Management of chronic pain associated with temporomandibular disorders: a clinical practice guideline
BMJ 2023; 383 doi: https://doi.org/10.1136/bmj-2023-076227 (Published 15 December 2023) Cite this as: BMJ 2023;383:e076227Linked Editorial
Chronic pain associated with temporomandibular disorders
Linked Research
Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials
- Jason W Busse, professor, methods co-chair123,
- Rodrigo Casassus, associate professor, clinical co-chair4,
- Alonso Carrasco-Labra, associate professor5,
- Justin Durham, professor6,
- David Mock, professor and dean emeritus7,
- Joanna M Zakrzewska, professor8,
- Carolyn Palmer, dentist9,
- Caroline F Samer, pharmacologist, associate professor1011,
- Matteo Coen, general internist1213,
- Bruno Guevremont, patient partner14,
- Thomas Hoppe, patient partner14,
- Gordon H Guyatt, distinguished professor2,
- Holly N Crandon, MSc candidate15,
- Liang Yao, PhD candidate2,
- Behnam Sadeghirad, assistant professor23,
- Per O Vandvik, general internist, associate professor16,
- Reed A C Siemieniuk, general internist, methodologist2,
- Lyuba Lytvyn, patient liaison expert2,
- Birk Stokke Hunskaar, PhD candidate16,
- Thomas Agoritsas, general internist, associate professor21217
- 1Michael G DeGroote National Pain Centre, McMaster University, Hamilton ON, Canada
- 2Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton ON, Canada
- 3Department of Anesthesia, McMaster University, Hamilton ON, Canada
- 4Orofacial Pain Unit, Maxillo-Facial Department, Clínica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile
- 5Center for Integrative Global Oral Health, University of Pennsylvania, School of Dental Medicine, Philadelphia PA, USA
- 6School of Dental Sciences, Newcastle University, UK
- 7Faculty of Dentistry and Mount Sinai Hospital, University of Toronto, Canada
- 8Royal National ENT &Eastman Dental Hospitals University College London Hospitals, London, UK
- 9Veterans Affairs Canada, Charlottetown, PE, Canada
- 10Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals
- 11Faculty of Medicine, University of Geneva, Switzerland
- 12Division of General Internal Medicine, Department of Medicine, University Hospitals of Geneva, Geneva, Switzerland
- 13Unit of Development and Research in Medical Education, Faculty of Medicine, University of Geneva, Geneva, Switzerland
- 14The Canadian Veterans Chronic Pain Centre of Excellence, Hamilton, ON, Canada
- 15Faculty of Health Sciences, McMaster University, Hamilton, Canada
- 16Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway
- 17The MAGIC Evidence Ecosystem Foundation, Oslo, Norway
- Correspondence to: J W Busse bussejw{at}mcmaster.ca
Abstract
Clinical question What is the comparative effectiveness of available therapies for chronic pain associated with temporomandibular disorders (TMD)?
Current practice TMD are the second most common musculoskeletal chronic pain disorder after low back pain, affecting 6-9% of adults globally. TMD are associated with pain affecting the jaw and associated structures and may present with headaches, earache, clicking, popping, or crackling sounds in the temporomandibular joint, and impaired mandibular function. Current clinical practice guidelines are largely consensus-based and provide inconsistent recommendations.
Recommendations For patients living with chronic pain (≥3 months) associated with TMD, and compared with placebo or sham procedures, the guideline panel issued: (1) strong recommendations in favour of cognitive behavioural therapy (CBT) with or without biofeedback or relaxation therapy, therapist-assisted mobilisation, manual trigger point therapy, supervised postural exercise, supervised jaw exercise and stretching with or without manual trigger point therapy, and usual care (such as home exercises, stretching, reassurance, and education); (2) conditional recommendations in favour of manipulation, supervised jaw exercise with mobilisation, CBT with non-steroidal anti-inflammatory drugs (NSAIDS), manipulation with postural exercise, and acupuncture; (3) conditional recommendations against reversible occlusal splints (alone or in combination with other interventions), arthrocentesis (alone or in combination with other interventions), cartilage supplement with or without hyaluronic acid injection, low level laser therapy (alone or in combination with other interventions), transcutaneous electrical nerve stimulation, gabapentin, botulinum toxin injection, hyaluronic acid injection, relaxation therapy, trigger point injection, acetaminophen (with or without muscle relaxants or NSAIDS), topical capsaicin, biofeedback, corticosteroid injection (with or without NSAIDS), benzodiazepines, and β blockers; and (4) strong recommendations against irreversible oral splints, discectomy, and NSAIDS with opioids.
How this guideline was created An international guideline development panel including patients, clinicians with content expertise, and methodologists produced these recommendations in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation (MAGIC) provided methodological support. The panel approached the formulation of recommendations from the perspective of patients, rather than a population or health system perspective.
The evidence Recommendations are informed by a linked systematic review and network meta-analysis summarising the current body of evidence for benefits and harms of conservative, pharmacologic, and invasive interventions for chronic pain secondary to TMD.
Understanding the recommendation These recommendations apply to patients living with chronic pain (≥3 months duration) associated with TMD as a group of conditions, and do not apply to the management of acute TMD pain. When considering management options, clinicians and patients should first consider strongly recommended interventions, then those conditionally recommended in favour, then conditionally against. In doing so, shared decision making is essential to ensure patients make choices that reflect their values and preference, availability of interventions, and what they may have already tried. Further research is warranted and may alter recommendations in the future.
Our recommendations are based on a linked systematic review and network meta-analysis (see box 1).1 The infographic provides the recommendations together with an overview of the absolute benefits and harms of interventions for chronic pain associated with temporomandibular disorders in the standard GRADE format. Clinicians and their patients can find consultation decision aids to facilitate shared decision-making in MAGICapp (https://app.magicapp.org/#/guideline/EQ305L).
Linked articles in this BMJ Rapid Recommendations cluster
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Busse JW, Casassus R, Carrasco-Labra A, et al. Management of chronic pain associated with temporomandibular disorders: a clinical practice guideline. BMJ 2023;383:e076227 doi:10.1136/bmj-2023-076227
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Yao L, Sadeghirad B, Li M, et al. Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials. BMJ 2023;383:e076226. doi:10.1136/bmj-2023-076226
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Review of randomised trials that assessed interventions for chronic pain associated with temporomandibular disorders
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MAGICapp (https://app.magicapp.org/#/guideline/EQ305L). Expanded version of the results with multilayered recommendations, evidence summaries, and decision aids for use on all electronic devices
Current practice
Temporomandibular disorders (TMD) can cause pain in the jaw, face, and neck, and may present with headaches, earache, clicking, popping, or crepitus in the temporomandibular joint, and impaired mandibular function.2 In 2014, the International Network for Orofacial Pain and Related Disorders Methodology (INFORM) group updated their diagnostic criteria to include 12 subtypes of TMD,3 4 the most prevalent of which is myalgia.5 However, diagnostic criteria for each subtype are largely based on subjective findings, and it is common for patients to satisfy criteria for more than one subtype.6 7 8 In 2017, the US National Institutes of Health acknowledged: “There is no widely accepted, standard test now available to correctly diagnose TMJ [temporomandibular joint] disorders.”9
Up to 30% of acute TMD may become chronic (≥3 months in duration),10 11 and women are more likely to be affected than men.12 The prevalence of chronic TMD pain ranges from 6% to 9% in the general population,13 and psychological comorbidities are common. A 2022 systematic review, predominantly of patients with chronic TMD attending specialty clinics, found that 43% (95% confidence interval 36% to 50%) presented with (typically moderate) depression and 60% (52% to 67%) with moderate to severe somatisation.14
Chronic TMD share key symptoms with fibromyalgia and chronic fatigue syndrome (such as generalised pain sensitivity, sleep and concentration difficulties, and headache),15 and the International Association for the Study of Pain classifies chronic TMD as a primary pain condition.16 The aetiology of TMD is uncertain, and diagnostic imaging (which is commonly acquired17) can lead to incidental findings that influence treatment decisions: signs of a degenerative joint are often present in the absence of symptoms, and temporomandibular joint disc displacements occur in approximately a third of asymptomatic patients.18 In the absence of pathognomonic features, intervention has focused on symptom management, and removeable occlusal splints have become a popular treatment for chronic TMD pain.19 However, a 2020 systematic review found very low certainty evidence that oral splints were ineffective in reducing pain compared with no or minimal treatment.20
Prognosis of chronic TMD pain is variable. A five year follow-up of 234 of 368 individuals with chronic TMD pain (36% loss to follow-up) found that 49% reported complete recovery, 14% reported >50% pain relief, 8% reported 20-50% pain relief, 13% were unchanged, and 16% reported ≥20% increased pain.21 Improvement in pain was largely independent of changes in clinical signs (such as range of motion), and patients who were pain-free at follow-up reported significantly greater joint sounds than at baseline. Patients who were pain-free at five years endorsed low levels of psychopathology at baseline that remained low at follow-up; however, individuals reporting ≥50% pain relief at five years reported elevated levels of depression, anxiety, and somatisation at baseline that were significantly reduced at follow-up. The OPPERA cohort reported 24% (46 of 189) complete remission of chronic TMD pain at five year follow-up, but it had a 78% (666 of 855) loss to follow-up.22 Patients whose symptoms had resolved at follow-up showed significant decreases in pain catastrophising.
Clinical practice guidelines have emerged to support decision making for TMD, but with inconsistent recommendations (table 1) and important limitations in their development. Of the five most recently published guidelines, four do not report the methodology used for their development, and they provide lists of available conservative and invasive treatments for TMD without information on comparative effectiveness or certainty of evidence.20 21 25 27 The exception, the 2018 guideline from the Korea Standard CPG Development Agency, conducted systematic reviews of the literature to identify evidence to inform their recommendations, but only considered Korean medicine treatments. The authors reported use of the GRADE approach to rate the certainty of evidence, but with two problematic modifications; they rated up the certainty of evidence if the intervention was used widely in clinical practice or “when the level of evidence was low, but the benefit seemed obvious and clinically valuable.”26 A systematic assessment of all clinical practice guidelines on diagnosis and management of TMD published up to May 2020, found considerable deficits in the development and reporting among each of them and concluded there was a need for rigorously developed guidelines.28 Similarly, a 2020 report by the US National Academy of Sciences recommended the development of evidence based guidelines for management of TMD.29
The five most recent guidelines for management of temporomandibular disorders (TMD)
People living with chronic pain associated with TMD have several interventions from which to choose, and observational studies have reported high variability in care for similar complaints.30 31 One editorial acknowledged: “any dentist may employ nearly any diagnostic modality or treatment with impunity, regardless of its degree of scientific credibility. Unsuspecting TMD patients may be exposed to simple, conservative and relatively inexpensive treatments or to invasive, irreversible and costly treatments by another – both for the same set of symptoms.”32
How this recommendation was created
Our international guideline development panel—including dentists, general internists, oral surgeons, physicians specialising in orofacial pain management, a clinical pharmacologist, epidemiologists, methodologists, statisticians, and people living with chronic pain secondary to temporomandibular disorders (TMD)—determined the scope of recommendations and the outcomes that are most important to patients. We identified methodologists and clinical experts for our panel through our networks and suggestions from The BMJ and identified patient partners through the Chronic Pain Centre of Excellence for Canadian Veterans. After completion of a systematic review and network meta-analysis on the benefits and harms of available treatments for chronic pain associated with TMD, the panel met online to discuss the evidence and formulate recommendations. No panel member had financial conflicts of interest; intellectual and professional conflicts were minimised and managed (see appendix 1 on bmj.com for details).
We followed the BMJ Rapid Recommendations procedures for creating trustworthy guidance,41 including using the GRADE approach to critically appraise the evidence and create recommendations (appendix 2 on bmj.com).42 Our critical outcome was pain relief. We considered the balance of benefits, harms, and burdens of each intervention, the certainty of the evidence for each outcome, typical and expected variations in patient values and preferences, practical issues related to use and acceptability.43
Recommendations can be strong or conditional, for or against a course of action. For strong recommendations, all or almost all informed individuals would choose the recommended course of action. Strong recommendations typically require a clear imbalance between benefits and harms supported by high or moderate certainty evidence; however, there are five paradigmatic scenarios in which a strong recommendation can be made based on low certainty evidence. One such scenario is when there is low certainty of benefit and moderate to high certainty of greater risk of important harm. For conditional recommendations, most informed individuals would choose the suggested course of action, but an appreciable minority would not, and clinicians should assist patients to arrive at a management decision consistent with their values and preferences. Conditional recommendations are typically made when the benefits and harms of an intervention are closely aligned, or when there is only low or very low certainty of effectiveness.
We required 80% consensus among panel members for strong recommendations, and a majority consensus for conditional recommendations. The consensus process was overseen by two experienced guideline methodologists (JWB, TA). The draft summary of findings were prepared prior to the panel meetings, following GRADE guidance from the accompanying network meta-analysis.1 Interventions were presented sequentially during the panel meetings, starting with those supported by moderate to high certainty of benefit (on pain relief or physical functioning) to lower certainty, and from low to high concerns about harms. This allowed the panel to discuss and group interventions displaying similar benefits and harms together, along with consideration of practical issues and other elements of the evidence to the decision framework42 43 and identify clusters of interventions for each direction and strength of recommendation (strong in favour, conditional in favour, conditional against, strong against).
The evidence
The linked systematic review included 210 studies (in 233 publications), of which 153 trials (8713 participants) were included in network meta-analyses.1 These trials reported the effects of 59 interventions, or combinations of interventions, when compared with placebo or sham procedures in patients with chronic pain associated with temporomandibular disorders (TMD). Studies typically enrolled small numbers of patients with short follow-up, and predominantly included women aged 30-39 years with longstanding chronic TMD pain of moderate severity. Most trials enrolled mixed types of TMD or did not specify which subtypes were included; of those that did provide details, the most commonly enrolled subtype of TMD was myalgia (table 2).
Characteristics of 153 eligible randomised clinical trials (8713 patients) included in the network meta-analysis of interventions for chronic pain associated with temporomandibular disorders (TMD). (Additional details in linked network meta-analysis1)
Our guideline panel identified seven patient-important outcomes to inform their recommendations: (1) pain relief, (2) physical functioning, (3) emotional functioning, (4) role functioning, (5) social functioning, (6) sleep quality, and (7) adverse events. Pain relief was our critical outcome. Because of inadequate reporting of effects on harms among eligible trials, we surveyed the clinical experts on our panel regarding anticipated risks of serious and non-serious adverse events associated with all conservative, pharmacological, and invasive or irreversible therapies identified in our systematic review (see section below on “Absolute benefits and harms”).
Understanding the recommendations
The 59 interventions summarised in the associated network meta-analysis were classified into four sets of recommendations, according to their strength and direction, relative to placebo or sham procedures. As we found moderate to high certainty evidence for important benefits on pain relief (our critical outcome), and the guideline panel was confident that the interventions were not associated with serious harms, we issued strong recommendations in favour of: cognitive behavioural therapy (with or without biofeedback or relaxation therapy), therapist-assisted mobilisation, manual trigger point therapy, supervised postural exercise, supervised jaw exercise and stretching (with or without manual trigger point therapy), and usual care (such as education, home exercises and stretching, self massage, and over-the-counter analgesics). Average effects of these interventions on pain ranged from −1.31 cm to −2.62 cm on a 10 cm visual analogue scale (on which the minimally important difference (MID) is 1 cm).
In contrast, the panel issued strong recommendations against the following interventions with uncertain benefits and the potential for serious harms: irreversible oral splints, discectomy, and non-steroidal anti-inflammatory drugs (NSAIDs) with opioids. The panel justified a strong recommendation based on the paradigmatic scenario outlined in “How the recommendations were created” (that is, low certainty for benefit and confidence that serious harms were possible). Between these two categories, because the evidence for pain relief was only of low or very low certainty and the panel was not confident that remaining interventions were associated with serious harms (see “Absolute benefits and harms”), the panel made conditional recommendations for 46 other interventions or combinations of interventions.
In navigating across these categories of recommendations, clinicians and patients may start by considering those interventions that are strongly recommended, then conditionally in favour, then conditionally against. In doing so, shared decision making is essential to ensure patients make choices that reflect their values and preference, availability of interventions, and what they may have already tried. Effect estimates on pain, physical function, and adverse events for all 59 interventions or combination of interventions are available on MAGICapp (https://app.magicapp.org/#/guideline/EQ305L).
Who does the recommendations apply to?
The recommendations apply to adult patients living with moderate chronic pain (4-6 cm on a 10 cm pain scale for ≥3 months duration) secondary to TMD as a group of conditions. They do not apply to the management of acute TMD pain (<3 months duration). Some treatment effects were rated down due to substantial unexplained heterogeneity, and we cannot rule out the possibility that different subtypes of TMD may benefit more or less from certain interventions.
Many trials eligible for our review excluded TMD patients with comorbid mental illness, fibromyalgia, or rheumatoid arthritis, or those who had previously undergone TMD surgery, and did not report the representation of veterans (who seem to be more prone to developing TMD33) or of individuals receiving disability benefits or engaged in litigation. The generalisability of our recommendations to these populations is therefore uncertain.
Absolute benefits and harms
The infographic explains the recommendations and provides links to MAGICapp with evidence summaries of absolute benefits and harms of interventions for chronic pain secondary to TMD. Estimates of baseline risk for effects come from the control arms of trials eligible for the associated network meta-analysis.1 Trials for most interventions did not report effects on adverse events, and of the 32% (19 of 59) of interventions that did report data on harms, the evidence was almost entirely very low certainty.
We therefore surveyed the clinical experts on our panel regarding the potential harms associated with each intervention. The resulting consensus was that conservative therapies were likely associated with minor harms only (such as temporary stiffness after exercise, bruising after acupuncture), and most pharmacotherapy and supplements assessed were also likely associated with minor harms, except for the combination of long term NSAIDs and opioids that could result in serious harms (for example, gastrointestinal bleeding, addiction, overdose). Our experts felt that most invasive procedures, such as arthrocentesis and trigger point injections, were associated with the possibility of moderate harm (such as local infection), and that discectomy and irreversible splints may result in serious harms (such as permanent change in range of motion, facial nerve weakness).34
The panel was thus confident that, relative to placebo or sham procedures:
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Cognitive behavioural therapy (CBT) augmented with relaxation therapy or biofeedback, therapist-assisted jaw mobilisation, and manual trigger point therapy provide the largest reduction in chronic pain severity associated with TMD, approximating twice the minimally important difference (MID) (GRADE moderate certainty evidence).
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CBT, supervised postural exercise, supervised jaw exercise and stretching with or without manual trigger point therapy, and usual care (such as education, support, home exercises and stretching) provide important, but less relief of chronic pain associated with TMD compared with other available treatments, approximating to 1.5× the MID (GRADE moderate to high certainty evidence).
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It is unlikely that new information will change interpretation for outcomes that are supported by high to moderate certainty of evidence.
The panel was less confident about:
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Whether use of other available therapies improved pain among people living with chronic pain associated with TMD (GRADE very low to low certainty evidence).
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Harms associated with available interventions to manage chronic pain associated with TMD (GRADE very low to low certainty evidence).
Values and preferences
We surveyed our panel using a standardised process for identifying patient values and preferences.35 36 Respondents advised that, overall, people living with chronic pain associated with TMD were likely to accept the typical risks associated with conservative treatments and most pharmacotherapy and supplements for an improvement in pain approximating to the MID (1 cm on a 10 cm visual analogue scale). However, due to the greater risk of moderate or serious harms, patients would likely require an improvement in pain approximating three times the MID with invasive or irreversible procedures. The panel recognised that values and preferences were likely to vary between patients, further highlighting the importance of shared decision.
Practical issues and other considerations
Box 2 outlines the key practical issues for patients and clinicians discussing interventions for chronic pain associated with TMD (further details in MAGICapp plus decision aids to support shared decision making). Most trials (134/153; 88%) that informed the evidence for this guideline were conducted in high- or middle-income countries. Each recommended intervention requires clinician administration and depends on access and patient participation, and may entail costs that are borne by patients. Most trials we reviewed that explored the effectiveness of CBT delivered treatment in person; however, one trial administered therapy via a programme on the internet supported by asynchronous therapist feedback.37 A systematic review of 32 randomised trials found high certainty evidence that therapist-supported, remotely delivered CBT is equally effective to in-person delivery for a range of psychiatric and somatic complaints.38 Remote CBT is also more cost-effective,39 and the World Health Organization Global Oral Health Action Plan has proposed that member states should strengthen access and capacity for using digital technologies to ensure that digital health approaches do not increase inequalities.40
Practical issues concerning interventions for chronic pain associated with temporomandibular disorders (TMD)
Cost and access
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Expense may be a barrier to accessing therapists-delivered care unless patients have private health coverage or reside in a jurisdiction where these services are included in public health care
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Access to cognitive behavioural therapy (CBT) may be facilitated by therapist-supported remote delivery, which is less costly than and likely similarly effective to in-person CBT38 39 44
Patient engagement
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Patient adherence is required for active interventions (such as CBT, supervised exercise): both feasibility and patient preference should be considered when starting a trial of therapy
Adverse effects
Costs and resources
When formulating the recommendations, the guideline panel focused on patients’ perspectives rather than that of society. However, both availability and costs of interventions for chronic pain associated with TMD may influence decision making.
Future research
Key research questions to inform decision makers and future guidelines include:
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Are there systematic differences in treatment effects of interventions based on TMD subtypes?
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Is remote CBT as effective as in-person CBT for chronic pain associated with TMD?
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What are the effects of interventions targeting chronic pain associated with TMD on patient-important outcomes that were poorly reported among trials that informed our evidence synthesis; specifically, physical functioning, role functioning (including return to work), social functioning, mental functioning, sleep quality, and adverse events?
How patients were involved in the creation of this article
Three patients with lived experience of chronic pain associated with TMD were full members of our guideline panel. These panel members identified important outcomes and informed the discussion on values and preferences. Our patient partners agreed that, while several conservative interventions showed important net benefits for pain relief and/or functional improvement, individual patients may prefer some types of interventions over others. Such preferences, as well as cost and access to therapy, should be considered in decision making with patients. These panel members participated in the teleconferences and email discussions and met all authorship criteria.
Education into practice
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Chronic pain associated with temporomandibular disorders (TMD) is common. How might you share these recommendations with colleagues?
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Aside from usual care, there are seven interventions with strong recommendations in favour; however, they all require active participation by patients. What information could you share with your patient to support decision making that considers engagement and adherence?
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Having read the article, can you think of one thing you have learnt which might alter how you consult with patients living with chronic pain associated with TMD?
Acknowledgments
We thank Rachel J Couban, medical librarian, for assistance in identifying guidelines for management of temporomandibular disorders. We thank Will Stahl-Timmins and colleagues at The BMJ for design of the infographic. We thank one of our patient partners, who did not provide written consent to be listed.
Footnotes
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This BMJ Rapid Recommendation article is one of a series that provides clinicians with trustworthy recommendations for potentially practice changing evidence. BMJ Rapid Recommendations represent a collaborative effort between the MAGIC group (www.magicevidence.org) and The BMJ. A summary is offered here and the full version including decision aids is on the MAGICapp (www.magicapp.org), for all devices in multilayered formats. Those reading and using these recommendations should consider individual patient circumstances, and their values and preferences and may want to use consultation decision aids in MAGICapp to facilitate shared decision making with patients. We encourage adaptation and contextualisation of our recommendations to local or other contexts. Those considering use or adaptation of content may go to MAGICapp to link or extract its content or contact The BMJ for permission to reuse content in this article.
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Competing interests: All authors have completed the BMJ Rapid Recommendations interests disclosure form, and a detailed, contextualised description of all disclosures is reported in appendix 1. As with all BMJ Rapid Recommendations, the executive team and The BMJ judged that no panel member had any financial conflict of interest. Personal, professional, and academic interests were minimised as much as possible, while maintaining necessary expertise on the panel to make fully informed decisions.
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Funding: This guideline was funded by the Chronic Pain Centre of Excellence for Canadian Veterans. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. JWB is supported, in part, by a Canadian Institutes of Health Research Canada Research Chair in the prevention and management of chronic pain.
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Transparency: JWB affirms that the manuscript is an honest, accurate, and transparent account of the recommendation being reported; that no important aspects of the recommendation have been omitted; and that any discrepancies from the recommendation as planned (and, if relevant, registered) have been explained.