (joint mobilization and manipulation; mo- bilization of soft tissue near sites of nerve entrapment and passive neural mobilization techniques), foot orthosis, oral and injecta- ble anti-inflammatories, and night splints (5,6). Surgery is recommended as a last op- tion and is usually done after failure of at least six months of conservative therapy (7). However, these modalities may be as- sociated with serious side effects (8), and challenges toward an alternative adjunctive treatment are thus demanded. Acupuncture and dry needling are increasingly being Downloaded from mjiri.iums.ac.ir at 11:15 IRDT on Tuesday July 10th 2018

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Original Articlehttp://mjiri.iums.ac.ir Medical Journal of the Islamic Republic of Iran (MJIRI)

Iran University of Medical Sciences

____________________________________________________________________________________________________________________1. MD, Associate Professor, Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, [email protected]. (Corresponding author) MD, Assistant Professor, Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilita-tion, Iran University of Medical Sciences, Tehran, Iran. [email protected]. MD, General Physician, Tabriz University of Medical Sciences, Tabriz, Iran. [email protected]

Dry needling in patients with chronic heel pain due to plantarfasciitis: A single-blinded randomized clinical trial

Bina Eftekharsadat1, Arash Babaei-Ghazani*2, Vahideh Zeinolabedinzadeh3

Received: 29 May 2015 Accepted: 18 May 2016 Published: 23 July 2016

AbstractBackground: This study examined the effects of dry needling on chronic heel pain due to plantar fasciitis.Methods: During this single-blinded clinical trial, 20 eligible patients were randomized into two groups: A

case group treated with dry needling and a control group. Patients’ plantar pain severity, (using modified visualanalog scale [VAS] scoring system), range of motion of ankle joint in dorsiflexion [ROMDF] and plantar exten-sion [ROMPE] and foot function index (using standard questionnaires of SEM5 and MDC7) were assessed atbaseline, four weeks after intervention and four weeks after withdrawing treatment. Independent sample t-test,Mann-Whitney U test, paired t-test, Wilcoxon signed rank tests, and chi square test were used for data analysis.

Results: The mean VAS scores in the case group was significantly lower than the control group after fourweeks of intervention (p<0.001). Comparison of the ROMDF and ROMPE did not reveal any significant chang-es after four weeks of intervention in the case and control groups (p=0.7 and p=0.65, respectively). The mean ofMDC7 and SEM5 scores in the case group were significantly lower than the control group following four weeksof intervention (p<0.001).

Conclusion: Despite the insignificant effect on ROMDF and ROMPE, trigger point dry needling, by improv-ing the severity of heel pain, can be used as a good alternative option before proceeding to more invasive thera-pies of plantar fasciitis.

Keywords: Plantar fasciitis, Myofascial trigger points, Chronic heel pain, Dry needling.

Cite this article as: Eftekharsadat B, Babaei-Ghazani A, Zeinolabedinzadeh V. Dry needling in patients with chronic heel pain due toplantar fasciitis: A single-blinded randomized clinical trial. Med J Islam Repub Iran 2016 (23 July). Vol. 30:401.

IntroductionHeel pain due to plantar fasciitis is char-

acterized by pain and tenderness centeredunder the medial tubercle of the calcaneuson weight-bearing surface, specificallyimmediately after rest such as getting outof bed in the morning (1). It is one of themost common foot disorders encounteredby foot and ankle specialists that affectsabout 10% of people in their life, and it isresponsible for approximately one millionphysician visits annually (2).

Despite the high prevalence of plantarfasciitis and its detrimental impact on qual-ity of life (2-4), the optimal treatment forthis disorder is still unclear (5). Numerous

conventional treatments are currently usedto treat plantar fasciitis including calfstretching, foot taping, manual therapy(joint mobilization and manipulation; mo-bilization of soft tissue near sites of nerveentrapment and passive neural mobilizationtechniques), foot orthosis, oral and injecta-ble anti-inflammatories, and night splints(5,6). Surgery is recommended as a last op-tion and is usually done after failure of atleast six months of conservative therapy(7). However, these modalities may be as-sociated with serious side effects (8), andchallenges toward an alternative adjunctivetreatment are thus demanded. Acupunctureand dry needling are increasingly being

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used to treat heel pain, as many other mus-culoskeletal pain conditions (9,10).

Dry needling and acupuncture as alterna-tive and less invasive procedures, stimulatemyofascial trigger points [MTPs] (11-13).Dry needling has been shown to alter thebiochemical environment surrounding aMTP and reduce spontaneous electrical ac-tivity within the MTP region of skeletalmuscle (14,15). This method is one of themost popular modalities with minimal sideeffects used for treating chronic pains.There are a few published studies (16-19)with some methodological limitations,which have examined the effectiveness oftrigger point needling in relieving plantarheel pain. In addition, based on the currentreporting standards (20), the mentionedstudies lack a scientific rigor for outcomemeasurement and study design, and one ofthe studies is a case report. We concludedthat conducting further research is neces-sary to establish the efficacy of dry nee-dling for heel pain.

This study was conducted to examine theeffects of dry needling in patients withchronic heel pain due to the plantar fasciit-is.

MethodsDuring this single-blinded randomized

clinical trial, 20 consecutive patients whoreferred to the Physical Medicine and Re-habilitation Outpatient Clinic of ShohadaHospital of Tabriz were enrolled fromMarch 2010 to February 2011.

Informed written consent was obtainedfrom all the participants, and the EthicsCommittee of Tabriz University of Medi-cal Sciences (TUMS) approved the studyprotocol, which was in compliance withHelsinki declaration. The trial was regis-tered in the Iranian Clinical Trial Registrywith the identification number of 201106104641N4.

Patients who met the following criteriawere included in the study (10,21,22):Those older than 18 years; patients withthe ability to understand the instructions orcomplete the questionnaires; diagnosis of

plantar heel pain using the clinical guide-lines linked to the International Classifica-tion of Function, Disability and Healthfrom the Orthopedic Section of the Ameri-can Physical Therapy Association (5); ex-periencing pain for more than one month;having a heel pain on the first step duringthe last week with the rate of at least 40mm on visual analogue scale; attending thePhysical Medicine and Rehabilitation Out-patient Clinic of Shohada Hospital of Ta-briz for initial assessment and being ran-domly assigned into one of the studygroups; accepting to discontinue analge-sics, non-steroidal anti-inflammatory med-ications and oral/topical paracetamol for atleast 14 days prior to the initial evaluationand during the study period (four weeksafter the final treatment); walking 50 me-ters without any support; having MTPs oninitial physical examination on plantar andcalf muscles; and absence of Raynaud'sdisease.

Exclusion criteria of the study were asfollows: Refuse needling and routinephysical therapy (e.g., cooling, stretch,massage therapy and/or footwear modifica-tions),; diagnosis of coagulopathy or takinganticoagulants except for acetylsalicylicacid at dosages up to 325 mg/day; preg-nancy; dermatological disease in the areaof needling; previous history of dry nee-dling or acupuncture; treatment for plantarheel pain within four weeks prior to thestudy; inability to understand the instruc-tions or complete the questionnaires; pres-ence of peripheral arterial vascular disease;history of connective tissue disease; pres-ence of a chronic medical condition likerheumatoid arthritis, psoriatic arthritis, an-kylosing spondylitis, septic arthritis, neuro-logical abnormalities, sciatica, and/orchronic pain; history of plantar fascia sur-gery; history of injection therapy in theheel during the previous three months; andknown hypersensitivity to metals (10,21,22).

Twenty eligible patients were random-ized using closed mail pockets containingA or B letters into two study groups: The

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case group received dry needling but thecontrol group did not. All the participantswere trained for plantar muscles calf mas-sage and stretching at home. Plantar mas-sage was done with a cold can under thefoot with the patient rolling his/her foot onthe can with pressure; and calf musclemassage was done with the patient crossinghis/her foot on the other and pressuring itby thumb and index fingers massaging themuscle. In addition, 50 mg diclofenac so-dium per 12 hours and orthostatic plantarpad were administered for all patients.

In addition to the routine treatments, thecase group received dry needling of MTPsone session per week (10,18) for four con-secutive weeks. Diagnosis of MTPs wasbased on detecting a tender spot or nodulein a taut band of skeletal muscle. Dry nee-dling was based on calf muscles triggerpoints, especially four trigger points ofgastrocnemius muscle (Fig. 1) and suchdecisions were made by one physical med-icine and rehabilitation specialist with fiveyears of experience in this field (23). In thecontext of this study, dry needling involvedthe stimulation of MTPs, using a dry nee-dle with the length of 30-50mm and diame-ter of 0.6mm. Treatment was conductedwithin a 30-minute timeframe. The partici-pants were lying flat, and following the in-

sertion, the needle was partially withdrawnand advanced repeatedly to produce an ap-propriate response. If the participant weresensitive to insertion of the needle, the ma-nipulation would be reduced. If this actionwas insufficient to reduce the painful stim-ulus, the manipulation would be ceasedand the needle left in situ. The needle wasleft in the muscle for as long as it wasneeded to produce an appropriate responseand was being tolerated by the participant.Appropriate response was based on twitchresponse, in which needle movements wererepeated until the twitch response of themuscle was disappeared. Once this has oc-curred, the needle was left in the situ forfive minutes. This allowed sufficient timefor the stimulus to subside in sensitive par-ticipants.

The effects of dry needling were evaluat-ed at three time points of baseline, fourweeks after intervention and four weeksafter withdrawing treatment. Figure 2demonstrates the study flow diagram.

The severity of pain was measured usinga modified visual analog scale [VAS] scor-ing method ranging from none to an ex-treme amount of pain (24). Operationally, aVAS is usually a horizontal line with 100mm length, anchored by word descriptorsat each end as illustrated in Figure 3. Thepatients mark a point on the line that theyfeel represents their perception of their cur-rent state, and then the VAS score is de-termined by measuring, in millimeters, theleft hand end of the line to the point thatthe patient had marked. Patients’ plantarpain severity was assessed using VAS atbaseline, four weeks after intervention andfour weeks after withdrawing treatment.

Range of motion of ankle joint in dorsi-flexion (ROMDF) and plantar extension(ROMPE) was measured at baseline, fourweeks after intervention and four weeksafter withdrawing treatment.

Foot function index [FFI] was studied us-ing a validated questionnaire developed tomeasure the impact of foot pathology onfunction in terms of pain, disability and ac-tivity restriction. The questionnaire gave

Fig. 1. Illustration of Four Myofascial TriggerPoints (MTPs) of Gastrocnemius Muscle

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the scores of 7 (MDC7) for minimal de-tectable changes and 5 for standard errormeasurement (SEM5). Pain was evaluatedin five items, and disability and activity re-striction were scored by nine and threeitems, respectively (25,26). Statisticallysignificant decrement in VAS and otheroutcome measurements was considered aseffectiveness in the two groups.

Statistical analyses were performed usingSPSS 13. The results are shown as mean ±

standard deviation, The Kolmogorov-Smirnov test was used to check the nor-mality. Independent sample t-test or Mann-Whitney U test, paired t-test or Wilcoxonsigned rank tests, and chi square test wereutilized to assess the differences betweenthe stages. A p value of less than 0.05 wasconsidered significant.

ResultsDemographic characteristics of the pa-

Fig. 2. A Flow Diagram of the Study Protocol

Fig. 3. Illustration of Visual Analog Scale, VAS (The VAS is usually a horizontal line with 10 cm length)

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tients in both groups are listed in Table 1.Male to female ratio was 3 to 7 in casesand 4 to 6 in controls (Chi Square, p<0.05).No significant difference was detected be-tween the cases and controls in the meanage, sex distribution and number of triggerpoints. There was not any drop out or lossto follow up during the study.

Intragroup Findings in the Case Groupafter Intervention

Based on paired t-test, the mean VASscores was significantly decreased afterfour weeks of intervention (p<0.001) andfour weeks of cessation period (p<0.001).The mean ROMDF of ankle joint was sig-nificantly increased both after four weeksof intervention (p<0.001) and four weeksof cessation period (p<0.001). Althoughthe change in ROMPE of ankle joint wasnot significant after four weeks of interven-tion (p=0.34), the mean ROMPE of anklejoint was significantly increased after fourweeks of cessation period (p<0.04).

Based on the Wilcoxon test, the mean ofMDC7 and SEM5 scores were significant-ly decreased after four weeks of interven-tion (P<0.001). No significant changeswere found in the mean of MDC7 and

SEM5 scores (p>0.05) after four weeks ofcessation period, but they were lower thanbaseline scores (p<0.001).

Intragroup Findings in the ControlGroup after Intervention

Based on the paired t-test, the mean VASscores was significantly decreased afterfour weeks of intervention (p=0.002) andfour weeks of cessation period (p<0.001).

The mean ROMDF of ankle joint wassignificantly increased both after fourweeks of intervention (p=0.01) and fourweeks of cessation period (p<0.001). Thechange in ROMPE of ankle joint was notsignificant after four weeks of intervention(p=0.18), but the mean ROMPE of anklejoint significantly increased after fourweeks of cessation period (p<0.03).

Based on the Wilcoxon test, the mean ofMDC7 and SEM5 scores were significant-ly decreased after four weeks of interven-tion (p<0.001). No significant changeswere observed in the mean of MDC7 andSEM5 scores (p>0.05) following fourweeks of cessation period, but they werelower than baseline scores (p<0.001).

Table 1. Demographic Characteristics, VAS Scores, SEM5, MDC7, Ankle joint's ROMDF and ROMPEof the Patients in the Two Groups

Case groupMean±SD

Control groupMean±SD

p

Age (Year) 50.3±9.0 50.9±8.9 0.88Trigger point (No) 1 ------- ------- 1

2 2 (20%) 2 (20%)3 5 (50%) 5 (50%)4 3(30%) 3(30%)

VAS A 8.2±0.7 7.6±0.9 0.14B 2.6±1.5 6.6±1.2 <0.01C 3.0±1.2 3.5±1.3 0.36

SEM5, MDC7 A 61.0±10.3 50.9±14.0 0.08*B 25.9±7.8 43.2±13.3 0.003*C 27.3±6.6 26.1±10.7 0.81*

Ankle ROMDF (degree) A 11.9±3.4 6.3±4.8 0.008*B 14.5±4.3 9.1±5.3 0.02*C 17.5±3.5 15.8±5.3 0.44*

Ankle ROMPE (degree) A 21±5.6 26.2±4.7 0.03*B 21.5±6.2 26.6±4.3 0.05*C 24±6.1 28.3±5.5 0.12*

VAS: Visual analog scale; ROMDF: Range of motion in dorsiflexion; ROMPE: Range of motion in plantar extension;SEM5: Standard error measurement 5; MDC7: Minimal detectable changes 7; A: Baseline; B: Four weeks after interven-tion; C: Four weeks after withdrawing treatment; * independent or Man Whitney U test was used accordingly

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Comparison of the Case and ControlGroups

Independent t-test revealed that the meanVAS scores in the case group was signifi-cantly lower than the control group afterfour weeks of intervention (p<0.001).

Comparison of the ROMDF and ROMPEof ankle joint did not reveal any significantdifferences between the case and controlgroups after four weeks of intervention(p=0.7 and p=0.65, respectively).

Based on the Mann-Whitney U test, themean of MDC7 and SEM5 scores in thecase group was significantly lower than thecontrol group (p<0.001) following fourweeks intervention.

DiscussionTreatment options for plantar fasciitis can

be divided into conservative and surgicalmeasures. There is a professional consen-sus that 70–90% of heel pain patients canbe managed by non-surgical modalities(27). Although a variety of treatment op-tions are available for pain reduction andimproving joint range of motion in patientswith plantar fasciitis, there is little convinc-ing evidence to support these varioustreatments (28,29).

In recent years, dry needling and/or injec-tion of therapeutic medications (local anes-thetics, steroids, botulinum toxin A) havebeen studied for plantar fasciitis treatment.Of these treatment options, steroid injec-tions are more commonly used in treatingacute and chronic plantar fasciitis, espe-cially when more conservative manage-ments are unsuccessful. Randomized con-trolled trials have shown that this methodhas some short-term benefits (6). A pro-spective randomized study that evaluated avariety of treatments including autologousblood injection, lidocaine needling, tri-amcinolone injection, and triamcinoloneneedling, reported superior results in tri-amcinolone group (30). Possible risks as-sociated with corticosteroid injection in-clude fat pad atrophy and plantar fasciarupture (22). A quasi-experimental trial us-ing 1% lidocaine injections of MTPs has

found a reduction in pain when combinedwith physical therapy (31). Moreover, fewstudies have found that Botulinum toxin Ainjection resulted in significant pain im-provement in short and long terms (32).

Physical medicine and rehabilitation spe-cialists increasingly use dry needling,which involves stimulation of MTPs, as analternative treatment option for musculo-skeletal pain. Myofascial trigger point(MTP) is a hyperirritable spot in skeletalmuscle tissue, and it is associated with ahypersensitive palpable nodule in a tautband and may result in characteristic ten-derness, referred pain, motor dysfunctionand even autonomic phenomena. There isno clear guideline to use dry needling forplantar fasciitis (10).

Collectively, this study revealed that de-spite ineffectiveness in the range of motionof the ankle joint, dry needling improvedthe severity of pain, evaluated by VAS,MDC7 and SEM5 measurements.

A meta-analysis of randomized con-trolled trials (33) found that dry needlingand acupuncture of MTPs was not signifi-cantly superior to placebo in treating mus-culoskeletal pains. However, this study justincluded four trials sand it suffers fromlimited sample size, poor quality and therewas a marked statistical heterogeneity in itsdata pool, which precludes making defini-tive conclusions.

Only a few studies were conducted on theeffectiveness of dry needling in plantarheel pain treatment (34). Also, due to theuncertainty about the relationship betweenneedling of traditional acupuncture pointsand MTPs (35), only four published quasi-experimental trials (16-19) have investigat-ed the effectiveness of trigger points nee-dling in relieving plantar heel pain.

One study (16) evaluated the effective-ness of a four-week (one treatment perweek) period of acupuncture followed bytwo weeks of acupuncture combined withtrigger points needling of the calf and heelregions. This study reported a significantimprovement in plantar heel pain, as meas-ured on a VAS. Another study (17) studied

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the outcome of trigger points dry needlingcombined with electro-acupuncture, anddemonstrated a significant reduction inpain with a six-week (one treatment perweek) plan of acupuncture in combinationwith dry needling of the heel and arch.Cotchett et al. (18) investigated a six-week(one treatment per week) period of dryneedling and evaluated VAS and the painsubscale of Foot Health Status Question-naire. They found a statistically significantimprovement in plantar heel pain, butwarned about some adverse transitory ef-fects. Akhbari et al. published a case reportof plantar fasciitis treated with two-week(one treatment per week) period of dryneedling with acupuncture needles and re-ported 60 to 70% pain reduction. In con-trast to our study, most of these studieswere limited by some methodologicalproblems, which reduced their quality. Oneof these studies was a case report with onlyone patient treated with dry needling. Im-portantly, most of these studies did not in-clude a control in their trials to comparethe intervention and non-intervention ef-fects. Lack of a control group makes it dif-ficult to precisely analyze the absolute ef-fect of needling, and particularly one can-not clarify the influence of the naturalcourse of the disorder from the interven-tion. In addition, combining acupuncturewith dry needling of MTPs made it diffi-cult to isolate the effectiveness of eachtechnique separately. In addition, the ab-sence of clear data on the criteria used todiagnose MTPs, and different methods ap-plied by authors were another importantlimitation of the previous studies. Becauseof significant variability of criteria foridentifying MTPs (36), it should be out-lined by researchers.

This study has its own limitations. Alt-hough the power calculation of 0.80 wasdone for this study, the major limitationcould be the small sample size. Carryingmulticenter and multiethnic study withlarge sample size would be very helpful indetermining eventual results of dry nee-dling. In this study, we just tried to show

the independent short-term effect of dryneedling. Further, performing routine ther-apies on all patients did not allow evaluat-ing sole effects of this therapeutic approachon heel dynamics.

In conclusion, this study revealed thattrigger point dry needling by improving theseverity of heel pain, can be used as a goodalternative option before proceeding tomore invasive therapies of plantar fasciitisdespite its insignificant effect on the rangeof motion of the ankle joint.

Conflict of interestThe authors have no financial interests to

disclose in relation to the content of thisarticle.

Ethical ApprovalThe study protocol was approved by the

Ethics Committee of Tabriz University ofMedical Sciences (TUMS), which is incompliance with Helsinki declaration. Thetrial was registered in the Iranian "Clinicaltrial Registry" with identification numberof "201106104641N4".

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