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The Cochrane Database of Systematic Reviews logoLink to The Cochrane Database of Systematic Reviews
. 2021 Aug 22;2021(8):CD014691. doi: 10.1002/14651858.CD014691

Non‐pharmacological and non‐surgical treatments for low back pain in adults: an overview of Cochrane Reviews

Aidan G Cashin 1,2,, Rodrigo RN Rizzo 2,3, Benedict M Wand 4, Neil E O'Connell 5, Hopin Lee 6,7, Matthew K Bagg 2, Edel O'Hagan 1,2, Christopher G Maher 8,9, Andrea D Furlan 10, Maurits W Tulder 11, James H McAuley 2,3
Editor: Cochrane Back and Neck Group
PMCID: PMC8407080

Objectives

This is a protocol for a Cochrane Review (overview). The objectives are as follows:

1. Provide accessible, high‐quality evidence on the effects of non‐pharmacological interventions for people with LBP.
2. To highlight areas of remaining uncertainty and gaps in the evidence regarding the effects of non‐pharmacological interventions for people with LBP.

Background

Description of the condition

Low back pain (LBP) is the most common musculoskeletal condition globally and is the leading cause of years lived with disability (Abbafati 2020). The ageing and growing population is contributing to a rapid increase in the number of people experiencing LBP‐related disability and a significant financial impact on healthcare and support systems (Buchbinder 2018; Cieza 2020). In the USA, LBP was responsible for the highest health care spending across 154 health conditions, with an estimated annual cost of $134.5 billion (95% CI, $122.4‐$146.9 billion) (Dieleman 2020).

Only rarely can a specific cause of LBP (e.g., fracture, epidural abscess, malignancy, cauda equina syndrome, radiculopathy or spinal canal stenosis) be reliably identified, and most LBP is termed ‘non‐specific’ (Hancock 2007; Maher 2017). Most acute episodes of non‐specific LBP improve substantially within the first six weeks, even with minimal intervention (Costa 2012). However, up to 40% of people continue experiencing symptoms beyond three months (Henschke 2008), referred to as chronic non‐specific LBP (van Tulder 2006). LBP can be intermittent and recurring, with around 30% of people who recover from LBP experiencing recurrence within the first year (Da Silva 2017).

Clinical practice guidelines recommend using a biopsychosocial framework to inform non‐specific LBP treatment; acknowledging the interaction of biological, psychological and social factors in shaping the LBP experience (Foster 2018; Hartvigsen 2018). Recently, recommendations have reduced emphasis on pharmacological and surgical interventions and shifted to encourage non‐pharmacological interventions such as self‐management, complementary medicine, and physical and psychological therapies as first‐line treatment options for LBP (Foster 2018).

Description of the interventions

Non‐pharmacological and non‐surgical approaches refer to interventions that do not involve the use of medications, injections or surgeries to treat LBP. For brevity we will use the term, non‐pharmacological, to cover both types of treatments in this review. Non‐pharmacological interventions for LBP include (1) acupuncture and dry needling, (2) education and advice, (3) the use of assistive materials, (4) electrophysical modalities, (5) exercise programs, (6) heat and cold therapies, (7) manual therapy approaches, and (8) psychological therapies (Chou 2017; van Middelkoop 2011). Non‐pharmacological interventions can be delivered as a stand‐alone intervention and as a multimodal intervention such as in combination with a pharmacological intervention (e.g., exercise and paracetamol) or another non‐pharmacological interventions (e.g., exercise and manual therapy).

The choice of non‐pharmacological intervention is influenced by a range of factors including the health professionals’ skills, patients’ and health professionals’ knowledge, preference and access to resources (Balagué 2012; Poder 2019; Widerström 2019). The non‐pharmacological management of LBP generally aims to improve pain, function, mental health and social participation impacted by the condition (Maher 2017), although the specific aims may vary by type of intervention. In addition, many non‐pharmacological interventions share a common aim to empower the individual with LBP towards self‐management and reduced reliance on the healthcare system, particularly pharmacological and surgical interventions.
We will focus this Overview of Cochrane Reviews on non‐pharmacological interventions used to improve pain and physical function in people with LBP.

How the intervention might work

The mechanisms by which different non‐pharmacological interventions might improve pain and function are often not fully understood and differ across interventions (Lee 2016; Wun 2021). We present below commonly proposed mechanism(s) for each class of non‐pharmacological interventions, listed in alphabetical order:

Acupuncture and dry needling

Acupuncture and dry‐needling involve the insertion of a one or more needles at specific parts of the body in order to create analgesic effects (Mu 2020). Acupuncture commonly includes manual stimulation of the needles or stimulation may be applied with electrical current, heat lamps, and moxibustion (a herb burned at the end of the needle) (Lao 1996). Dry‐needling involves the insertion of a needle in the myofascial tissue to deactivate supposed myofascial trigger points. There are various claims and theories regarding the potential therapeutic mechanism of acupuncture and dry needling. These include physiological mechanisms (e.g. pain gate mechanisms, the activation of descending inhibitory neural pathways, specific local actions on putative muscle “trigger points”) (Melzack 1981), and explanations based on traditional Chinese medicine concepts (Andersson 1995).

Advice and Education

Patient education involves the sharing of knowledge or information from the health professional to the patient. Patient education can include information on diagnosis, prognosis and the management of LBP (Furlong 2020; Traeger 2015). Patient education may also involve the provision of more complex information such as teaching patients about the anatomy of the back (Heymans 2004), the neurobiology of pain (Moseley 2015), or the interaction between thoughts, feelings and behaviours (Hansen 2010). Patient education aims to change patients` attitudes, beliefs, behaviours and motivation that may influence pain and function (Borrell‐Carrio 2004; Furlong 2020).

Assistive materials

Assistive materials involve the use of devices to change the posture of the body and/or adapt the worker to the work environment (e.g., lumbar braces, insoles, manual handling aids) (Verbeek 2011). The use of assistive materials in the treatment of LBP are assumed to reduce pain and disability by limiting spinal movement, and relieving load and strain on the back (Verbeek 2011), although the putative mechanisms of action are still debated (Van Duijvenbode 2008).

Electrophysical modalities

Electrophysical modalities involve the use of electrical, magnetic, and light energy as a medical treatment for LBP and examples include transcutaneous electrical nerve stimulation (TENS), interferential therapy, non‐invasive brain stimulation, electromagnetic field therapy or laser therapy (Milne 2001; O'Connell 2010; van Middelkoop 2011). The use of TENS has been proposed to alter the excitability of peripheral nociceptors, stimulate inhibitory interneurons in the spinal cord, and activate supraspinal descending inhibitory neural pathways (Vance 2014). Brain stimulation techniques seek to modulate activity in the areas of the brain that are involved in pain processing (O'Connell 2010). Low‐level laser therapy is proposed to reduce pain by modulating peripheral neurotransmitters, exerting anti‐inflammatory effects and reducing muscle spasm of the back (Yousefi‐Nooraie 2008).

Exercise

Exercise is a planned, structured and repetitive physical activity intended to improve or maintain one or more components of physical fitness (Caspersen 1985). Different types of exercises have been used for the management of LBP such as stretching, strengthening and motor control training for the spine; general resistance training; aerobic exercise; Pilates, Yoga; Tai Chi; water‐based exercises; graded exercise or a combination of two or more types of exercises (multimodal approaches) (Owen 2020). The mechanisms through which exercise improves pain and function may depend on the type of exercise (Smith 2019; Wun 2021). These include improving flexibility, strength, endurance, motor control, and performance on certain activities (Hodges 2003; Rainville 2004); modulating central nervous system activity and the immune system function (Sluka 2018); and targeting psychosocial factors (e.g. fear, self‐efficacy, and worries) commonly associated with the LBP experience (Sluka 2018).

Heat and cold therapy

Heat and cold therapy aim to modulate the temperature of body tissues for LBP management. Heat therapy includes superficial and deep tissues heating and is assumed to decrease stiffness, reduce muscle spasms, increase blood flow and reduce inflammation (Lewis 2012). Examples of superficial heating include hot water bottles, heated stones and heat wraps, and examples of deep heating include microwave diathermy and therapeutic ultrasound (Ebadi 2020; French 2006). Cold therapy uses ice, cold towels or cold gel packs to reduce the temperature of the tissues, aiming to decreases pain through reduction on inflammation, oedema and nerve conduction velocity (Algafly 2007; French 2006).

Manual therapy

Manual therapy involves passive movements applied by health professionals intended to benefit musculoskeletal and neurophysiological systems (Bishop 2015). Several manual therapy techniques have been proposed for the management of LBP including manipulation and mobilisation, mechanical or manual traction, massage, and neural mobilisation. Manipulation and mobilization are expected to work via biomechanical (e.g., reduced internal mechanical stress and improve spinal range of motion) and neurophysiological (e.g., pain gate mechanisms and motor control system) mechanisms (Bialosky 2009; Rubinstein 2019). Mechanical or manual traction has been claimed to increase intervertebral space, inhibit nociception impulses, increases mobility, reduces mechanical stress, and revert dysfunctional neuromuscular reflex patterns (Clarke 2006). Massage therapies (e.g. deep tissue, trigger point) intend to improve circulation, decrease muscle spasm, provide muscle relaxation and increase range of motion (Bialosky 2009). Neural mobilisation combines movements of the spine and extremities aimed to improve range of motion, decrease sensitivity and restore homeostasis in the nervous system (Coppieters 2008).

Psychological therapies

Psychological therapies are a broad family of therapies and techniques designed to target psychosocial factors associated with LBP (e.g. fear, distress, self‐efficacy) (Hoffman 2007). Several psychological therapies are used to treat LBP (Pincus 2013) with common treatment programs originating from a behavioural or cognitive‐ behavioural tradition of clinical psychology (Williams 2020). Psychological and psychologically informed interventions focus on the learning influences that shape and maintain current behaviour (Williams 2020), and may work through common or different mechanisms to change pain and improve function including changes in maladaptive pain‐related cognitions, cognitive flexibility, pain self‐efficacy and pain reactivity (Burns 2016).

Why it is important to do this overview

Non‐pharmacological interventions are recommended as first line care for LBP (Foster 2018; Oliveira 2018). There are many non‐pharmacological interventions available to healthcare professionals with different training and expertise (Ahern 2019). People with LBP, clinicians, researchers and health policymakers require accessible, high‐quality information on the strength of the evidence for efficacy, effectiveness and safety of non‐pharmacological interventions for making informed healthcare decisions (Chou 2018, Chou 2018a; Gopalakrishnan 2013; Lim 2019). Cochrane reviews have investigated the effects of non‐pharmacological interventions and are available to decision‐makers through the Cochrane Library. However, there are multiple overlapping reviews, of varying recency, scope and methodology. This may inhibit decision‐makers’ access and use of this evidence.

There is a need to systematically synthesise this evidence into a single accessible overview for research consumers. We expect that the Overview will improve access to high‐quality information and will describe the non‐pharmacological evidence‐base, including evidence gaps, for treating LBP (Hunt 2018). We aim to co‐publish a distilled version of the review in a peer‐reviewed medical journal to increase exposure to the review.

Objectives

1. Provide accessible, high‐quality evidence on the effects of non‐pharmacological interventions for people with LBP.
2. To highlight areas of remaining uncertainty and gaps in the evidence regarding the effects of non‐pharmacological interventions for people with LBP.

Methods

This overview will be conducted with respect to Chapter V (Overview) of the Cochrane Handbook for Systematic Reviews of Interventions (second edition) (Higgins 2019).

Criteria for considering reviews for inclusion

Types of studies

We will include systematic reviews of randomised controlled trials published in the Cochrane Library. We will exclude reviews that include randomised and non‐randomised designs unless the data for the randomised designs are available separately. We will note and otherwise exclude Cochrane systematic reviews withdrawn from the Cochrane Library. We will verify the inclusion criteria of the included systematic reviews, if necessary, by contacting the authors of these reviews.

Types of participants

We will include systematic reviews that include trials of adults, 18 years or older, with non‐specific LBP (e.g., non‐radicular LBP with or without non‐specific degenerative changes) of any duration (Maher 2017). LBP is defined as a primary area of pain between the twelfth rib and gluteal fold, with or without associated leg pain (Koes 2007). We will exclude systematic reviews that include trials of participants with mixed pain conditions or participants with LBP caused by spinal stenosis (back and leg pain associated with narrowing of the spinal canal), known structural or pathological processes (e.g. nerve root compression, fractures, infection, neoplasm, metastasis) or specific health conditions (e.g. pregnancy, inflammatory disease) (Koes 2007; Maher 2017) unless results for non‐specific LBP are reported separately. We will exclude reviews that include studies of participants younger than 18 years unless they report separate results for the studies of participants 18 years or older.

Types of intervention and comparison

We will include systematic reviews that include trials of non‐pharmacological interventions, used with the intent to improve pain and function, for people with LBP. We will include systematic reviews that include trials evaluating comparisons between non‐pharmacological interventions and (1) placebo/sham interventions (efficacy comparisons), (2) no intervention (including waiting list control and continuation of usual care), or (3) other interventions (effectiveness comparisons). We will also include systematic reviews that include trials evaluating the combination of two non‐pharmacological interventions versus one non‐pharmacological interventions alone. This will include multimodal interventions that do not include an invasive component. We will exclude reviews of pharmacological, injection and surgical interventions to treat LBP unless used as a comparison or standardised across both groups.

Types of outcomes measure

The outcomes for this overview reflect the core outcome set for non‐specific LBP (Chiarotto 2015) and recommendations of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (Dworkin 2005). We make no restriction on time of measurement. We will group outcomes into a short‐term (≤3 months post randomisation) period, an intermediate‐term (>3 months and <12 months post randomisation) period, and a long‐term (≥12 months post randomisation) period. We will include the outcome measure closest to the midpoint of the period in cases where outcome data are available for multiple time points within a period. We will exclude systematic reviews that do not report the primary and secondary outcomes of interest, and systematic reviews where the outcomes are incidence or recurrence of LBP.

Primary outcomes

1. Pain, defined as pain intensity, measured on a continuous self‐report scale (e.g., a visual analogue scale (VAS), numerical rating scale (NRS), the brief pain inventory (BPI) or other validated measure), or in dichotomous format (e.g., as the proportion of participants in each group who attained a predetermined threshold of improvement).

2. Physical function, defined as back pain related function, measured through continuous self‐report scales (e.g., Roland‐Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI)), functional testing protocols or other validated quantitative measures.

3. Safety, defined as adverse effects including amongst others, incidence and severity of adverse effects, trial withdrawal due to adverse effects and incidence of serious adverse effects as described by the systematic review.

Secondary outcomes

1. Participant ratings of improvement, defined as global perceived effect, measured with a validated tool.

2. Health‐related quality of life as measured by a validated tool e.g., the 36‐Item Short Form Health Survey (SF‐36).

3. Workplace participation, measured with days to return‐to‐work, days of absenteeism or days of reduced work activities.

Search methods for identification of reviews

Electronic searches

We will search the Cochrane Database of Systematic Reviews (The Cochrane Library) using a combination of Medical Subject Headings (MeSH) and keywords (Appendix 1), without restriction. We will manage citations using EndNote and Covidence.

Data collection and analysis

Selection of reviews

Two authors (RRNR and AGC or BMW) will independently screen the title and abstract of each citation against the inclusion criteria. We will obtain the full texts of reviews meeting these criteria and screen them again to confirm inclusion. Disagreements will be resolved through discussion, or recourse to a third author (JHM or NOC). Overview authors who are authors of any included reviews will not be involved in decisions involving those reviews. We will document instances where multiple reviews are identified for the same intervention, and instances where primary studies are included in multiple reviews (Pieper 2014). We will describe the selection process in an adapted PRISMA flow chart (Moher 2009).

Data extraction and management

Two overview authors (RRNR and AGC or BMW) will independently extract data using a standardised electronic data extraction form. We will resolve discrepancies through discussion or recourse to a third overview author (JHM or NOC). Overview authors who are authors of any included reviews will not be involved in this process. We will request additional information from the included review authors, where necessary, up to three times over six weeks. We will extract the description of the results in cases where statistical results are not available. We will extract the review characteristics for each LBP symptom duration separately in cases where the included review reports separate data for participants with different LBP symptom duration (e.g. participants with non‐chronic and chronic LBP).

We will extract the following data from each review:

  • Review Characteristics:

    • Objectives of the review

    • Dates of publication, most recent search and planned update

  • Statistical summaries:

    • Point estimates, 95% confidence intervals (CIs) and accompanying measures of heterogeneity for the pooled estimates of intervention effects; for all eligible comparisons at all available time‐points (e.g., risk ratios (RRs), risk difference (RD), odds ratios (ORs), number needed to treat to benefit (NNTB) or harm (NNTH), mean differences (MDs), standardised mean difference (SMDs))

    • Results of responder analyses for pain, including pre‐specified criteria for response and power calculation

Assessment of methodological quality of included reviews

Quality of included reviews

We will use the AMSTAR‐2 (A MeaSurement Tool to Assess systematic Reviews) instrument (Shea 2017) to assess methodological quality of the included reviews. The 16 items in the AMSTAR‐2 instrument provide a broad assessment of systematic review quality that, taken together, inform a judgement of confidence in the review findings. We will develop this judgement using the proposed AMSTAR‐2 scheme, with particular consideration of the seven items (protocol registered before commencement of the review (item 2), adequacy of the literature search (item 4), justification for excluding individual studies (item 7), risk of bias from individual studies being included in the review (item 9), appropriateness of meta‐analytical methods (item 11), consideration of risk of bias when interpreting the results of the review (item 13), assessment of presence and likely impact of publication bias (item 15)) that may critically affect the validity of a review (Shea 2017). Two independent reviewers (RRNR and AGC or BMW) will assess items and form judgements of confidence independently and in duplicate for each sampled review. We will resolve discrepancies through consensus or recourse to a third author (JHM or NOC). Overview authors will not be involved in this process for any of the sampled reviews in which they have been involved. We will contact review authors a maximum of three times over six weeks if clarification is required or information is missing.

Risk of bias of primary studies included in reviews

We will report the risk of bias assessments for the primary studies in each included review. We will not repeat or update these assessments. In instances where the Cochrane ROB tool is not used, we will summarise the assessments from alternative tools and methods used, including details regarding dimensions assessed (e.g., allocation concealment, participant blinding), and results of the assessments (Bialy 2011; Foisy 2011).

Certainty of evidence in included reviews

We will report, where available, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) (Balshem 2011) judgement of certainty for each core comparison for our primary outcomes. The GRADE approach uses five considerations (risk of bias, consistency of effect, imprecision, indirectness and publication bias) to assess the certainty of the body of evidence for each outcome. Two overview authors (RRNR and AGC or BMW) will use a checklist to independently conduct GRADE assessments of certainty in the evidence quality where this has not occurred in the included reviews and the required information is available (Meader 2014). We will resolve discrepancies through consensus, or recourse to a third author (JHM or NOC). GRADE judgements indicate the following degree of certainty in the conclusions of the systematic review:
High: very certain that the true effect lies close to that of the estimate of the effect
Moderate: moderately certain in the effect estimate ‐ the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low: certainty in the effect estimate is limited ‐ the true effect may be substantially different from the estimate of the effect
Very Low: very little certainty in the effect estimate and the true effect is likely to be substantially different from the estimate of the effect
We will report the approach used and the assessments of the certainty of the evidence, where included reviews have used alternate tools to GRADE.

Data synthesis

Data from each review will be presented for each primary and secondary outcome in order of certainty (i.e., high certainty evidence first, followed by moderate certainty evidence, etc.); for efficacy (intervention vs placebo) comparisons, followed by effectiveness comparisons; at each level of follow up (i.e., short term, followed by intermediate term, etc.). We expect the judgement of certainty in the intervention effect to be a GRADE rating in the majority of cases. We will only present narrative descriptions of results where statistical outcome data are not available. Data will be stratified by duration of LBP symptoms: non‐chronic (0 to 12 weeks); chronic (> 12 weeks), mixed (multiple symptom durations grouped together without separate data) and unclear (symptom duration not reported).

We will not perform any statistical synthesis of data or make any informal indirect comparisons on evidence presented from two or more reviews of different interventions that share a common comparator. We will convert effect sizes, where possible, to common scales to facilitate interpretation (e.g., measures of pain intensity on continuous scales will be converted to a common 0‐100 scale). If available, we will present effects on dichotomous outcomes as relative risks and risk differences with 95% CIs that can be converted to the number needed to treat to benefit and the number needed to treat to harm. The comparisons presented will be limited to the data available in the included reviews.

In interpreting effects on pain intensity, we will consider a ≥ 10 point difference in pain intensity on a 0‐100 scale as a minimally important difference, as suggested by the Outcome Measures in Rheumatology (OMERACT) guidelines (Busse 2015). In interpreting reductions in disability, we will convert the scales of the extracted pooled effects to a common 0 to 100 scale and consider a ≥ 10 point reduction in disability as a minimally important difference (Chou 2017).

We plan to present the short‐term efficacy of the intervention compared to placebo on pain intensity in a 'summary of findings’ table (Table 1) as described in Chapter V of the Cochrane Handbook for Systematic Reviews of Interventions (second edition) (Higgins 2019). We will present the results of the remaining primary and secondary outcomes at each time point in an 'overview of reviews’ table (Table 2). We will also include a ‘summary of results’ table (Table 3), as proposed by (McClurg 2016), highlighting the certainty and clinical relevance of the evidence, by considering both the GRADE score and minimally important difference, for the primary outcomes at each time point.

We will ensure that the Overview’s messages are clearly articulated and summarised in the text, highlighting any caution required in interpreting results (Crick 2015; Ioannidis 2008).We will report and discuss methodological strengths and important limitations across the included reviews.

1. Template for a ‘summary of findings’ table.
Non‐pharmacological intervention for [duration] low back pain in adults <3months post intervention (short‐term)
Outcome Intervention and placebo Illustrative comparative risks (95% CI) Relative effect (95% CI) Number of participants (studies) Certainty of the evidence (GRADE) Comments
Assumed risk Corresponding risk
With placebo With intervention
Pain
  Intervention/Placebo #1            
  Intervention/Placebo #2            
  Etc...            

Draft 'summary of findings' table. The table will present the short‐term efficacy of each non‐pharmacological intervention compared to placebo on pain intensity.

2. Template for an ‘overview of reviews’ table (Estcourt 2016; Higgins 2011).
[Intervention] for [duration] low back pain in adults [time point]
Outcome Intervention and Comparison intervention Illustrative comparative risks (95% CI) Relative effect (95% CI) Number of participants (studies) Quality of the evidence (GRADE) Comments
Assumed risk Corresponding risk
With comparator With intervention
Physical function
  Intervention/Comparison #1            
  Intervention/Comparison #2            
  Etc...            
Participant rating of improvement
  Intervention/Comparison #1            
  Intervention/Comparison #2            
  Etc...            
Health‐Related Quality of Life
  Intervention/Comparison #1            
  Intervention/Comparison #2            
  Etc...            
Workplace participation
  Intervention/Comparison #1            
  Intervention/Comparison #2            
  Etc...            
Safety
  Intervention/Comparison #1            
  Intervention/Comparison #2            
  Etc...            

Draft 'overview of reviews' table. Separate tables are planned for each duration of low back pain and follow‐up time point.

3. Template for a 'summary of results' table adapted from McClurg 2016.
  Important difference Small difference (may not be important) Little or no difference Unclear evidence of harm [Clear evidence of harm
High certainty evidence INTERVENTIONS (insert list) which improves/decreases/prevents OUTCOME INTERVENTIONS (insert list) which improves slightly/decreases slighty OUTCOME INTERVENTIONS (insert list) which results in little or no difference in OUTCOME INTERVENTIONS (insert list) which results in unclear evidence of harm in OUTCOME INTERVENTIONS (insert list) which results in clear evidence of harm in OUTCOME
Moderate certainty evidence INTERVENTIONS (insert list) which probably improves/decreases/prevents OUTCOME INTERVENTIONS (insert list) which probably improves slightly/decreases slighty OUTCOME INTERVENTIONS (insert list) which probably results in little or no difference in OUTCOME INTERVENTIONS (insert list) which probably results in unclear evidence of harm in OUTCOME INTERVENTIONS (insert list) which probably results in clear evidence of harm in OUTCOME
Low certainty evidence INTERVENTIONS (insert list) which may improve/decrease/prevent OUTCOME INTERVENTIONS (insert list) which may improve slightly/decreases slighty OUTCOME INTERVENTIONS (insert list) which may result in little or no difference in OUTCOME INTERVENTIONS (insert list) which may result in unclear evidence of harm in OUTCOME INTERVENTIONS (insert list) which may result in clear evidence of harm in OUTCOME
Very low certainty evidence It is uncertain whether INTERVENTION (insert list) improves/decreases/prevents OUTCOME because the certainty of the evidence is low
No data or no studies OUTCOME was not measure or not reported or no studies were found that evaluated the impact of INTERVENTION on OUTCOME

Draft Summary of Results Table. Separate tables are planned for each stated primary outcome at each follow‐up time point. The table will contain only comparisons of efficacy and effectiveness of the intervention. Differences will be scaled according to interpretation in the boundaries of the confidence interval (CI) around the minimal important difference (MID) threshold; important difference where the boundaries of the CI fall completely within the MID; small difference where the boundaries of the CI span both sides of the MID; little or no difference where the boundaries of the CI are completely outside the MID but doesn’t cross the midline; unclear evidence of harm where the boundaries of the CI span both sides of the midline; clear evidence of harm where the boundaries of the CI fall completely within harm (Herbert 2011).

Appendices

Appendix 1. Search strategy

Appendix 1. Search strategy: The Cochrane Library

#1 MeSH descriptor back pain explode all trees
#2 MeSH descriptor pain explode all trees
#3 (back or spine or spinal) adj2 pain
#4 lumbar* or lumbo*

#5 backache* or back ache*

#6 (#1 OR #2 OR #3 OR #4 OR #5)

[Limited to Cochrane reviews]

Contributions of authors

AGC conceived the overview, provided methodological expertise and wrote the protocol.

RRNR conceived the overview, provided methodological expertise and wrote the protocol.

BMW conceived the overview, provided methodological and statistical expertise.

NEO conceived the overview, provided methodological and statistical expertise.

HL provided systematic review, methodological and clinical area expertise.

MKB provided systematic review methodological expertise.

EO provided methodological expertise.

CGM provided systematic review methodological and clinical area expertise.

ADF provided systematic review methodological and clinical area expertise.

MWvT provided systematic review methodological and clinical area expertise.

JHM is the guarantor and conceived the overview, provided systematic review and clinical area expertise.

All authors read, contributed to and approved the final version of the manuscript.

Sources of support

Internal sources

  • Brunel University London, UK

    (NEO)

  • Institute for Work & Health, Canada

    (ADF)

External sources

  • Australian Government Research Training Program, Australia

    Postgraduate Research Scholarship (MKB, EO)

  • National Health and Medical Research Council, Australia

    Research Fellowship (CGM), Program Grant (HL, CGM), Centre for Research Excellence (CGM)

  • Neuroscience Research Australia (NeuRA), Australia

    PhD Candidature Supplementary Scholarship (AGC, RRNR, MKB, EO)

  • University of New South Wales, Australia

    Research Excellence Award (MKB)

  • University of New South Wales Prince of Wales Clinical School, Australia

    Postgraduate Research Scholarship (AGC)

Declarations of interest

MKB has received support from his institution (UNSW) for conference travel that is unrelated to the present work, from the Chiropractor's Association of Australia to speak about pain rehabilitation and from the Memorial University of Newfoundland to speak about engagement with research evidence, including evidence about medicines. MKB's salary is provided by scholarships. MKB is first author on the Cochrane Review 'Paracetamol, NSAIDs or opioid analgesics for chronic low back pain: a network meta‐analysis' and will not be involved in any decisions about this review in the Overview.
CGM has received competitive grants from government agencies and industry to support his research. As an invited speaker at conferences, he has had his expenses covered and also received small gifts such as a box of chocolates or a bottle of wine. He has received honoraria for marking theses, reviewing grants and preparing talks. CGM has published multiple papers on low back pain, some of which may be referenced in the review, and is on the Editorial Board of Cochrane Back and Neck review group. Mitigation of conflict of interest: CGM will not be involved in editorial decisions on this review.
ADF is on the Editorial Board of Cochrane Back and Neck review group. ADF was co‐ordinating Editor until December 2020. Mitigation of conflict of interest: ADF will not be involved in decisions to approve or reject this review. She has published multiple papers on low back pain, some of which may be referenced in the review. The institutions where ADF works have received various grants from external organisations, including government and public institutions in Ontario, Canada, and the UK. ADF has a monetized YouTube channel and she receives revenues from AdSense.
MWvT is on the Editorial Board of Cochrane Back and Neck review group. MWvT was co‐ordinating Editor until September 2017. Mitigation of conflict of interest: MWvT will not be involved in editorial decisions on this review. MWvT has published multiple papers on low back pain, some of which may be referenced in the review. MWvT has no additional competing interest; all research funding comes from non‐ profit, governmental funding agencies, and all funding (including travel and stay expenses) were paid to the VU University.
HL has consulted for Cancer Council Australia; and has received funding from the Australian Health and Medical Research Council (grant no. APP1126767), and Center for Effective Global Action (CEGA) & Berkeley Initiative for Transparency in the Social Sciences (BITSS).
AGC, RRNR, BMW, NEO, EO and JHM have no known declarations.
This research project did not receive any specific grant from funding agencies in the public, commercial, or not‐for‐profit sectors.

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References

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