Systematic Review Procedures for the World Health Organization (WHO) Evidence Syntheses on Benefits and Harms of Structured and Standardized Education/Advice, Structured Exercise Programs, Transcutaneous Electrical Nerve Stimulation (TENS), and Needling Therapies for the Management of Chronic Low Back Pain in Adults.

As commissioned by the WHO, we updated and expanded the scope of four systematic reviews to inform its (in development) clinical practice guideline for the management of CPLBP in adults, including older adults. Methodological details and results of each review are described in the respective articles in this series. In the last article of this series, we discuss methodological considerations, clinical implications and recommendations for future research.

Systematic Review to Inform a World Health Organization (WHO) Clinical Practice Guideline: Benefits and Harms of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Primary Low Back Pain in Adults.

PURPOSE: To evaluate benefits and harms of transcutaneous electrical nerve stimulation (TENS) for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline. METHODS: We searched for randomized controlled trials (RCTs) from various electronic databases from July 1, 2007 to March 9, 2022. Eligible RCTs targeted TENS compared to placebo/sham, usual care, no intervention, or interventions with isolated TENS effects (i.e., combined TENS with treatment B versus treatment B alone) in adults with CPLBP. We extracted outcomes requested by the WHO Guideline Development Group, appraised the risk of bias, conducted meta-analyses where appropriate, and graded the certainty of evidence using GRADE. RESULTS: Seventeen RCTs (adults, n = 1027; adults ≥ 60 years, n = 28) out of 2010 records and 89 full text RCTs screened were included. The evidence suggested that TENS resulted in a marginal reduction in pain compared to sham (9 RCTs) in the immediate term (2 weeks) (mean difference (MD) = -0.90, 95% confidence interval -1.54 to -0.26), and a reduction in pain catastrophizing in the short term (3 months) with TENS versus no intervention or interventions with TENS specific effects (1 RCT) (MD = -11.20, 95% CI -17.88 to -3.52). For other outcomes, little or no difference was found between TENS and the comparison interventions. The certainty of the evidence for all outcomes was very low. CONCLUSIONS: Based on very low certainty evidence, TENS resulted in brief and marginal reductions in pain (not deemed clinically important) and a short-term reduction in pain catastrophizing in adults with CPLBP, while little to no differences were found for other outcomes.

Systematic Review to Inform a World Health Organization (WHO) Clinical Practice Guideline: Benefits and Harms of Needling Therapies for Chronic Primary Low Back Pain in Adults.

PURPOSE: Evaluate benefits and harms of needling therapies (NT) for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline. METHODS: Electronic databases were searched for randomized controlled trials (RCTs) assessing NT compared with placebo/sham, usual care, or no intervention (comparing interventions where the attributable effect could be isolated). We conducted meta-analyses where indicated and graded the certainty of evidence. RESULTS: We screened 1831 citations and 109 full text RCTs, yeilding 37 RCTs. The certainty of evidence was low or very low across all included outcomes. There was little or no difference between NT and comparisons across most outcomes; there may be some benefits for certain outcomes. Compared with sham, NT improved health-related quality of life (HRQoL) (physical) (2 RCTs; SMD = 0.20, 95%CI 0.07; 0.32) at 6 months. Compared with no intervention, NT reduced pain at 2 weeks (21 RCTs; MD = - 1.21, 95%CI - 1.50; - 0.92) and 3 months (9 RCTs; MD = - 1.56, 95%CI - 2.80; - 0.95); and reduced functional limitations at 2 weeks (19 RCTs; SMD = - 1.39, 95%CI - 2.00; - 0.77) and 3 months (8 RCTs; SMD = - 0.57, 95%CI - 0.92; - 0.22). In older adults, NT reduced functional limitations at 2 weeks (SMD = - 1.10, 95%CI - 1.71; - 0.48) and 3 months (SMD = - 1.04, 95%CI - 1.66; - 0.43). Compared with usual care, NT reduced pain (MD = - 1.35, 95%CI - 1.86; - 0.84) and functional limitations (MD = - 2.55, 95%CI - 3.70; - 1.40) at 3 months. CONCLUSION: Based on low to very low certainty evidence, adults with CPLBP experienced some benefits in pain, functioning, or HRQoL with NT; however, evidence showed little to no differences for other outcomes.

Conservative Management of Cervical Radiculopathy: A Systematic Review.

OBJECTIVE: The purpose of this systematic review was to assess the effectiveness and safety of conservative interventions compared with other interventions, placebo/sham interventions, or no intervention on disability, pain, function, quality of life, and psychological impact in adults with cervical radiculopathy (CR). METHODS: We searched MEDLINE, CENTRAL, CINAHL, Embase, and PsycINFO from inception to June 15, 2022 to identify studies that were randomized controlled trials, had at least one conservative treatment arm, and diagnosed participants with CR through confirmatory clinical examination and/or diagnostic tests. Studies were appraised using the Cochrane Risk of Bias 2 tool and the quality of the evidence was rated using the Grades of Recommendations, Assessment, Development, and Evaluation approach. RESULTS: Of the 2561 records identified, 59 trials met our inclusion criteria (n = 4108 participants). Due to clinical and statistical heterogeneity, the findings were synthesized narratively. There is very-low certainty evidence supporting the use of acupuncture, prednisolone, cervical manipulation, and low-level laser therapy for pain and disability in the immediate to short-term, and thoracic manipulation and low-level laser therapy for improvements in cervical range of motion in the immediate term. There is low to very-low certainty evidence for multimodal interventions, providing inconclusive evidence for pain, disability, and range of motion. There is inconclusive evidence for pain reduction after conservative management compared with surgery, rated as very-low certainty. DISCUSSION: There is a lack of high-quality evidence, limiting our ability to make any meaningful conclusions. As the number of people with CR is expected to increase, there is an urgent need for future research to help address these gaps.

Exploring clinician perceptions of a care pathway for the management of shoulder pain: a qualitative study.

BACKGROUND: Clinical care pathways may be useful tools to improve the quality of healthcare by facilitating the translation of evidence into practice. Our study is situated within a larger project, whereby end-users co-developed a care pathway for the management of shoulder pain. In this study, we explored end-user perceptions of the usefulness and practicality of implementing a care pathway to manage shoulder pain. We also solicited feedback for the pathway's improvement. METHODS: We conducted a qualitative study using a transcendental phenomenological approach seen through a constructivist lens. Clinicians recorded themselves interacting with the care pathway while working through a clinical case. Clinicians described their thoughts and movements aloud as they completed the activity. Second, we conducted individual semi-structured interviews to discuss the usefulness and practicality of pathway implementation. Interview transcripts were coded independently by reviewers. Transcript codes and associated quotes were grouped into themes. Themes were sequenced and linked creating a 'web' of thematic connections. Summary statements were developed to synthesize the overall essence of the phenomena. RESULTS: Nine clinicians participated. Participants included eight chiropractors and one medical physician. We found that clinicians believed the care pathway could be useful at various levels, including education (students, interns), for early career clinicians, for engaging patients, facilitating interprofessional communication, and as a reminder of information for certain, less familiar conditions. When discussing the practicality of implementing the care pathway into practice settings, clinicians expressed that agreement with the care pathway and its recommendations may influence its acceptability among clinicians. Additionally, integrating recommendations into practice may be a skill requirement included into clinical training. Clinicians described the importance of opinion leaders in the acceptability of new evidence. Various difficulties with the replicability of interventions into clinical care was also discussed. In general, clinicians suggested the layout of the care pathway was manageable, and there was sufficient information for clinical decision-making. Clinicians also made several recommendations for improvement. CONCLUSIONS: End-user involvement and collaboration provides tangible instruction to improve care pathways themselves, their implementation strategies and helps to support and strengthen future research for overcoming individual, systemic and contextual barriers.

Non-operative treatment for lumbar spinal stenosis with neurogenic claudication: an updated systematic review.

OBJECTIVES: Neurogenic claudication due to lumbar spinal stenosis (LSS) is a growing health problem in older adults. We updated our previous Cochrane review (2013) to determine the effectiveness of non-operative treatment of LSS with neurogenic claudication. DESIGN: A systematic review. DATA SOURCES: CENTRAL, MEDLINE, EMBASE, CINAHL and Index to Chiropractic Literature databases were searched and updated up to 22 July 2020. ELIGIBILITY CRITERIA: We only included randomised controlled trials published in English where at least one arm provided data on non-operative treatment and included participants diagnosed with neurogenic claudication with imaging confirmed LSS. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data and assessed risk of bias using the Cochrane Risk of Bias Tool 1. Grading of Recommendations Assessment, Development and Evaluation was used for evidence synthesis. RESULTS: Of 15 200 citations screened, 156 were assessed and 23 new trials were identified. There is moderate-quality evidence from three trials that: Manual therapy and exercise provides superior and clinically important short-term improvement in symptoms and function compared with medical care or community-based group exercise; manual therapy, education and exercise delivered using a cognitive-behavioural approach demonstrates superior and clinically important improvements in walking distance in the immediate to long term compared with self-directed home exercises and glucocorticoid plus lidocaine injection is more effective than lidocaine alone in improving statistical, but not clinically important improvements in pain and function in the short term. The remaining 20 new trials demonstrated low-quality or very low-quality evidence for all comparisons and outcomes, like the findings of our original review. CONCLUSIONS: There is moderate-quality evidence that a multimodal approach which includes manual therapy and exercise, with or without education, is an effective treatment and that epidural steroids are not effective for the management of LSS with neurogenic claudication. All other non-operative interventions provided insufficient quality evidence to make conclusions on their effectiveness. PROSPERO REGISTRATION NUMBER: CRD42020191860.

Brief action planning to facilitate the management of acute low back pain with radiculopathy and yellow flags: a case report.

INTRODUCTION: Brief action planning (BAP) is a collaborative tool to support patients' self-management goal setting and action planning. BAP facilitates patient self-reflection, and provides opportunity to establish goals of their own priority. CASE PRESENTATION: A 55 year-old female with recentonset low back pain with L5 nerve root distribution, described severe pain in the low back and sharp pain and tingle-sensations down to her right foot. Pain worsened with sitting, coughing, and bending. She was diagnosed with lumbar and other intervertebral disc disorder with radiculopathy (ICD 10: M51.1). TREATMENT: Initial treatment included reassurance, education, promotion of movement, and manual therapies. Symptoms worsened at the eighth visit (five weeks) where she also demonstrated pain-catastrophizing behaviours and an over-reliance on passive treatment strategies (i.e., psychosocial factors or yellow flags). BAP was introduced into her treatment plan to set achievable goals for her care. OUTCOME: Decreased pain and disability were reported after incorporating BAP into care. Reduced pain-catastrophizing and reduced over-dependence on passive strategies were also demonstrated. Clinical gains were sustained at the 10-week follow-up assessment. KEY CLINICAL MESSAGE: We describe the utilization of brief action planning as a technique for improving adherence to evidence-based clinical practice guideline recommendations in a patient with acute low back pain and radiculopathy, and late-onset psychosocial factors.

INTRODUCTION: L'outil collaboratif Brief action planning (BAP) sert à aider les patients à se fixer des objectifs et à prévoir leurs interventions. Il favorise l'autoréflexion du patient tout en lui permettant d'établir des objectifs selon l'ordre de priorité qu'il établit lui-même. PRÉSENTATION DU CAS: Une femme de 55 ans souffrant d'une lombalgie d'apparition récente, accompagnée d'une douleur selon la distribution de la racine nerveuse L5, se plaignait d'une douleur lombaire intense, d'une douleur aiguë et de picotements jusqu'au pied droit. La douleur s'aggravait en s'assoyant, en toussant et en se penchant. On lui a diagnostiqué un trouble du disque intervertébral lombaire avec radiculopathie (CIM 10: M51.1). TRAITEMENT: On a commencé par réconforter la patiente, l'informer, favoriser le mouvement et à administrer des thérapies manuelles. Ses symptômes se sont aggravés à partir de la huitième consultation (au bout de cinq semaines). Elle a commencé à dramatiser sa douleur et à trop compter sur des stratégies de traitement passives (c'est-à-dire intervention sur les facteurs de risque psychosociaux (qu'on appelle aussi « drapeaux jaunes ¼)). On a utilisé le BAP pour qu'elle puisse se fixer des objectifs thérapeutiques réalisables. RÉSULTAT: On a observé une diminution de la douleur et de l'incapacité après le début de l'utilisation du BAP. On a aussi noté une réduction de la dramatisation de la douleur et de la dépendance excessive envers les stratégies passives. La patiente a continué à faire des gains jusqu'à l'examen de suivi, à la 10e semaine. MESSAGE CLINIQUE CLÉ: Nous définissons l'outil BAP comme une technique servant à favoriser l'observance des directives et des recommandations fondées sur des preuves chez un patient souffrant de lombalgie aiguë accompagnée d'une radiculopathie et de facteurs psychosociaux tardifs.

Assessment of Studies Evaluating Spinal Manipulative Therapy and Infectious Disease and Immune System Outcomes: A Systematic Review.

Importance: Claims that spinal manipulative therapy (SMT) can improve immune function have increased substantially during the COVID-19 pandemic and may have contributed to the rapid spread of both accurate and inaccurate information (referred to as an infodemic by the World Health Organization). Objective: To identify, appraise, and synthesize the scientific literature on the efficacy and effectiveness of SMT in preventing the development of infectious disease or improving disease-specific outcomes in patients with infectious disease and to examine the association between SMT and selected immunological, endocrine, and other physiological biomarkers. Evidence Review: A literature search of MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Index to Chiropractic Literature, the Cochrane Central Register of Controlled Trials, and Embase was conducted from inception to April 15, 2020. Randomized clinical trials and cohort studies were included. Eligible studies were critically appraised, and evidence with high and acceptable quality was synthesized using the Synthesis Without Meta-Analysis guideline. Findings: A total of 2593 records were retrieved; after exclusions, 50 full-text articles were screened, and 16 articles reporting the findings of 13 studies comprising 795 participants were critically appraised. The literature search found no clinical studies that investigated the efficacy or effectiveness of SMT in preventing the development of infectious disease or improving disease-specific outcomes among patients with infectious disease. Eight articles reporting the results of 6 high- and acceptable-quality RCTs comprising 529 participants investigated the effect of SMT on biomarkers. Spinal manipulative therapy was not associated with changes in lymphocyte levels or physiological markers among patients with low back pain or participants who were asymptomatic compared with sham manipulation, a lecture series, and venipuncture control groups. Spinal manipulative therapy was associated with short-term changes in selected immunological biomarkers among asymptomatic participants compared with sham manipulation, a lecture series, and venipuncture control groups. Conclusions and Relevance: In this systematic review of 13 studies, no clinical evidence was found to support or refute claims that SMT was efficacious or effective in changing immune system outcomes. Although there were limited preliminary data from basic scientific studies suggesting that SMT may be associated with short-term changes in immunological and endocrine biomarkers, the clinical relevance of these findings is unknown. Given the lack of evidence that SMT is associated with the prevention of infectious diseases or improvements in immune function, further studies should be completed before claims of efficacy or effectiveness are made.

Characteristics of adolescent athletes seeking early versus late care for sport-related concussion.

OBJECTIVES: 1) To determine which characteristics of adolescent athletes with SRC are associated with 'early' versus 'late' presentation for multimodal treatment; 2) to build a propensity score to investigate the effects of treatment timing during the management of SRCs. METHODS: Associations between early (0-7 days) versus late (8-28 days) presentation for treatment and pre-specified sociodemographic, pre-injury and injury characteristics were investigated in a historical cohort study of 2949 multi-sport athletes across Canada aged 12-18 years diagnosed with a SRC in community-based healthcare clinics. RESULTS: Early presentation was associated with being male, completing a pre-injury baseline assessment, and responding 'yes' or 'no' to having a diagnosed learning disability. Older athletes who reported previous SRCs were less likely to present early. The propensity score demonstrated an area under the curve of 0.71 (95% CI, 0.69 to 0.73). CONCLUSIONS: Male athletes with a completed baseline assessment were more likely to seek early treatment following a SRC, and older athletes who reported a greater number of previous SRCs were less likely to present early. External validation of the propensity score is needed before examining the impact of treatment timing on adolescent athlete recovery outcomes.

OBJECTIFS: 1) Trouver les caractéristiques des athlètes adolescents ayant subi une CCLS qui sont associées à la consultation précoce et à une consultation tardive; 2) établir un score de propension pour étudier les effets du moment du traitement pendant la prise en charge de la CCLS. MÉTHODOLOGIE: Les liens entre la consultation précoce (de 0 à 7 jours) et la consultation tardive (de 8 à 28 jours) et les caractéristiques sociodémographiques, les caractéristiques avant la blessure et les caractéristiques après des blessure prédéterminées ont été examinés au cours d'une étude de cohorte historique menée auprès de 2 949 adolescents multisports répartis dans toutes les régions du Canada, âgés de 12 à 18 ans, chez lesquels une CCLS avait été diagnostiquée dans des cliniques de santé communautaires. RÉSULTATS: La consultation précoce a été associée au sexe masculin, à une évaluation de départ avant la blessure et à la présence ou à l'absence d'un trouble de l'apprentissage. Les athlètes plus âgés ayant signalé des CCLS antérieures étaient moins susceptibles de consulter précocement. Le score de propension a démontré une aire sous la courbe de 0,71 (IC à 95 %: 0,69 à 0,73). CONCLUSIONS: Les athlètes masculins ayant subi une évaluation de départ étaient plus susceptibles de consulter précocement après une CCRS alors que les athlètes âgés ayant déclaré un plus grand nombre de CCRS antérieures étaient moins susceptibles de consulter précocement. Une validation externe du score de propension serait nécessaire avant d'examiner l'effet du moment de la consultation sur les résultats de récupération chez les athlètes adolescents.

The clinical utility of routine spinal radiographs by chiropractors: a rapid review of the literature.

INTRODUCTION: When indicated by signs or symptoms of potentially serious underlying pathology (red flags), chiropractors can use radiographs to inform their diagnosis. In the absence of red flags, the clinical utility of routine or repeat radiographs to assess the structure and function of the spine is controversial. OBJECTIVES: To determine the diagnostic and therapeutic utility of routine or repeat radiographs (in the absence of red flags) of the cervical, thoracic or lumbar spine for the functional or structural evaluation of the spine. Investigate whether functional or structural findings on repeat radiographs are valid markers of clinically meaningful outcomes. The research objectives required that we determine the validity, diagnostic accuracy and reliability of radiographs for the structural and functional evaluation of the spine. EVIDENCE REVIEW: We searched MEDLINE, CINAHL, and Index to Chiropractic Literature from inception to November 25, 2019. We used rapid review methodology recommended by the World Health Organization. Eligible studies (cross-sectional, case-control, cohort, randomized controlled trials, diagnostic and reliability) were critically appraised. Studies of acceptable quality were included in our synthesis. The lead author extracted data and a second reviewer independently validated the data extraction. We conducted a qualitative synthesis of the evidence. FINDINGS: We identified 959 citations, screened 176 full text articles and critically appraised 23. No relevant studies assessed the clinical utility of routine or repeat radiographs (in the absence of red flags) of the cervical, thoracic or lumbar spine for the functional or structural evaluation of the spine. No studies investigated whether functional or structural findings on repeat radiographs are valid markers of clinically meaningful outcomes. Nine low risk of bias studies investigated the validity (n = 2) and reliability (n = 8) of routine or repeat radiographs. These studies provide no evidence of clinical utility. CONCLUSION: We found no evidence that the use of routine or repeat radiographs to assess the function or structure of the spine, in the absence of red flags, improves clinical outcomes and benefits patients. Given the inherent risks of ionizing radiation, we recommend that chiropractors do not use radiographs for the routine and repeat evaluation of the structure and function of the spine.

Postsurgical rehabilitation for adults with low back pain with or without radiculopathy who were treated surgically: protocol for a mixed studies systematic review.

INTRODUCTION: Surgical rates for low back pain (LBP) have been increasing in Europe, North America and Asia. Many patients treated surgically will require postsurgical rehabilitation. Little is known about the effectiveness of postsurgical rehabilitation interventions on health outcomes or about patients' experiences with these interventions. OBJECTIVES: To conduct a mixed studies systematic review of quantitative and qualitative studies regarding: (1) the effectiveness and safety of postsurgical rehabilitation interventions for adults with LBP treated surgically and (2) the experiences of patients, healthcare providers, caregivers or others involved with the rehabilitation. METHODS AND ANALYSIS: We will search MEDLINE, Embase, PsycINFO, CINAHL, the Index to Chiropractic Literature, the Cochrane Controlled Register of Trials and the Rehabilitation & Sports Medicine Source for peer-reviewed empirical studies published from inception in any language. Studies using quantitative, qualitative and mixed methodologies will be included. We will also search reference lists of all eligible articles. Data extraction will include type of presurgical pathology, indication for surgery, surgical procedure, how the intervention was delivered and by whom, context and setting. We will conduct a quality assessment of each study and consider study quality in our evidence synthesis. We will use a sequential approach at the review level to synthesise and integrate data. First, we will synthesise the quantitative and qualitative studies independently, conducting a meta-analysis of the quantitative studies if appropriate and thematic synthesis of the qualitative studies. Then, we will integrate the quantitative and qualitative evidence by juxtaposing the findings in a matrix. ETHICS AND DISSEMINATION: Ethical approval is not required for this knowledge synthesis. Findings will be disseminated through knowledge translation activities including: (1) presentations at national and international conferences and scientific meetings; (2) presentations to local and international stakeholders; (3) publications in peer-reviewed journals and (4) posts on organisational websites. PROSPERO REGISTRATION NUMBER: CRD42019134607.

The safety of spinal manipulative therapy in children under 10 years: a rapid review.

INTRODUCTION: The safety of spinal manipulative therapy (SMT) in children is controversial. We were mandated by the College of Chiropractors of British Columbia to review the evidence on this issue. OBJECTIVES: We conducted a rapid review of the safety of SMT in children (< 10 years). We aimed to: 1) describe adverse events; 2) report the incidence of adverse events; and 3) determine whether SMT increases the risk of adverse events compared to other interventions. EVIDENCE REVIEW: We searched MEDLINE, CINAHL, and Index to Chiropractic Literature from January 1, 1990 to August 1, 2019. We used rapid review methodology recommended by the World Health Organization. Eligible studies (case reports/series, cohort studies and randomized controlled trials) were critically appraised. Studies of high and acceptable methodological quality were included. The lead author extracted data. Data extraction was independently validated by a second reviewer. We conducted a qualitative synthesis of the evidence. FINDINGS: Most adverse events are mild (e.g., increased crying, soreness). One case report describes a severe adverse event (rib fracture in a 21-day-old) and another an indirect harm in a 4-month-old. The incidence of mild adverse events ranges from 0.3% (95% CI: 0.06, 1.82) to 22.22% (95% CI: 6.32, 54.74). Whether SMT increases the risk of adverse events in children is unknown. CONCLUSION: The risk of moderate and severe adverse events is unknown in children treated with SMT. It is unclear whether SMT increases the risk of adverse events in children < 10 years.