Greater Manchester EUR Policy Statement on: Radiofrequency Denervation for Back Pain GM Ref: GM004 Version: 2.1 (6 June 2018)

Transcription

1 Greater Manchester EUR Policy Statement on: Radiofrequency Denervation for Back Pain GM Ref: GM004 Version: 2.1 (6 June 2018)

2 Commissioning Statement Radiofrequency Denervation for Back Pain Policy Exclusions (Alternative commissioning arrangements apply) Policy Inclusion Criteria Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect). Radiofrequency denervation is commissioned if the provider is using thermocoagulation radiofrequency denervation and this is undertaken by experienced clinicians using the correct technique within an environment suitable for delivery of this procedure, and all appropriate back up is available. Pulsed radiofrequency denervation will not be commissioned from new providers (i.e. new contracts post-dating the adoption of this policy). Existing providers may continue to use pulsed radiofrequency denervation, at the clinician s discretion, provided they can prove their outcomes are equivalent to those providers using thermo-coagulation radiofrequency denervation. When equipment is replaced or updated we would expect the provider to move to thermo-coagulation radiofrequency denervation. NOTE: Patients who have had prior approval for double diagnostic or medial branch blocks are considered to already have prior approval for radiofrequency denervation if the response to both injections is positive. Prior to consideration for radiofrequency denervation the patient should: have previously engaged with and complied with the advice / treatments advised by specialist pain management services have a history of chronic, function-limiting pain of at least 12 months duration have undergone a diagnostic medial branch block which provided between % improvement in pain have used the period of pain relief (from the diagnostic FJI) to undergo rehabilitation in close co-operation with other specialities unless clinically contraindicated Radiofrequency denervation is commissioned for individuals who meet the following criteria: non-surgical treatment has not worked for them i.e. the patient has demonstrated failure to respond to, or had a loss of response, to other treatment options AND the main source of pain is thought to come from structures supplied by the medial branch nerve AND they have moderate or severe levels of localised back pain (rated as 5 or more on a visual analogue scale, or equivalent) at the time of referral. AND it is only being performed in patients with chronic low back pain after a positive response to a diagnostic medial branch block OR other treatment options are contraindicated and this is clearly documented GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 2 of 23

3 NOTE: Do not offer imaging for people with low back pain with specific facet join pain as a prerequisite for radiofrequency denervation. Patients should not have radiofrequency denervation if: they are pregnant or breast feeding there are any comorbidities present that contraindicate radiofrequency denervation they are unable to be positioned in the correct way prior to treatment Following radiofrequency denervation and where clinically appropriate: The patient should be referred for and participate in active rehabilitation. In addition, wherever possible, patients should be encouraged to: participate in mobilisation or rehabilitation therapy take effective pain relief medication where indicated (and where it is available) be referred for weight management support Funding Mechanism Individual prior approval provided the patient meets the above criteria. Requests must be submitted with all relevant supporting evidence. NOTE: Where individual prior approval has already been given for diagnostic facet joint injection(s), in those cases individuals are already considered to have prior approval for radiofrequency denervation provided the injection(s) gave a positive response. If the patient does not meet the criteria: an individual funding request can be made if there is a good case for clinical exceptionality. Requests must be submitted with all relevant supporting evidence. Repeat Radiofrequency Denervation Patients requiring a second or subsequent repeat treatment with radiofrequency denervation will need prior approval for funding of this treatment. Requests should include details of the following: A clear statement as to why previous radiofrequency denervation failed and steps to be taken to avoid subsequent failure of radiofrequency denervation OR A statement as to why the repeat treatment is necessary if the initial treatment was considered effective - to include the degree of pain relief gained and length of time the initial radiofrequency denervation was effective for. Repeat radiofrequency denervation should not be considered if the initial benefit was for less than 16 months (NICE NG59 Cost-Effectiveness and National Back Pain and Radicular Pain Pathway). Funding Mechanism Individual prior approval provided the patient meets the above criteria. Requests must be submitted with all relevant supporting evidence. If the patient does not meet the criteria: an individual funding request can be made if GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 3 of 23

4 there is a good case for clinical exceptionality. Requests must be submitted with all relevant supporting evidence. Clinical Exceptionality Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. Exceptionality means a person to which the general rule is not applicable. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: Significantly different to the general population of patients with the condition in question. and as a result of that difference They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 4 of 23

5 Contents Commissioning Statement... 2 Policy Statement... 6 Equality & Equity Statement... 6 Governance Arrangements... 6 Aims and Objectives... 6 Rationale behind the policy statement... 7 Treatment / Procedure... 7 Epidemiology and Need... 7 Adherence to NICE Guidance... 8 Audit Requirements... 8 Date of Review... 8 Glossary... 8 References... 8 Governance Approvals... 9 Appendix 1 Evidence Review Appendix 2 Post Consultation Additional Evidence Review Summary Table Appendix 2 Diagnostic and Procedure Codes Appendix 3 Version History GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 5 of 23

6 Policy Statement Greater Manchester Shared Services (GMSS) Effective Use of Resources (EUR) Policy Team in conjunction with GM EUR Steering Group have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy GMSS has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). Equality & Equity Statement GMSS/CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act GMSS/CCG is committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, GMSS/CCG will have due regard to the different needs of protected characteristic groups, in line with the Equality Act This document is compliant with the NHS Constitution and the Human Rights Act This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GMSS Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their starting point is considered to be further back than any other group. This will be reflected in GMSS evidencing taking due regard for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact policyfeedback.gmscu@nhs.net. Governance Arrangements Greater Manchester EUR policy statements will be ratified by the Greater Manchester Association Governing Group (AGG) prior to formal ratification through CCG Governing Bodies. Further details of the governance arrangements can be found in the Greater Manchester EUR Operational Policy. Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by: reducing the variation in access to treatments/procedures. GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 6 of 23

7 ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. promoting the cost-effective use of healthcare resources. Rationale behind the policy statement NICE guidance and other systematic reviews have highlighted the lack of evidence of effectiveness for this procedure for back pain. In light of this evidence radiofrequency facet joint denervation is considered to be an unproven therapy and therefore is not routinely commissioned. Treatment / Procedure Radiofrequency Denervation is a system using heat generated by radio waves targeted at specific nerves to temporarily interfere with their ability to transmit pain signals. The effectiveness of the treatment is not clear from the evidence available and further high quality studies are needed to determine its effectiveness. This policy complies with the advice in NICE CG88 and as a result Radiofrequency Denervation for back pain is not routinely commissioned. Use of this therapy should be within a recognised trial. Back pain is a common problem that affects most people at some point in their life. It may be triggered by bad posture while sitting or standing, bending awkwardly, or lifting incorrectly. It is not generally caused by a serious condition. In most cases, back pain will improve in a few weeks or months, although some people experience long-term pain or pain that keeps coming back. Epidemiology and Need Low Back pain 2 Back pain is extremely common % of people in the UK report back pain at some time in their lives. Low back pain has an estimated lifetime prevalence of 84% worldwide. The worldwide prevalence of chronic low back pain is about 23%.Simple back pain tends to affect those between 30 and 60 years of age, starting between 30 and 50. First onset outside this range should arouse suspicion of a sinister cause. Back pain is second only to the common cold as a cause of lost days at work. In 2005 the Trades Union Congress (TUC) estimated that 4.9 million working days per year are lost due to back pain. Research by the British Chiropractic Association found that 48% of people in Britain suffer from back or neck pain at any one time, possibly associated with spending an increasing amount of time seated at office desks. Highly demanding jobs, prolonged standing and awkward lifting are the most consistent factors predisposing to low back pain. A systematic review did not identify occupational carrying as an independent risk factor. Psychosocial work-related stress is an associated factor. Genetics may play a part. Smoking and obesity increase risk. Thoracic back pain 2 Prevalence data ranged from % (at any one time), % (7-day), % (1-month), % (3-month), % (1-year) and % (lifetime). Studies reported a higher prevalence for thoracic back pain in children and adolescents, especially for females. In children and adolescents, thoracic back pain was associated with female gender, postural changes associated with backpack use, backpack weight, other musculoskeletal symptoms, participation in specific sports, chair height at school and difficulty with homework. Poorer mental health and age transition from early to late adolescence were also significant risk factors. In adults, thoracic back pain was associated with concurrent other musculoskeletal symptoms and difficulty in performing activities of daily living. GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 7 of 23

8 Adherence to NICE Guidance This policy adheres fully to the recommendations made in NICE CG88 (Low back pain: Early management of persistent non-specific low back pain) Section 'Do not refer people for radio frequency facet joint denervation'. Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. Date of Review Three years from the date of the last review, unless new evidence is available sooner. The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review. Glossary Term Chiropractic Musculoskeletal Nerves NICE NICE CG Pain signals Postural Psychosocial Radio waves Systematic Review Thoracic Meaning A system of complementary medicine based on the diagnosis and manipulative treatment of misalignments of the joints, especially those of the spinal column Relating to or denoting the musculature and skeleton together A whitish fibre or bundle of fibres in the body that transmits impulses of sensation to the brain or spinal cord, and impulses from these to the muscles and organs National Institute for Health and Care Excellence NICE Clinical Guidance Impulses varied in the nerve fibres that alert the brain to pain stimuli Pertaining to the posture or position of the body, the attitude or carriage of the body as a whole, or the position of the limbs (the arms and legs) Relating to the interrelation of social factors and individual thought and behaviour Electromagnetic waves of a frequency between about 10 4 and or Hz, as used for long-distance communication A systematic review answers a defined research question by collecting and summarising all the available evidence that fits the pre-specified eligibility criteria of the review Relating to the thorax (the part of the body of a mammal between the neck and the abdomen) References 1. Greater Manchester Effective Use of Resources Operational Policy 2. Patient + articles on Patient.co.uk on the epidemiology of back and neck pain GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 8 of 23

9 3. National Back Pain and Radicular Pain Pathway 4. NICE NG59: Low back Low back pain and sciatica in over 16s: assessment and management Governance Approvals Name Date Approved Greater Manchester Effective Use of Resources Steering Group 18/11/2015 Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning 12/07/2016 Greater Manchester Association Governing Group 19/07/2016 Bury Clinical Commissioning Group 07/09/2016 Bolton Clinical Commissioning Group 23/09/2016 Heywood, Middleton & Rochdale Clinical Commissioning Group 19/07/2016 Central Manchester Clinical Commissioning Group 01/11/2016 North Manchester Clinical Commissioning Group 26/08/2016 Oldham Clinical Commissioning Group 19/07/2016 Salford Clinical Commissioning Group 19/07/2016 South Manchester Clinical Commissioning Group 01/11/2016 Stockport Clinical Commissioning Group 19/07/2016 Tameside & Glossop Clinical Commissioning Group 03/08/2016 Trafford Clinical Commissioning Group 20/09/2016 Wigan Borough Clinical Commissioning Group 07/09/2016 GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 9 of 23

10 Appendix 1 Evidence Review Radiofrequency Denervation for Back Pain GM004 Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below: Database NICE Cochrane York BMJ Clinical Evidence BMJ Best Practice Result NICE NG59: Low back pain and sciatica in over 16s: assessment and management (Added at review: July 2017) - This guidance replaces CG88: Low back pain: Early management of persistent non-specific low back pain (also cited below) Radiofrequency denervation for neck and back pain (Review), Niemisto L, Kalso EA, Malmivaara A, Seitsalo S, Hurri H, Cochrane database of systematic review Radiofrequency denervation for facet joint low back pain: a systematic review, Poetscher AW, Gentil AF, Lenza M, Ferretti M., Spine 2014; 39(14): e842-e849. BMJ Clinical Evidence review: Low back pain (chronic): Radiofrequency denervation, Roger Chou, Search date: April 2009 BMJ Best Practice - Summary statement: Radiofrequency denervation (website extract cited below) Other Best Bets Website Review: Radiofrequency denervation for lumbar zygapophysial joint pain, Report By: Simon Carley - Consultant in Emergency Medicine, Institution: Manchester Royal Infirmary, Date Submitted: 6th July 2005 Effect of Radiofrequency Denervation on Pain Intensity on Pain Intensity Among Patients With Chronic Low Back Pain, The Mint Randomized Clinical Trials, Johan N. S. Juch, MD et al, JAMA July 4, 2017 Volume 318, Number 1 (Added at review: July 2017) Summary of the evidence When the policy was initially drafted all of the evidence reviews felt that the level of evidence and consistency in findings was insufficient to show that radiofrequency denervation for back pain was an effective treatment. NICE CG88 (Low back pain: Early management of persistent non-specific low back pain) recommended that this therapy is not routinely offered for back pain. At the time of the July 2017 review new NICE guidance on low back pain had been published in November 2016, NG59: Low back pain and sciatica in over 16s: assessment and management, which replaced CG88: Low back pain in adults: early management. The NICE guidance had slightly different criteria for patient selection to the GM policy but essentially supported our commissioning approach. The Mint Randomized Clinical Trials looked at radiofrequency denervation as a primary intervention added to standardized exercise program and psychological support. Locally, radiofrequency denervation is not commissioned at this stage of the back pain pathway and is only offered when all other treatment options have failed or are contra-indicated. GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 10 of 23

11 The evidence Levels of evidence Level 1 Level 2 Level 3 Level 4 Level 5 Meta-analyses, systematic reviews of randomised controlled trials Randomised controlled trials Case-control or cohort studies Non-analytic studies e.g. case reports, case series Expert opinion 1. LEVEL 1: NICE GUIDANCE CG88 Low back pain: Early management of persistent non-specific low back pain, May 2009 (This guidance has now been replaced by NICE NG59 - cited below) GUIDANCE Do not refer people for any of the following procedures: intradiscal electrothermal therapy (IDET) percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) radiofrequency facet joint denervation. RESEARCH RECOMMENDATIONS 4.5 Invasive procedures What is the effectiveness and cost-effectiveness of facet joint injections and radiofrequency lesioning for people with persistent non-specific low back pain? Why this is important Many invasive procedures are performed on people with persistent non-specific low back pain. These are usually undertaken after the condition has lasted a long time (more than 12 months). Procedures such as facet joint injections and radiofrequency lesioning are performed regularly in specialist pain clinics. There is evidence that pain arising from the facet joints can be a cause of low back pain, but the role of specific therapeutic interventions remains unclear. Case studies provide some evidence for the effectiveness of facet joint injections and medial branch blocks, but randomised controlled trials give conflicting evidence. Robust trials, including health economic evaluations, should be carried out to determine the effectiveness and cost effectiveness of invasive procedures in particular, facet joint injections and radiofrequency lesioning. These should include the development of specific criteria for patient selection and a comparison with non-invasive therapies 2. LEVEL N/A: NICE GUIDANCE NICE NG59: Low back pain and sciatica in over 16s: assessment and management (This guidance replaces NICE CG88: Low back pain) 1.3 Invasive treatments for low back pain and sciatica Non-surgical interventions Spinal injections Do not offer spinal injections for managing low back pain. Radiofrequency denervation Consider referral for assessment for radiofrequency denervation for people with chronic low back pain when: GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 11 of 23

12 non-surgical treatment has not worked for them and the main source of pain is thought to come from structures supplied by the medial branch nerve and they have moderate or severe levels of localised back pain (rated as 5 or more on a visual analogue scale, or equivalent) at the time of referral Only perform radiofrequency denervation in people with chronic low back pain after a positive response to a diagnostic medial branch block Do not offer imaging for people with low back pain with specific facet joint pain as a prerequisite for radiofrequency denervation. Epidurals Consider epidural injections of local anaesthetic and steroid in people with acute and severe sciatica Do not use epidural injections for neurogenic claudication in people who have central spinal canal stenosis. 3. LEVEL 1: SYSTEMATIC REVIEW BMJ Clinical Evidence review: Low back pain (chronic): Radiofrequency denervation, Roger Chou, Search date: April 2009 SUMMARY STATEMENT Symptom improvement Compared with sham treatment or placebo: We don't know whether radiofrequency denervation is more effective than placebo at reducing pain in people with presumed facet joint or discogenic low back pain (very low-quality evidence). Functional improvement Compared with sham treatment or placebo We don't know whether radiofrequency denervation is more effective at improving function in people with presumed facet joint or discogenic low back pain (very lowquality evidence). BENEFITS Radiofrequency denervation versus no treatment/sham treatment or usual care: We found one systematic review (search date 2008; 8 RCTs), which evaluated radiofrequency denervation for non-radicular low back pain. Six RCTs included in the review (322 people) evaluated radiofrequency denervation for presumed facet joint pain versus sham treatment, and one RCT (49 people) included in the review evaluated radiofrequency denervation for presumed discogenic back pain versus lidocaine injection. Four RCTs of radiofrequency denervation for presumed facet joint pain were rated higher quality by the review. The first higher-quality RCT included in the review (40 people selected by controlled facet joint blocks and an ablation technique believed to be optimal) found that radiofrequency denervation improved generalised, back, and leg pain compared with sham treatment at 6 months (0 10 visual analogue scale [VAS]: 1.4 points to 1.6 points), but the difference was not statistically significant for back pain (the main symptom thought to be associated with facet pain). The review reported that baseline scores in the radiofrequency denervation group were on average 1.6 points higher, which suggests inadequate randomisation. The review reported that the other three higher-quality RCTs used uncontrolled diagnostic facet joint blocks to select the people included in the trials, and, may have used suboptimal ablation techniques, and all reported conflicting results. The second higher-quality RCT (30 people) found that radiofrequency denervation moderately improved mean VAS pain and Oswestry Disability Index (ODI) scores through 2 months (pain: mean VAS score on a 0 10 VAS: 2.4 with radiofrequency v 0.4 with placebo; P <0.05; ODI: 11.1 with radiofrequency denervation v +1.7 with placebo; P <0.05 The third higher-quality RCT (70 people) found radiofrequency denervation superior to sham treatment for mean improvement in Roland Morris Disability Questionnaire (RMDQ) scores at 4 weeks (RMDQ GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 12 of 23

13 scores: 8.4 with radiofrequency denervation v 2.2 with placebo; P = 0.05), but there were no statistically significant differences in ODI or VAS pain scores between groups (reported as not significant; P value not reported). However, the RCT found no significant difference between groups for RMDQ score at 12 weeks. The fourth higher-quality RCT (82 people) found no differences between radiofrequency denervation compared with sham treatment on any outcome (further data not reported). The first lower-quality RCT included in the review (60 people) found that conventional but not pulsed radiofrequency denervation improved pain (VAS 0 10 scale: points, significance not reported) and function (4 6 points on the ODI; significance not reported) compared with sham treatment at 1 year. The review reported that the second lower-quality RCT had serious methodological shortcomings, including lack of intention-to-treat analysis, and therefore was not reported. The one RCT included in the review (49 people) that evaluated radiofrequency for presumed discogenic pain (based on positive lumbar provocative discography) found that radiofrequency denervation of the ramus communicans nerves significantly improved pain, SF-36 bodily pain, and SF-36 physical function scores compared with lidocaine injection after 4 months (pain: mean VAS [0 10 scale] pain scores: 3.8 with radiofrequency denervation v 6.3 with lidocaine injection; P <0.05; SF-36 bodily pain: 44 with radiofrequency denervation v 32 with lidocaine injection; P <0.05; SF- 36 physical function: 59 with radiofrequency denervation v 46 with lidocaine injection; P <0.05). The review reported that the RCT was of lower quality. HARMS Radiofrequency denervation versus no treatment/sham treatment or usual care: The review reported that one of the included RCTs found a case of mild, subjective, and transient lower limb weakness after radiofrequency denervation. The review included two other RCTs that found no difference in adverse effects between radiofrequency denervation compared with sham treatment, although radiofrequency denervation was associated with trends towards increased post-procedural pain. COMMENT: The RCTs in the review included people with pain presumably arising from the facet joint or intervertebral disc. However, the accuracy of methods for identifying patients with facet joint or discogenic pain is unknown. RCTs of radiofrequency denervation for presumed facet joint pain are difficult to interpret because higher-quality studies reported conflicting studies, some RCTs may have used suboptimal techniques, and the only RCT to use controlled facet joint diagnostic blocks to select patients for inclusions reported baseline differences between the treatment and sham groups. 4. LEVEL 1: SYSTEMATIC REVIEW Radiofrequency denervation for neck and back pain (Review), Niemisto L, Kalso EA, Malmivaara A, Seitsalo S, Hurri H, Cochrane database of systematic review ABSTRACT Background: The diagnosis of cervical or lumbar zygapophyseal joint pain can only be made by using local anaesthesia to block the nerves supplying the painful joint. There is a lack of effective treatment for chronic zygapophyseal joint pain or discogenic pain. Radiofrequency denervation appears to be an emerging technology, with substantial variation in its use between countries. Objectives: To assess the effectiveness of radiofrequency denervation for the treatment of musculoskeletal pain disorders. Search methods: We searched MEDLINE, PsycLIT, and EMBASE from start to February 2002, plus the Cochrane Library 2002, Issue 2. The references of identified articles were checked and three experts in the field of radiofrequency treatment were consulted to identify studies we might have missed. Selection criteria: Randomized controlled trials (RCTs) of radiofrequency denervation for musculoskeletal pain disorders, with no language or date restrictions. Data collection and analysis: Two authors selected RCTs that met predefined inclusion criteria, extracted the data, and assessed the main results and methodological quality of the selected trials, using standardized forms. Qualitative analysis was conducted to evaluate the level of scientific evidence. Main results: We found only nine articles, reporting on seven relevant RCTs. Six of the seven were considered to be high-quality. The selected trials included 275 randomized patients, 141 of whom GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 13 of 23

14 received active treatment. One study examined cervical zygapophyseal joint pain, two cervicobrachial pain, three lumbar zygapophyseal joint pain, and one discogenic low-back pain. The study sample sizes were small, follow-up times short, and there were some deficiencies in patient selection, outcome assessments, and statistical analyses. The level of scientific evidence for the short-term effectiveness of radiofrequency denervation was limited for cervical zygapophyseal joint and cervicobrachial pain, and conflicting for lumbar zygapophyseal joint pain. There was limited evidence suggesting that intradiscal radiofrequency thermocoagulation was not effective for discogenic low-back pain. Authors' conclusions: The selected trials provide limited evidence that radiofrequency denervation offers short-term relief for chronic neck pain of zygapophyseal joint origin and for chronic cervicobrachial pain; conflicting evidence on the short-term effect of radiofrequency lesioning on pain and disability in chronic low-back pain of zygapophyseal joint origin; and limited evidence that intradiscal radiofrequency thermocoagulation is not effective for chronic discogenic low-back pain. There is a need for further highquality RCTs with larger patient samples and data on long-term effects, for which current evidence is inconclusive. Furthermore, RCTs are needed in non-spinal indications where radiofrequency denervation is currently used without any scientific evidence. 5. LEVEL 1: SYSTEMATIC REVIEW Radiofrequency denervation for facet joint low back pain: a systematic review, Poetscher AW, Gentil AF, Lenza M, Ferretti M., Spine 2014; 39(14): e842-e849. ABSTRACT Study Design: A systematic review and meta-analysis of randomized controlled trials. Objective: To assess treatment effects (benefits and harms) of radiofrequency denervation for patients with facet joint-related chronic low back pain. Summary of Background Data: There is no consensus regarding the treatment efficacy of facet joint radiofrequency denervation (FJRD) and how it compares with nerve blockades and joint infiltration with anesthetics and/or corticosteroids. Methods: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and LILACS for randomized controlled trials that compared FJRD with blockades, infiltrations, or placebo. Primary outcomes were pain, functional status, and quality of life. Secondary outcomes were costeffectiveness and complications. Results: Fifteen studies were selected and 9 were eligible. Overall quality of evidence was rated low to moderate. The evidence favored FJRD regarding pain control. There was no sufficient evidence for costeffectiveness and complications. Conclusion: The available evidence reviewed in this study should be interpreted with caution. The data indicate that FJRD is more effective than placebo in pain control and functional improvement and is also possibly more effective than steroid injections in pain control. Complications and adverse effects were not sufficiently reported to allow comparisons, and there was no evidence for cost-effectiveness. Highquality randomized controlled trials addressing pain, function, quality of life, complications, and costeffectiveness are urgently needed. 6. LEVEL 1: SYSTEMATIC REVIEW Best Bets Website Review: Radiofrequency denervation for lumbar zygapophysial joint pain, Report By: Simon Carley - Consultant in Emergency Medicine, Institution: Manchester Royal Infirmary, Date Submitted: 6th July 2005 Three Part Question: [In patients with chronic low back pain of zygapophysial joint origin] is [radiofrequency denervation of medial lumbar nerves better than standard rehabilitation] at [improving pain and function] Clinical Scenario: A 55 year old woman represents to her general practitioner with back pain of 3 years duration. Previous assessments and investigations have not suggested a serious cause of her back pain but it so severe that she has had to give up work and has become depressed. She attends as she has read on the internet that the nerves to the joints in the back can be electrified and that this will cure her pain. She asks you if this is true and if so could you refer her for the treatment. GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 14 of 23

15 Search Strategy: Medline June OVID via ATHENS.[low back pain.mp. or exp Low Back Pain/ or back pain.mp. or exp Back Pain/ or lumbar pain.mp.] and [zygapophysial.mp. or exp Zygapophyseal Joint/ or facet joint.mp.] and [radio$.mp. or radiofrequency.mp. or exp DENERVATION/ or denervation.mp.] limit to humans and english language and abstracts. Search Outcome: Medline.86 papers found of which one 2 recent high quality systematic reviews were found. In addition a recent clinical trial was identified. Relevant Paper(s) Author, date and country Niemisto l 2003 Finland Slipman CW 2003 USA Mikeladz e G 2003 USA Patient group Randomised controlled trials of radiofrequency denervation for neck and back pain. Identified through wide ranging search under the auspices of the Cochrane Collaboration. Clinical trials of zygapophysial joint injections for patients with chronic back pain 114 patients in a pain management clinic. Retrospective Study type (level of evidence) Systematic review. Systematic review (without metaanalysis) Observation al retrospective cohort Outcomes Key results Number of papers found Inclusion criteria in trials. Principle results Number of papers found Patient characteris tics Principle outcome measures Pain relief as measured on VAS. 7 RCTs were identified. 6 were high quality. 3 papers (including a total of 142 patients) specifically looked at lumbar zygapophysial pain. All were in chronic back pain. All patients in the lumbar trials had confirmatory diagnostic blocks before being considered for denervation. One study showed a small decrease in short term pain (van Kleef), one showed a neutral effect and one was flawed due to a lack of intention to treat. There was conflicting evidence with regard to function scores. No formal meta-analysis was performed. 15 studies were found, 4 were prospective trials included in this review. 2 were RCTs, one was a double blind controlled study and one was a case series. Trials included patients unresponsive to other therapies which means that there is a degree of inclusion bias. All patients had chronic back pain. All patients had a confirmatory diagnostic block prior to randomisation. Pain: Conflicting results were found though there does appear to be a benefit in terms of short to medium term pain relief. Disability scores and improvements were less convinving and of questionable clinical significance 46/114 patients did not respond favourably (defined as less than 50% pain reduction). 68 patients had Study Weaknesses Lack of consistent outcome measure in the included trials. Lack of placebo controlled diagnostic blocks may have led to an increased number of false positive included patients. Confirmatory blocks were usually single attempts and may have led to an increase in the number of false positive included patients. This is a low quality design and would have been excluded from the other review GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 15 of 23

16 recruitment. All patients had had a positive response to a diagnostic medial nerve block.83/114 had low back pain. more than 50% pain relief. articles on the grounds of methodological weakness. No control group. Retrospective. Small numbers. Not possible to discriminate between lumbar and cervical patients as analysed together. Comment(s): Low back pain is one of the most common reasons for working age patients to suffer chronic pain, sickness and work loss. Studies have suggested that a significant proportion of patients with low back pain will have pain originating from the zygapophysial joints. A theoretically attractive theraputic intervention is to ablate the medial lumbar nerves that supply the joint, thereby rendering it anaesthetic. In all these studies the presence of zygapophysial pain was confirmed using diagnostic blocks which is an essential precurser to any trial in this area. The two reviews, whilst assessing the same papers come to similar conclusions that there is evidence for a degree of pain relief in the short to medium term but that there is little evidence to suggest that this is match ed by an increase in function. The most recent trial contains no control group and is retrospective and therefore of little help in answering the question. Clinical Bottom Line: In patients with confirmed zygapophysial joint pain radiofrequency ablation of medial lumbar nerves may provide short to medium term pain relief but is unlikely to result in a significantly increased functional capacity. References 1. Niemesto L. Kalso E, Malmivaara A, Seitsalo S, Hurri H. Radiofrequency denervation for neck and back pain: A systematic review within the framework of the cochrane collaboration back review group. Spine 2003;28: Slipman CW, Bhat AL, Gilchrist RV, Issac Z, Chou L, Lenrow DA. A critical review of the evidence for the use of zygapophysial injections and radiofrequency denervation in the treatment of low back pain. The Spine Journal 2003;3: Mikeladze G, Espinal R, Finnegan R, Routon J, Martin D. Pulsed radiofrequency application in treatment of chronic zygapophyseal joint pain. The Spine Journal 2003;3: LEVEL 4: META-ANALYSIS Effect of Radiofrequency Denervation on Pain Intensity on Pain Intensity Among Patients With Chronic Low Back Pain, The Mint Randomized Clinical Trials, Johan N. S. Juch, MD et al, JAMA July 4, 2017 Volume 318, Number 1 NOTE: Some issues with selection bias and unplanned crossover in all 3 studies reviewed. Importance: Radiofrequency denervation is a commonly used treatment for chronic low back pain, but high-quality evidence for its effectiveness is lacking. Objective: To evaluate the effectiveness of radiofrequency denervation added to a standardized exercise program for patients with chronic low back pain. Design, Setting, and Participants: Three pragmatic multicenter, nonblinded randomized clinical trials on the effectiveness of minimal interventional treatments for participants with chronic low back pain (Mint study) were conducted in 16 multidisciplinary pain clinics in thenetherlands. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain, a positive diagnostic block at the facet joints (facet joint trial, 251 participants), sacroiliac joints (sacroiliac joint trial, 228 participants), or a combination of facet joints, sacroiliac joints, or intervertebral disks (combination trial, 202 participants) and were unresponsive to conservative care. Interventions: All participants received a 3-month standardized exercise program and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well. This is usually a 1-time procedure, but the maximum number of treatments in the trial was 3. GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 16 of 23

17 Main Outcomes and Measures: The primary outcome was pain intensity (numeric rating scale, 0-10; whereby 0 indicated no pain and 10 indicated worst pain imaginable) measured 3 months after the intervention. The prespecified minimal clinically important difference was defined as 2 points or more. Final follow-up was at 12 months, ending October Results: Among 681 participants who were randomized (mean age, 52.2 years; 421 women [61.8%], mean baseline pain intensity, 7.1), 599 (88%) completed the 3-month follow-up, and 521 (77%) completed the 12-month follow-up. The mean difference in pain intensity between the radiofrequency denervation and control groups at 3 months was 0.18 (95%CI, 0.76 to 0.40) in the facet joint trial; 0.71 (95%CI, 1.35 to 0.06) in the sacroiliac joint trial; and 0.99 (95%CI, 1.73 to 0.25) in the combination trial. Conclusions and Relevance: In 3 randomized clinical trials of participants with chronic low back pain originating in the facet joints, sacroiliac joints, or a combination of facet joints, sacroiliac joints, or intervertebral disks, radiofrequency denervation combined with a standardized exercise program resulted in either no improvement or no clinically important improvement in chronic low back pain compared with a standardized exercise program alone. The findings do not support the use of radiofrequency denervation to treat chronic low back pain from these sources. GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 17 of 23

18 Appendix 2 Post Consultation Additional Evidence Review Summary Table Radiofrequency Denervation for Back Pain GM004 Post Consultation Additional Evidence Review Summary Table GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 18 of 23

19 Appendix 2 Diagnostic and Procedure Codes Radiofrequency Denervation for Back Pain GM004 (All codes have been verified by Mersey Internal Audit s Clinical Coding Academy) GM004 - Radiofrequency Denervation for Neck and Back Pain OPCS-4 Procedure codes: In accordance with the definition that it is denervation of the facet joint, the relevant codes are: Radiofrequency controlled thermal denervation of spinal facet joint of cervical vertebra V48.1 Radiofrequency controlled thermal denervation of spinal facet joint of thoracic vertebra V48.3 Radiofrequency controlled thermal denervation of spinal facet joint of lumbar vertebra V48.5 Radiofrequency controlled thermal denervation of spinal facet joint of vertebra NEC V48.7 Primary percutaneous intradiscal radiofrequency thermocoagulation to cervical intervertebral disc Primary percutaneous intradiscal radiofrequency thermocoagulation to thoracic intervertebral disc Primary percutaneous intradiscal radiofrequency thermocoagulation to lumbar intervertebral disc Other specified primary percutaneous intradiscal radiofrequency thermocoagulation to intervertebral disc Unspecified primary percutaneous intradiscal radiofrequency thermocoagulation to intervertebral disc Revisional percutaneous intradiscal radiofrequency thermocoagulation to cervical intervertebral disc Revisional percutaneous intradiscal radiofrequency thermocoagulation to thoracic intervertebral disc Revisional percutaneous intradiscal radiofrequency thermocoagulation to lumbar intervertebral disc Other specified revisional percutaneous intradiscal radiofrequency thermocoagulation to intervertebral disc Unspecified revisional percutaneous intradiscal radiofrequency thermocoagulation to intervertebral disc V62.1 V62.2 V62.3 V62.8 V62.9 V63.1 V63.2 V63.3 V63.8 V63.9 With the following ICD-10 diagnosis code(s): Radiculopathy M54.1 Cervicalgia M54.2 Sciatica M54.3 Lumbago with sciatica M54.4 GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 19 of 23

20 Low back pain M54.5 Pain in thoracic spine M54.6 Other dorsalgia M54.8 Dorsalgia, unspecified M54.9 Exceptions (ICD-10): Pregnancy related codes All codes with the first three characters between O00- O99, Z34, Z33.X Comorbidities this is too broad a description as could cover a multitude of codes GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 20 of 23

21 Appendix 3 Version History Radiofrequency Denervation for Back Pain GM004 The latest version of this policy can be found here: GM Radiofrequency Denervation for Back Pain policy Version Date Summary of Changes /03/2015 Initial draft /09/2015 On the 16 th September 2015 the EUR Steering Group agreed the following changes to the policy: Under section 4 Criteria for Commissioning the Mandatory Criteria was updated to read as follows: 'Radiofrequency Denervation is commissioned if the provider is using Thermo-coagulation Radiofrequency Denervation and this is undertaken by experience clinicians using the correct technique within an environment suitable for delivery of this procedure and all appropriate back up is available. Pulsed Radiofrequency Denervation is not commissioned. Radiofrequency Denervation is commissioned for individuals who meet the following criteria: there should be no other treatment option available for the patient OR alternative treatments such as analgesic medication are intolerable or produce undesirable side effects OR the patient has demonstrated failure to respond to, or had a loss of response to other treatment options OR Other treatment options are contraindicated and this is clearly documented Prior to consideration for Radiofrequency Denervation the patient should: Have previously engaged with and complied with the advice / treatments advised by specialist pain management services Have a history of chronic, function-limiting pain of at least 12 months duration Show a good response to comparative double diagnostic blocks o consider Sacroiliac Joint Radiofrequency Denervation for patients who respond with at least 80% pain relief after fluoroscopy guided diagnostic sacroiliac joint injections o use the period of pain relief to rehabilitate the patient in close cooperation with other specialities Patients should not have Radiofrequency Denervation if: they are pregnant or breast feeding there are any comorbidities present that contraindicate Radiofrequency Denervation they are unable to be positioned in the correct way prior to treatment Following Radiofrequency Denervation and where clinically appropriate the patient should be referred for and participate in active rehabilitation. In addition, wherever possible, patients should be encouraged to: participate in mobilisation or rehabilitation therapy take effective pain relief medication where indicated (and where it is available) be referred for weight management support.' GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 21 of 23

22 1.0 18/11/2015 On the 18 th November 2015 the GM EUR Steering Group approved the changes made to the policy on the 16 th September 2015 and requested the following additional changes be made: Clarity on what is meant by comparative double diagnostic blocks, added under the mandatory criteria section as follows: 'Show a good response to comparative double diagnostic blocks (i.e. shows a good response to two consecutive diagnostic facet joint injections) NOTE: Patients who have had prior approval for double diagnostic blocks are considered to already have prior approval for Radiofrequency Denervation if the response to both injections is positive.' Repeat Radiofrequency Denervation criteria added to the Mandatory Criteria section of the policy as follows: 'Patients requiring repeat Radiofrequency Denervation will need an application for prior approval with one of the following: where Radiofrequency Denervation has failed in the first instance - a clear statement as to why previous Radiofrequency Denervation failed and steps to be taken to avoid subsequent failure of Radiofrequency Denervation: where repeat Radiofrequency Denervation is needed due to nerve regeneration - a summary of the length of relief gained with an assurance that subsequent treatment is expected to gain similar results.' Funding Mechanism in the policy has been amended to read as follows: 'Funding for Radiofrequency Denervation for neck and back pain will be Individual Prior Approval. Funding approval should be obtained via the Individual Funding Request route prior to referral. Where Individual Prior Approval has already been given for 2 diagnostic facet joint injections in those cases individuals are already consider to have prior approval for Radiofrequency Denervation provided both injections gave a positive response. Funding for other patients may be considered on an individual patient basis, if there is evidence of clinically exceptional circumstances.' Post Consultation additional Evidence Review Summary Table added as Appendix 2 Subject to the above amendments being made the GM EUR Steering Group approved the policy to go through the governance process. 15/03/2016 Report updated to Greater Manchester Shared Services template and references to North West Commissioning Support Unit changed to Greater Manchester Shared Services. Wording for date of review amended to read: 'One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years)' on Policy Statement and section 13. Date of Review /07/2016 Diagnostic and Procedure Codes added as Appendix /09/2016 Commissioning Recommendation & Mandatory Criteria The GM EUR Steering Group agreed to add the following bullet point under Prior to consideration for Radiofrequency Denervation the patient should : 'OR The clinical diagnosis is clear and the patient has shown a good response to a single diagnostic block' Funding mechanism amended to reflect the above addition. GM Radiofrequency Denervation for Back Pain Policy v2.1 FINAL Page 22 of 23