low back pain: broad principles of the patient pathway

31
Commissioning guide 2013 Low Back Pain 2013 Commissioning guide: Low Back Pain: Broad Principles of the patient pathway Version 1.1: This updated version has been published in June 2014 and takes account of NICE documents published since the original literature review was undertaken as well as further input from a pain medicine perspective. Sponsoring Organisation: United Kingdom Spine Societies Board (UKSSB) British Orthopaedic Association (BOA), Royal College of Surgeons for England (RCSEng) Date of evidence search: August 2012 Date of publication: November 2013 Date of Review: November 2016 NICE has accredited the process used by Surgical Speciality Associations and Royal College of Surgeons to produce its Commissioning guidance. Accreditation is valid for 5 years from September 2012. More information on accreditation can be viewed at www.nice.org.uk/accreditation

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Page 1: Low Back Pain: Broad Principles of the patient pathway

Commissioning guide 2013 Low Back Pain

2013

Commissioning guide:

Low Back Pain: Broad Principles of the

patient pathway

Version 1.1: This updated version has been published in June 2014 and takes account of NICE documents

published since the original literature review was undertaken as well as further input from a pain medicine

perspective.

Sponsoring Organisation: United Kingdom Spine Societies Board (UKSSB)

British Orthopaedic Association (BOA), Royal College of Surgeons for England (RCSEng)

Date of evidence search: August 2012

Date of publication: November 2013

Date of Review: November 2016

NICE has accredited the process used by Surgical Speciality Associations and Royal College of Surgeons to produce its Commissioning guidance. Accreditation is valid for 5 years from September 2012. More information on accreditation can be viewed at www.nice.org.uk/accreditation

Page 2: Low Back Pain: Broad Principles of the patient pathway

Commissioning guide 2013 Low Back Pain

CONTENTS

Introduction ............................................................................................................................................... 1

1 High Value Care Pathway for Low Back Pain ........................................................................................ 2

1.1 Primary Care……………………………………………………………………………………………………………………………………………2

1.2 Intermediate Care……………………………………………………………………………………………………………………………………4

1.3 Secondary Care……………………………………………………………………………………………………………………………………….4

2 Procedures explorer for Low Back Pain ................................................................................................ 6

3 Quality dashboard for low back pain ................................................................................................... 7

4 Levers for implementation .................................................................................................................. 8

4.1 Audit and peer review measures ……………………………………………………………………………………………………………8

4.2 Quality Specification/CQUIN (Commissioning for Quality and Innovation)……………………………………………10

5 Directory .......................................................................................................................................... 12

5.1 Patient Information for low back pain……………………………………………………………………………………………………12

5.2 Clinician information for low back pain………………………………………………………………………………………………… 12

6 Benefits and risks .............................................................................................................................. 13

7 Further information .......................................................................................................................... 14

7.1 Research recommendations………………………………………………………………………………………………………………….14

7.2 Other recommendations……………………………………………………………………………………………………………………….14

7.3 Evidence base……………………………………………………………………………………………………………………………………… 14

7.4 Guide development group for low back pain…………………………………………………………………………………………15

7.5 Funding statement ……………………………………………………………………………………………………………………………….17

7.6 Methods statement ……………………………………………………………………………………………………………………………..17

7.7 Conflicts of Interest Statement …………………………………………………………………………………………………………….17

The Royal College of Surgeons of England, 35-43 Lincoln’s Inn Fields, London WC2A 3PE..

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Introduction

This guidance is for commissioners and it gives broad principles of the patient pathway. It should be read in

conjunction with the High Value Care Pathway for Radicular Pain (under review). Details of commissioning

specific parts of the pathway will vary with local circumstances. This document is not a clinical guideline and

includes acute (lasting up to 6 weeks) and chronic (lasting more than 6 weeks) low back pain.

While reference is made to NICE guidance CG88 it is acknowledged that the current guidance is under review

by NICE with a more inclusive scope.

Low back pain without radicular pain is one of the most common musculo-skeletal conditions presenting to

GPs. Access rates have increased from 231 to 295 per 1,000 from 2005 to 2010 indicating a significant rise.

There were over 70,000 procedures for low back pain in England in 2010/11 (HES data), with around 67,000

of these being facet joint injections (OPCS code V544).1

Treatment should be aimed at allowing patients to remain independent and return to previous activities and

employment in the shortest time possible.

Patients with acute low back pain should self-manage with simple analgesia and minimal bed rest, up to a

maximum of 48 hours depending on the severity of pain followed by progressive resumption of their normal

activity. The vast majority of patients with low back pain will improve naturally assisted by good primary care

management including physiotherapy/ hands on manipulation.1

For those that do not respond, an early risk assessment should be conducted in primary care and they should

be actively managed by the appropriate therapists.

Cost effective care results in an early return to work and reduces unnecessary attendance at Emergency

Departments and General Practitioners.

Lumbar facet joint injections should not be routinely considered for patients with low back pain of up to 12

months duration.2-5 Lumbar facet joint nerve blocks may be considered for those who are being considered

for radiofrequency denervation AND are being managed by a multidisciplinary team (MDT) which includes

the chronic pain service.2

This pathway is a guide which can be modified according to the needs of the local health economy.

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1 High Value Care Pathway for Low Back Pain

1.1 Primary Care

This is a guide for commissioners of clinical services and not a clinical tool. Clinical pathways include the Map

of Medicine Pathway (http://bps.mapofmedicine.com/evidence/bps/low_back_and_radicular_pain1.html)

and the Spinal Pathfinder Project (in development).

See diagram of the full clinical pathway in Appendix 1

PRIMARY CARE

Assessment:

history – ask about previous history, local/referred leg pain, radicular pain, bladder/bowel/sexual

dysfunction, systemic symptoms, Yellow Flags (see Appendix 2)

examination – look for neurological signs and postural changes

do not request plain X-rays or MRI scans at this stage

the GP may use the STarT Back Tool6 7 at this stage available at http://www.keele.ac.uk/sbst/

Emergency referral to Spinal Surgeon (same day):

possible unstable fracture: severe low back pain after history of significant trauma

Cauda Equina Syndrome: bladder/bowel/sexual dysfunction/loss or altered sensation wiping

bottom (saddle anaesthesia)

acute spinal cord compression: new/progressive neurological deficit (consider any previous history of

cancer)

Urgent referral to Spinal Surgeon (<2 weeks): (Red Flags, see Appendix 2)

spinal metastases: history of cancer e.g., lung, breast, prostate, unexplained weight loss, progressive

non mechanical back pain, thoracic back pain. Recent guidance (NICE quality standard 56,

www.nice.org.uk/guidance/QS56) suggests these patients have an MRI scan of the whole spine and

treatment plan agreed within 1 week of the suspected diagnosis

spinal infection: history of fever, IV drug use, recent infection, immunocompromised patients i.e.,

those on steroids, and those with diabetes

Fracture: history of sudden onset severe back pain with/without minor trauma, and/or recent onset

deformity where there is suspicion that there may be something other than a simple osteoporotic

fracture

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severe radicular pain: not responding to treatment after 6-8 weeks

Routine referral to secondary care (4-6 weeks):

suspected rheumatological condition (refer to rheumatology): younger patient, prolonged early

morning stiffness, alternating buttock pain, symptoms improve with exercise, or systemic symptoms

e.g., uveitis, inflammatory bowel disease, psoriasis, (more urgent referral may be needed for severe

symptoms)

spinal deformity detected clinically or radiologically (refer to spinal surgeon): severe low back pain

with spinal deformity including scoliosis or anterior sagittal imbalance (excluding suspected discogenic

pain with lateral shift)

High grade spondylolisthesis (grade 3,4,5) confirmed on radiograph

Osteoporotic vertebral/sacral fracture remaining painful after 6-8 weeks. Most osteoporotic fractures

should be initially managed with adequate analgesia and DEXA scan (unless the patient is already on

treatment for osteoporosis)

Management:

risk assessment using STarT6 Back tool: http://www.keele.ac.uk/sbst/

reassurance, encouragement to stay active, early managed return to work

simple analgesia including weak opioids

strong opioids should not be recommended at all in the non-specialised setting unless for short-term

use with severe acute pain of 2 weeks duration. The principles of managing ongoing analgesic therapy

include the 4‘A’s: Analgesia, adverse effects, activity, and adherence.

provide patient information for education, reassurance and to allow shared decision making

IF low risk

referral to GP practice physiotherapy for one 30 minute session

allow self-referral for one session of therapy and advice (this may be through a musculoskeletal or

spinal triage service).

IF medium risk (and low risk non responders)

refer for core therapies including (NICE CG88) manual therapy involving either exercise and/or

manipulation (including physiotherapists, chiropractors, osteopaths) and/or acupuncture and/or

provision of educational material

these typically involve 5-10 sessions over 6-12 weeks.

IF high risk

should be referred to a low intensity CPPP Programme usually uni-disciplinary (physiotherapy), but

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with links to psychology services8,9.

If symptoms still significant, despite the above management, refer to intermediate care.

1.2 Intermediate Care1

In acute low back pain, a decision can be made for an early review at 2 weeks before active management.

Assessment

review and assess improvement

refer if emergency/urgent/routine referral criteria

routine referral to a spinal surgeon if suspected spondylolisthesis or spondylolysis i.e,. young

sportsperson

inadequate improvement

Management

refer for high intensity CPPP (Combined Physical and Psychological Programme) likely to be different to

the service providing low intensity

this is up to 100 hours of group treatment with high intensity CPPP over a period of up to 8 weeks but

often delivered on a full-time basis over 2-3 weeks (NICE CG88)

the format of high intensity CPPP varies widely and may operate as pain management, functional

restoration, or ‘Return to Work’ programmes

these programmes may be available in primary, intermediate or secondary care

Referral to secondary care or MDT

failure to respond to high intensity CPPP (or other therapy if no high intensity CPPP available)

timing of MRI scan, spinal surgeon review and pain clinic involvement to be organised locally, but a spinal

surgeon should be involved in the decision making at this stage

1.3 Secondary Care

Whilst few patients will need referral to secondary care, this is a high value part of the pathway hence the

detail.

Assessment

patients should be assessed by a multi-disciplinary team (MDT) that is part of a spinal network including:

1 Those services that do not require the resources of a general hospital, but are beyond the scope of the traditional

primary care team (René JFM, Marcel GMOR, Stuart GP, et al. What is intermediate care? BMJ 2004;329(7462):360-61)

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spinal surgeons, interventional radiologists, pain specialists, physiotherapists, clinical psychologists,

rheumatologists and extended scope practitioners

history and examination: see Assessment

MRI scanning same day for emergency referral and within one week for urgent referrals

Injections

Facet joint injection/medial branch block/radiofrequency denervation:

injections should not be used for patients with low back pain of less than 12 months duration, or

moderate to severe depression

all injections should be carried out under radiological control

for those with low back pain of more than 12 months who have failed other treatment options (above),

injections may be considered within a multidisciplinary team (MDT) approach to pain management usually

involving a pain clinic

there is no evidence for the use of facet joint or medial branch injections in predicting the outcome of

spinal fusion surgery

however, while there is limited evidence for facet joint injections, there is fair to good evidence that

medial branch blocks (also OPCS code V544) may be effective for the treatment of chronic lumbar facet

joint pain resulting in short-term and long-term pain relief and functional improvement2.

radiofrequency denervation of lumbar facet joints should only be undertaken after a successful lumbar

medial branch block and as part of a MDT managed programme of care

epidural injections either sacral or interlaminar and nerve root injections are not of value for patients with

non-specific low back pain

Pain management

those who fail to respond to surgery will continue under the care of their spinal MDT and pain

management service; more complex pain management services such as spinal cord stimulation,

peripheral nerve-field stimulation or intra-thecal drug delivery systems may require onward referral to

a specialised pain management service including neurosurgery as defined by NHS England

pain management services as part of a complex care package will also be required for those who have

non-resolving LBP despite appropriate conservative treatment i.e., a high intensity CPPP and for those

patients who are not suitable for or do not wish to undergo spinal surgery

patients who have severe ongoing pain after a recent unhealed vertebral fracture despite optimal pain

management and in whom the pain has been confirmed to be at the level of the fracture by physical

examination and imaging may be considered for percutaneous vertebroplasty and/or percutaneous

balloon kyphoplasty without stenting

Surgery

Patients should be informed that the decision to have surgery can be a dynamic process and a decision to not

undergo surgery does not exclude them from having surgery at a future time point.

identify and manage “Yellow Flags”, if not already identified, as their presence may rule out surgery

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surgery may be required in those patients with low back pain secondary to deformity, tumour, trauma

and infection

for those patients where no other cause can be found and where a high intensity CPPP has failed to

produce significant improvement, surgery may be considered

patients with 1 or 2 levels of degenerative change may be suitable for spinal fusion (anterior,

posterior, anterior and posterior)

primary or revision of one or two level posterior instrumented fusions are considered non-specialised

and are funded by Clinical Commissioning Groups

1.4 Secondary Care: Specialised Surgery

Specialised surgery

more than two level posterior and/or anterior surgery is considered specialised surgery and is

commissioned by NHS England

lumbar disc replacement may be considered an alternative for spinal fusion but should be

commissioned with prudence from Specialist Spinal Centres and is ‘specialised’ surgery which should

be commissioned by NHS England

2 Procedures explorer for Low Back Pain

Users can access further procedure information based on the data available in the quality dashboard to see

how individual providers are performing against the indicators. This will enable CCGs to start a conversation

with providers who appear to be 'outliers' from the indicators of quality that have been selected.

The Procedures Explorer Tool is available via the Royal College of Surgeons website.

The Procedures Explorer for treatment of low back pain describes variation in:

Procedure OPCS4 codes Exclusions

Facet joint

injection/medial branch

block

V544 Appendix 5

Radiofrequency

denervation lumbar facet

joint

V485, V486, V487, V488, V489 Appendix 5

Posterior lumbar spinal

fusion

V382-6, V388, V404 Appendix 5

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Lumbar disc replacement V363*

Anterior lumbar spinal

fusion

V333-6*

Revision lumbar fusion V343-6*, V393-7 Appendix 5

All procedures in the above table should be accompanied by a V55 code to determine number of levels: V551 = 1 level, V552 = 2 levels; V553 = >2levels

*Commissioned by NHS England. All procedures accompanied with V553 to indicate more than 2 levels are also commissioned by the NHS England (except injections).

3 Quality dashboard for low back pain

The quality dashboard provides an overview of activity commissioned by CCGs from the relevant pathways,

and indicators of the quality of care provided by surgical units.

The quality dashboard is available via the Royal College of Surgeons website.

For the current dashboard indicators (see Appendix 4)

Measure Definition Data Source

Standardised activity rate Activity rate standardised for age

and sex

HES/Quality Dashboard

(Appendix 4)

Average length of stay Total spell duration/total number of

patients discharged

HES/Quality Dashboard

(Appendix 4)

Day case rate Number of patients admitted and

discharged on the same day/total

number of patients discharged

HES/Quality Dashboard

(Appendix 4)

Short stay rate Number of patients admitted and

discharged within 48 hours/total

number of patients discharged

HES/Quality Dashboard

(Appendix 4)

7/30 day readmission rate Number of patients readmitted as

an emergency within 7/30 days of

discharge/total number of patients

discharged excludes cancer,

dementia, mental health

HES/Quality Dashboard

(Appendix 4)

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Re-operations within 30

days/1 year

Number of patients re-operated

during an emergency readmission

within 30 days/ 1 year/total number

of patients discharged

HES/Quality Dashboard

(Appendix 4)

In hospital mortality rate Number of patients who die while in

hospital /total number of patients

discharged

HES/Quality Dashboard

(Appendix 4)

Areas for development of dashboard in future

Measure Evidence Base Data Source*

Time off work GP Data

*includes data from HES, National Clinical Audits, Registries

4 Levers for implementation

4.1 Audit and peer review measures

Levers for Implementation are tools for commissioners and providers to aid implementation of high value

care pathways.

Measure Standard Where data should be obtained from:

Missed Red Flags in

primary care

Secondary care providers should report

annually the number of cases where

there has been a significant delay in

referral for patients with red flags

including: the red flag, length of delay,

pathology

Use of STarT Back

Tool

Use the two subscales of

the STarT Back Tool

CCGs should report the percentage of

GPs using the STarT Back Tool

Establish back pain service in primary or secondary care offering assessment, low intensity CPPP and access to imaging including MRI and reporting to the spinal MDT

A spinal assessment service

should be developed to

assess all spinal referrals

unless emergency or urgent

referral is required. Imaging

investigations should be

requested as required and a

regular MDT set up to

discuss cases for referral.

The service should report:

1. Number of patients seen 2. Number of patients referred for low

intensity CPPP 3. Number patients referred for high

intensity CPPP 4. Number of MRI scans performed 5. Number of patients referred to spinal

MDT 6. Number of patients referred to spinal

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This service should

be established for

back pain (cervical,

thoracic and lumbar)

and radicular pain

(cervical and lumbar)

This should have strong

links with the spinal surgery

network

surgeon 7. Number of patients referred to pain

management

Access to CPPP Each CCG should have

access to low and high

intensity CPPP. These may

have different providers

The CPP service should report:

1. STarT Back score on referral 2. ODI and EQ-5D before and after

treatment 3. Return to work

Established

secondary care

spinal MDT meeting

Spinal Task Force

standards

Include all personnel

involved in the provision of

spinal services in a Trust.

Spinal Taskforce: guide for

commissioners

“Commissioning Spinal

Services”

http://www.nationalspinalt

askforce.co.uk/

Number of MDT meetings held

Number of patients discussed

Access to spinal

surgeons

Spinal surgeons able to perform the required surgery should be part of the regional spinal network as all cases for surgery should be discussed within the setting of a spinal MDT

All patients having surgical interventions

including injections should have

Patient Reported Outcome Measures

(PROMs) before surgery and at 1 and 2

years after surgery (6 months after

injections). These should include either:

o COMI (Core Outcome Measures Index) and EQ-5D or

o VAS back and leg, Oswestry Disability Index and EQ-5D. (This is now the international standard outcome measure set approved by ICHOM. COMI on its own does not meet all the requirements)

This data along with the surgical

procedure and any complications (see

Appendix 6) should be recorded in one

of the spinal databases

(British Spine Registry or Spine Tango –

see Appendix 7)

Analysis of this data will form part of revalidation for the surgeon

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Training and

governance of

community

providers and other

AQP

Community and AQP may provide: 1. Low intensity CPPP 2. High intensity CPPP 3. Non-specialised spinal

surgery 4. Pain management

services

Staff training, revalidation, indemnity, quality of service delivery and collection and reporting of outcome measures must be the same for all providers (see above)

Access to pain

services

Patients with low back pain may access pain services for: 1. high intensity CPPP, optimisation of pharmacotherapy or spinal injections 2. if unsuitable for spinal surgery (a decision which must be made by a spinal surgeon) or the patient does not want to consider surgery 3.after unsuccessful spinal surgery

All patients should have patient

reported outcome measures (PROMs)

on referral and on discharge.

These should include either:

o COMI (Core Outcome Measures Index) and EQ-5D or

o VAS back and leg, Oswestry Disability Index and EQ-5D (This is now the international standard outcome measure set approved by ICHOM. COMI on its own does not meet all the requirements)

4.2 Quality Specification/CQUIN (Commissioning for Quality and Innovation)

Measure Description Data specification

(if required)

Success of spinal

assessment service

This will inform outlier

identification and scrutiny

The service should report: 1. Number of patients seen 2. Number of patients

referred for low intensity CPPP

3. Number patients referred for high intensity CPPP

4. Number of MRI scans performed

5. Number of patients referred to spinal MDT

6. Number of patients referred to spinal surgeon

7. Number of patients referred to pain management

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Success of low intensity

CPPP

Measures to be reported by each

provider

The low intensity CPPP service should report: 1. STarT Back score on

referral 2. ODI and EQ-5D, VAS back

and VAS leg before and after treatment

3. Return to work Success of high intensity

CPPP

Measures to be reported by each

provider

The high intensity CPP service should report: 1. ODI and EQ-5D, VAS back

and VAS leg before and after treatment

2. Return to work Success of spinal injections

for back pain

Lumbar facet joint injections Medial branch block Lumbar facet joint radiofrequency

denervation

All patients having these injections should have patient reported outcome measures (PROMs) before and at 6 months after injection These should include either: o COMI (Core Outcome

Measures Index) and EQ-5D or

o VAS back and leg, Oswestry Disability Index and EQ-5D

This data along with the

surgical procedure and any

complications (see Appendix

6).

Success of spinal surgery Spinal surgery for back pain All patients having surgical interventions should have PROMS before surgery and at 1 and 2 years after surgery. These should include either: o COMI and EQ-5D o VAS back and leg,

Oswestry Disability Index and EQ-5D

This data along with the

surgical procedure and any

complications (see Appendix

6) should be recorded in one

of the spinal databases

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(British Spine Registry or

Spine Tango – see Appendix

7)

British Association of Spine

Surgeons audit of

suspected cauda equina

syndrome (CES)

All hospitals treating CES

should complete the audit

and submit data for central

reporting. The data can be

input directly into the British

Spine Registry (see Appendix

7)

5 Directory

5.1 Patient Information for low back pain

Name Publisher Link

Back Pain NHS Choices www.nhschoices.nhs.uk

Nonspecific low back pain

in adults

EMIS www.patient.co.uk

Back Pain Arthritis

Research UK

www.arthritisresearchuk.org

5.2 Clinician information for low back pain

Name Publisher Link

Sheffield Back Pain

Service

www.sheffieldbackpain.com

The Back Book Royal College of General

Practitioners

ISBN 0-11-702949-1

Low back pain and

sciatica

NHS Clinical Knowledge

Summaries

http://www.cks.nhs.uk/back_pain_low_and_sciatica

Back Care Back Pain Association www.backcare.org.uk

Red Flags (Appendix 2) British Pain Society 2012 www.sheffieldbackpain.com/professional-resources/learning/in-detail/red-flags-in-back-pain British Pain Society Spinal Pain Working Group consensus opinion (2012)

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www.britishpainsociety.org

Yellow Flags

(Appendix 2)

Royal College of

Anaesthetists

www.sheffieldbackpain.com/professional-

resources/learning/in-detail/yellow-flags-in-back-

pain

Nice Guidance CG88

Early Management of

Persistent Non-

Specific low back pain

NICE

www.nice.org.uk/cg88

NICE quality standard

56 Metastatic spinal

cord compression

NICE http://www.nice.org.uk/guidance/QS56

NICE interventional

procedure guidance

451 Peripheral nerve-

field stimulation for

chronic low back pain

NICE http://publications.nice.org.uk/peripheral-nerve-

field-stimulation-for-chronic-low-back-pain-ipg451

STarT back pain

screening tool

Keele University www.keele.ac.uk/sbst/ Hill et al 2011

Oswestry Disability

Index (ODI) v2.1a

MAPI Trust http://www.mapi-trust.org/

6 Benefits and risks

Benefits and risks of commissioning the pathway are described below.

Consideration Benefit Risk

Patient outcome Getting patients back to work Improved outcome Prevention of chronicity

Long term unemployment

Patient safety Avoiding use of addictive and morphine

based analgesia11-13

Illness behaviour with increased

demand on primary and

secondary care

Patient

experience

Early treatment and advice Patient participation

Equity of access Even geographical spread of services and excellent quality of service throughout England

Current service provision is sporadic Risk of chronicity and drug

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Reduce long-term morbidity dependency

Resource impact Reduced attendance at emergency department Reduced time off work Reduction in prescriptions Reduction in spinal injections Reduction in GP attendances Reduction in drugs prescribed and investigations done Improved outcomes Reduced chronic pain management

Cost of CPP programmes Cost of supporting MDT

Patient choice of

provider and

location of

intermediate

care

Improves patient satisfaction and access to services

Risk of not providing this increases DNA rates

7 Further information

7.1 Research recommendations

Clinical effectiveness and cost effectiveness of treatments: CPPPs, injections, surgery

Assess impact on return to work

Cost effectiveness of changes in system

Effective methods of education to support implementation

7.2 Other recommendations

Improved patient information

Patient Decision Aid for Low Back Pain

7.3 Evidence base

1. Carvell J. Commissioning Spinal Services – Getting the Service Back on Track: A Guide for Commissioners

of Spinal Services. London: Spinal Task Force, 2013.

2. Falco FJ, Manchikanti L, Datta S, Sehgal N, Geffert S, Onyewu O, Zhu J, Coubarous S, Hameed M, Ward

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SP, Sharma M, Hameed H, Singh V, Boswell MV. An update of the effectiveness of therapeutic lumbar

facet joint interventions. Pain Physician 2012;15-6:E909-53.

3. Carette S, Marcoux S, Truchon R, Grondin C, Gagnon J, Allard Y, Latulippe M. A controlled trial of

corticosteroid injections into facet joints for chronic low back pain. New England Journal of Medicine

1991;325-14:1002-7.

4. Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, Sehgal N, Shah RV, Singh V, Benyamin

RM, Patel VB, Buenaventura RM, Colson JD, Cordner HJ, Epter RS, Jasper JF, Dunbar EE, Atluri SL,

Bowman RC, Deer TR, Swicegood JR, Staats PS, Smith HS, Burton AW, Kloth DS, Giordano J, Manchikanti

L. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal

pain. Pain Physician 2007;10-1:7-111.

5. NICE. Low back pain: (CG88) Early management of persistent non-specific low back pain. London:

National Institute of Clinical Excellence, 2009.

6. Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E,

Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low

back pain with current best practice (STarT Back): a randomised controlled trial. Lancet 2011;378-

9802:1560-71.

7. http://www.keele.ac.uk/sbst/ (accessed 29/09/13/2013).

8. Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR. Group

cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and

cost-effectiveness analysis. Lancet 2010;375-9718:916-23.

9. Lamb SE, Lall R, Hansen Z, Castelnuovo E, Withers EJ, Nichols V, Griffiths F, Potter R, Szczepura A,

Underwood M. A multicentred randomised controlled trial of a primary care-based cognitive behavioural

programme for low back pain. The Back Skills Training (BeST) trial. Health Technology Assessment

2010;14-41:1-253, iii-iv.

10. Wennberg JE, Fisher ES, Goodman DC, Skinner JS. Tracking the Care of Patients with Severe Chronic

Illness: The Dartmouth Atlas of Health Care 2008. Lebanon, New Hampshire: The Dartmouth Institute for

Health Policy and Clinical Practice 2008:1-123.

11. Okie S. A flood of opioids, a rising tide of deaths. New England Journal of Medicine 2010;363-21:1981-5.

12. Martell BA, O'Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, Fiellin DA. Systematic review:

opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Annals of

Internal Medicine 2007;146-2:116-27.

13. Jamison RN, Clark JD. Opioid medication management: clinician beware! Anesthesiology 2010;112-

4:777-8.

7.4 Guide development group for low back pain

A commissioning guide development group was established to review and advise on the content of the

commissioning guide. This group met four times, with additional interaction taking place via email.

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Name Job Title/Role Affiliation

John Carvell Chair Emeritus Consultant Spinal

and Orthopaedic Surgeon

Chair Spinal Taskforce DH and

Chair CRG Complex Spinal

Surgery

Ashley Cole Consultant Orthopaedic and

Spinal Surgeon

Member Spinal Taskforce DH

and CRG Complex Spinal

Surgery Orthopaedic Expert

Working Group

Joe Dias Chair, Musculoskeletal

Commissioning Guidance

Development Project;

Consultant Orthopaedic

Surgeon

British Orthopaedic

Association and

Musculoskeletal CCG

Development Chair

Nigel Henderson Consultant Orthopaedic and

Spinal Surgeon

Member Spinal Taskforce DH

and CRG Complex Spinal

Surgery

Rick Nelson Consultant Neurosurgeon President of Society of British

Neurological Surgeons

Richard Smith Consultant Rheumatologist British Society for

Rheumatology

Awadh Jha General Practitioner and

member of Medway

Commissioning Board

Royal College of General

Practitioners

Paul May Chair of Trauma Programme

of Care Board, NHS England;

Consultant Neurosurgeon

The Walton Centre

Martin Hey Physiotherapist Chair Physiotherapy Pain

Association

Christopher Mercer Physiotherapist Consultant Physiotherapist

Debbie Cook Patient Director National Ankylosing

Spondylitis Society

Judith Fitch Patient BOA Patient Liaison Group

The consultative process has also taken into account the views of the Chartered Society of Physiotherapy, the Faculty of Pain Medicine, the British Pain Society, and specialised Pain Services Clinical Reference Group. Information specialist support provided by Bazian, 10 Fitzroy Square, London, W1T 5HP.

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7.5 Funding statement

The development of this commissioning guidance has been funded by the following sources: DH-RightCare funded the costs of the Guideline Development Group, the literature searches and

provided staff support; The Royal College of Surgeons of England (RCSEng) and the British Orthopaedic Association (BOA)

provided staff to support the guideline development and performed the quality assurance.

7.6 Methods statement

The development of this guidance has followed a defined, NICE Accredited process. This included a

systematic literature review, public consultation and the development of a Guidance Development

Group which included those involved in commissioning, delivering, supporting and receiving surgical

care as well as those who had undergone treatment. An essential component of the process was to

ensure that the guidance was subject to peer review by senior clinicians, commissioners and patient

representatives. Details are available at this site:

www.rcseng.ac.uk/providers-commissioners/docs/rcseng-ssa-commissioning-guidance-process-

manual/at_download/file

7.7 Conflicts of Interest Statement

Individuals involved in the development and formal peer review of commissioning guides are asked to complete a conflict of interest declaration. It is noted that declaring a conflict of interest does not imply that the individual has been influenced by his or her secondary interest, but this is intended to make interests (financial or otherwise) more transparent and to allow others to have knowledge of the interest. Professor Joe Dias (Chair, Musculoskeletal Commissioning Guidance Development Project; Consultant Orthopaedic Surgeon) has seen and approved these. All records are kept on file, and are available on request.

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Appendix 2: Red and Yellow Flags

Red Flags

History and Examination in a patient with back pain which indicates possible serious spinal pathology

History:

- age 16< or >50 with NEW onset back pain - non-mechanical pain (worse at rest, interferes with sleep) - thoracic pain - previous history of malignancy (however long ago) - weight loss (unexplained) - previous long standing steroid use - recent serious illness - recent significant infection - fevers/rigors - urinary retention/incontinence - faecal incontinence - altered perianal sensation (wiping bottom) - limb weakness

Examination: - limb weakness - generalised neurological deficit - hyper-reflexia, clonus, extensor plantar responses - saddle anaesthesia (loss of pinprick sensation unilaterally or bilaterally) - reduced anal tone/squeeze - new/progressive spinal deformity - urinary retention

Yellow Flags

The most important and widely used model for the examination of the spine is the Bio-Psycho-Social model. This aims to encompass all elements of a patient's problem. The aim of the psychosocial assessment is to find those patients who are likely to develop chronicity. The factors which highlight the patient's risk of chronicity can be identified using the 'yellow flags' system:

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- Attitudes - towards the current problem. Does the patient feel that with appropriate help and self-management they will return to normal activities?

- Beliefs - The most common misguided belief is that the patient feels they have something serious causing their problem - usually cancer. 'Faulty' beliefs can lead to catastrophisation.

- Compensation - Is the patient awaiting payment for an accident/injury at work/RTA? - Diagnosis - or more importantly iatrogenesis. Inappropriate communication can lead to

patients misunderstanding what is meant, the most common examples being 'your disc has popped out' or 'your spine is crumbling'.

- Emotions - Patients with other emotional difficulties such as on-going depression and/or anxiety states are at a high risk of developing chronic pain.

- Family - There tends to be two problems with families, either over bearing or under supportive.

- Work - The worse the relationship, the more likely they are to develop chronic LBP. Appendix 3: STarT Back Tool management based on stratification. 1. Low risk. Patients at low risk of poor outcome each receives a 30 minute face to face appointment that consists of a comprehensive assessment including a physical examination, individualised education and reassurance about diagnosis, prognosis and treatments and advice about medication, activity and work. This is supplemented with written materials (the Back Book and a leaflet about local exercise and activity facilities) and a 15-minute educational DVD. 2. Medium risk. For these patients a referral to physiotherapy is beneficial both in terms of their clinical outcomes and cost savings. Physiotherapists negotiate an individualised treatment plan with the patient aiming to reduce symptoms, disability and promote self-management. They use a range of evidence based interventions including advice, explanation, reassurance, education, manual therapy and exercises. Acupuncture treatment is provided at the discretion of the physiotherapist and patient. Consistent with evidence based guidelines bed rest, traction, massage and electrotherapy were not recommended. 3. High risk. For these patients a referral to an appropriately skilled physiotherapist is beneficial both in terms of their clinical outcomes and cost savings. In the STarT Back trial it was cost-effective to allow longer appointments for high-risk patients. The high risk treatment (outlined below) is in addition to the treatments provided for medium risk patients. a. Build rapport, validate and normalise the patient’s experiences. b. Conduct a comprehensive biopsychosocial assessment (physical examination, exploration of the impact that pain is having on the patient’s physical and psychosocial functioning, identification of the patient’s beliefs and expectations regarding LBP and its

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management and structured identification of potential obstacles to recovery). c. Address gaps in patients’ knowledge, correct possible misunderstandings and provide a credible explanation for their pain (e.g. cause, mechanisms, prognosis, role of investigations and treatments). d. Create opportunities for patients to respond differently to difficult internal experiences (thoughts, feelings and bodily sensations) and to maintain or alter activity in keeping with their goals. e. Provide guidance on a variety of pain rehabilitation techniques including pacing and graded activity. f. Provide support in returning to usual activities, sleep and work. g. Specifically focus on the psychological prognostic indicators (catastrophysing, low mood, anxiety and pain related fear) with the adoption of simple cognitive behavioural techniques. h. Encourage patients to put skills into practice between sessions, review and reinforce progress and problem solve difficulties. Emphasise the role of active self-management of on-going or future episodes. Appendix 4: Quality Observatory dashboard for commissioners

To support the commissioning guides the Quality Dashboards show information derived from Hospital Episode Statistics (HES) data. These dashboards show indicators for activity commissioned by CCGs across the relevant surgical pathways and provide an indication of the quality of care provided to patients.

The dashboards are supported by a metadata document to show how each indicator was derived.

http://rcs.methods.co.uk/dashboards.html

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Example CCG

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Appendix 5: Excluded diagnostic codes

Radicular pain G551 Nerve root and plexus compressions in intervertebral disc disorder G552 Nerve root and plexus compressions in spondylosis M472 Other spondylosis with radiculopathy M480 Spinal Stenosis M501 Cervical disc disorder with radiculopathy M502 Other cervical disc displacement M510 Lumbar and other intravertebral disc disorders with mylopathy M511 Lumbar and other intervertbral disc disorders with radiculopathy M512 Other specified intervertebral disc displacement M541 Radiculopathy M543 Sciatica M544 Lumbago with sciatica

Cauda Equina Syndrome G834

Primary malignant tumours of osseoligamentous origin

C412 Malignant neoplasm of vertebral column D166 Benign neoplasm of vertebral column D480 Neoplasm uncert or unknown behaviour of bone & artic cart

Primary malignant tumours of neurological origin

C701 Malignant neoplasm of spinal meninges C720 Malignant neoplasm of spinal cord C721 Malignant neoplasm of cauda equina D320 Benign neoplasm of cerebral meninges D321 Benign neoplasm of spinal meninges D329 Benign neoplasm of meninges, unspecified D334 Benign neoplasm of spinal cord D361 Benign neoplasm of periph nerves & autonomic nervous system D421 Neoplasm uncert/unkn behav spinal meninges D434 Neoplasm uncert/unkn behav spinal cord D437 Neoplasm uncert/unkn behav oth part of central nervous sys D439 Neoplasm uncert/unkn behav central nervous system, unsp

Secondary malignant tumours M495 Metastatic fracture of vertebra C77x,C78x, C79x, C80x Secondary malignant neoplasm

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Spinal infection M462 Osteomyelitis of vertebra M463 Infection of intervertebral disc (pyogenic) M464 Discitis, unspecified M465 Other infective spondylopathies M490 Tuberculosis of spine M491 Brucella spondylitis M492 Enterobacterial spondylitis, and M493 Spondylopathy in other infectious and parasitic diseases NEC

Spinal cord injury S140 Concussion and oedema of cervical spinal cord S141 Other and unspecified injuries of cervical spinal cord S240 Concussion and oedema of thoracic spinal cord S241 Other and unspecified injuries of thoracic spinal cord S340 Concussion and oedema of lumbar spinal cord S341 Other injury of lumbar spinal cord S343 Injury of cauda equina, T093 Injury of spinal cord, level unspecified

Vertebral column injury with no evidence of osteoporosis

S120 Fracture of first cervical vertebra S121 Fracture of second cervical vertebra S122 Fracture of other specified cervical vertebra S127 Multiple fractures of cervical spine S128 Fracture of other parts of neck S129 Fracture of neck, part unspecified S130 Traumatic rupture of cervical intervertebral disc S131 Dislocation of cervical vertebra S132 Dislocation of other and unspecified parts of neck S133 Multiple dislocations of neck S220 Fracture of thoracic vertebra S221 Multiple fractures of thoracic spine S230 Traumatic rupture of thoracic intervertebral disc S231 Dislocation of thoracic vertebra S232 Dislocation of other and unspecified parts of thorax S320 Fracture of lumbar vertebra S321 Fracture of sacrum S322 Fracture of coccyx S330 Traumatic rupture of lumbar intervertebral disc S331 Dislocation of lumbar vertebra S332 Dislocation of sacroiliac and sacrococcygeal joint S344 Injury of lumbosacral plexus T021 Fractures involving thorax with low back and pelvis AND absence of codes indicating osteoporosis

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(as set out below).

Vertebral column injury with evidence of osteoporosis

Codes for Vertebral column injury (as set out above) together with diagnosis codes M80.0-M80.9 M810-M819 M484 Fatigue fracture of vertebra M485 Collapsed vertebra not elsewhere classified

Appendix 6: Spinal Complications

DURAL TEAR

ICD-10 C960, T812

ICD-9

NERVE INJURY

ICD-10 S342, S344, T094

ICD-9

CAUDA EQUINA SYNDROME

ICD-10 G834, S341, S343

ICD-9

SPINAL CORD INJURY

ICD-10 T845, T093, S241

ICD-9

VASCULAR INJURY

ICD-10 T817

ICD-9

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INFECTION CAUSED BY THE PROSTHESIS

ICD-10 T845

ICD-9 9966

INFECTION RECORDED ELSEWHERE IN THE BODY

ICD-10 T814 G061

ICD-9 9985

DVT

ICD-10 I801, I802

ICD-9 4511

PE

ICD-10 I260, I269

ICD-9 4150, 4151

AMI

OPCS K40-, K41-, K42-, K43-, K44-, K45-, K46-, K49-, K50-, K63-

ICD-10 I200, I21-, I22-, I248, I460

GI BLEED

ICD-10 K920, K921, K922

STROKE

ICD-10 I60-, I61-, I62-, I63-, I64-, I65-, I66-, I670, I671, I672, I677, I678, I679, G451, G452,

G453, G454, G458, G459

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RENAL FAILURE

ICD-10 N17-, N19-

Appendix 7: British Spine Registry (www.bsrcentre.org.uk)

The British Spine Registry (BSR) was developed by the British Association of Spine Surgeons and

Amplitude and launched in May 2012 after 2 years of development involving input from patient

groups and surgeons. It is a secure, web-based registry with patients consenting to have their

data stored. The BSR is available and free-of-charge to all Spinal Consultants who are members

of the British Association of Spine Surgeons or the British Scoliosis Society. The BSR stores

patient demographics and Consultants can input details of diagnosis, surgical procedures,

complications and Patient Reported Outcome Measures (PROMs). The system can email the

patients to complete their PROMs at defined times after surgery. PROMs can also be collected

in clinics using kiosks or touchscreen tablets. This is an ideal system to allow spinal surgeons to

collect outcome data on the procedures they perform. It could also be easily modified for data

collection in MSK screening services and providers of CPPP.

Spine Tango is a similar system owned by the Spine Society of Europe with paper based data

collection. It is currently used by four large spinal centres in the UK.

ICHOM (http://ichom.org/) is an international organisation aimed at optimising and

harmonising outcome measures: “Our aim is to transform health care by making transparent

the results that really matter to patients. We're working with patients, leading providers, and

registries to create a global standard for measuring results by medical condition, from prostate

cancer to coronary artery disease.”