National Institute for Health and Care Excellence Draft Chronic pain: assessment and management [I] Evidence review for manual therapy NICE guideline Intervention evidence review underpinning the research recommendation in the NICE guideline August 2020 Draft for Consultation This evidence review was developed by the National Guideline Centre Chronic pain: DRAFT FOR CONSULTATION Contents Disclaimer The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian. Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn. Copyright © NICE 2020. All rights reserved. Subject to Notice of rights. ISBN [to be added on publication] Chronic pain: DRAFT FOR CONSULTATION Contents Contents 1 Manual therapies for chronic primary pain ................................................................. 6 1.1 Review question: What is the clinical and cost effectiveness of manual therapy for the management of chronic primary pain? ........................................................ 6 1.2 Introduction ........................................................................................................... 6 1.3 PICO table ............................................................................................................. 6 1.4 Clinical evidence ................................................................................................... 7 1.4.1 Included studies ......................................................................................... 7 1.4.2 Excluded studies ........................................................................................ 7 1.4.3 Summary of clinical studies included in the evidence review ...................... 8 1.4.4 Quality assessment of clinical studies included in the evidence review .... 19 1.5 Economic evidence ............................................................................................. 31 1.5.1 Included studies ....................................................................................... 31 1.5.2 Excluded studies ...................................................................................... 31 1.5.3 Unit costs ................................................................................................. 32 1.6 Evidence statements ........................................................................................... 32 1.6.1 Clinical evidence statements .................................................................... 32 1.6.2 Health economic evidence statements ..................................................... 35 1.7 The committee’s discussion of the evidence ........................................................ 35 1.7.1 Interpreting the evidence .......................................................................... 35 1.7.2 Cost effectiveness and resource use ....................................................... 38 1.7.3 Other factors the committee took into account ......................................... 38 References ......................................................................................................................... 39 Appendices ........................................................................................................................ 61 Appendix A: Review protocols ................................................................................... 61 Appendix B: Literature search strategies ................................................................... 69 B.1 Clinical search literature search strategy ...................................................... 69 B.2 Health Economics literature search strategy ................................................. 76 Appendix C: Clinical evidence selection ..................................................................... 82 Appendix D: Clinical evidence tables ......................................................................... 83 Appendix E: Forest plots .......................................................................................... 131 E.1 Mixed modality manual therapy vs. Usual care ........................................... 131 E.2 Soft tissue technique vs. usual care............................................................ 132 E.3 Manipulation/mobilisation vs. usual care ..................................................... 134 E.4 Mixed modality manual therapy vs. soft tissue techniques .......................... 135 E.5 Mixed modality manual therapy vs. manipulation/mobilisation .................... 136 E.6 Manipulation/mobilisation vs. soft tissue techniques ................................... 136 E.7 Mixed modality manual therapy vs. acupuncture/dry needling .................... 138 E.8 Soft tissue techniques vs. acupuncture/dry needling .................................. 138 4 Chronic pain: DRAFT FOR CONSULTATION Contents E.9 Manipulation/mobilisation vs. acupuncture/dry needling ............................. 139 Appendix F: GRADE tables ..................................................................................... 140 Appendix G: Health economic evidence selection .................................................... 150 Appendix H: Health economic evidence tables ........................................................ 152 Appendix I: Excluded studies.................................................................................. 153 I.1 Excluded clinical studies ............................................................................. 153 I.2 Excluded health economic studies .............................................................. 159 Appendix J: Research recommendations ................................................................ 160 Appendices ...................................................................................................................... 162 Appendix K: MIDs for continuous outcomes ............................................................. 162 5 Chronic pain: DRAFT FOR CONSULTATION Manual therapies for chronic primary pain 11 Manual therapies for chronic primary pain 1.12 Review question: What is the clinical and cost 3 effectiveness of manual therapy for the management of 4 chronic primary pain? 1.25 Introduction 6 Manual therapy is often used to treat neurological, cardio-respiratory and orthopaedic 7 conditions, including pain. The practitioner delivering the therapy applies mechanical forces 8 to the musculoskeletal structures, usually using the hands, in order to alter the physical 9 and/or neurophysiological properties of the tissues. 10 Modern day manual therapy has been defined as: “the use of hands ……or a hands-on 11 technique with therapeutic intent”.166 It is usually delivered as a therapeutic approach by a 12 range of clinicians including physiotherapists, occupational therapists, osteopaths, 13 chiropractors and massage therapists. 14 There are many different techniques that may be used within manual therapy, and these 15 include: 16 • Soft Tissue Techniques: Mobilisation of tissues such as muscles, tendons, or ligaments, 17 without causing movement or change of joint position for example massage, muscle 18 energy technique, myofascial/trigger point release. 19 • Traction: Manual distraction of a body part, for example the neck. 20 • Manipulation and Mobilisation: Manual techniques specifically applied to joints. 21 Manipulation is application of a high velocity, low amplitude force near end of range of 22 joints. This is often, but not always, accompanied with a pop or click. Mobilisation is 23 passive movement of joints aimed to reduce pain and/or restore range. 24 • Mixed Modality Manual Therapy: A combination of the above techniques. 25 One stated outcome of manual therapy is pain relief, however uncertainty exists regarding 26 this outcome for people with chronic primary pain. This chapter aims to explore the 27 effectiveness of manual therapy techniques as a treatment for the management of chronic 28 primary pain conditions. 1.329 PICO table 30 For full details see the review protocol in appendix A. 31 Table 1: PICO characteristics of review question Population People, aged 16 years and over, with chronic primary pain (whose pain management is not addressed by existing NICE guidance) (chronic