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Systematic Review to Inform a World Health Organization (WHO) Clinical Practice Guideline: Benefits and Harms of Structured and Standardized Education or Advice for Chronic Primary low back pain in Adults

Southerst, Danielle; Hincapié, Cesar A; Yu, Hainan; Verville, Leslie; Bussières, André; Gross, Douglas P; Pereira, Paulo; Mior, Silvano; Tricco, Andrea C; Cedraschi, Christine; Brunton, Ginny; Nordin, Margareta; Wong, Jessica J; Connell, Gaelan; Shearer, Heather M; DeSouza, Astrid; Muñoz Laguna, Javier; Lee, Joyce G B; To, Daphne; Lalji, Rahim; Stuber, Kent; Funabashi, Martha; Hofstetter, Léonie; Myrtos, Danny; Romanelli, Andrew; Guist, Brett; Young, James J; da Silva-Oolup, Sophia; Stupar, Maja; Wang, Dan; Murnaghan, Kent; Cancelliere, Carol
PURPOSE/OBJECTIVE:Evaluate benefits and harms of education/advice 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 education/advice compared with placebo/sham, usual care, or no intervention (including comparison interventions where the attributable effect of education/advice could be isolated). We conducted meta-analyses and graded the certainty of evidence. RESULTS:We screened 2514 citations and 86 full text RCTs and included 15 RCTs. Most outcomes were assessed 3 to 6 months post-intervention. Compared with no intervention, education/advice improved pain (10 RCTs, MD = -1.1, 95% CI -1.63 to -0.56), function (10 RCTs, SMD = -0.51, 95% CI -0.89 to -0.12), physical health-related quality of life (HRQoL) (2 RCTs, MD = 24.27, 95% CI 12.93 to 35.61), fear avoidance (5 RCTs, SMD = -1.4, 95% CI -2.51 to -0.29), depression (1 RCT; MD = 2.10, 95% CI 1.05 to 3.15), and self-efficacy (1 RCT; MD = 4.4, 95% CI 2.77 to 6.03). Education/advice conferred less benefit than sham Kinesio taping for improving fear avoidance regarding physical activity (1 RCT, MD = 5.41, 95% CI 0.28 to 10.54). Compared with usual care, education/advice improved pain (1 RCT, MD = -2.10, 95% CI -3.13 to -1.07) and function (1 RCT, MD = -7.80, 95% CI -14.28 to -1.32). There was little or no difference between education/advice and comparisons for other outcomes. For all outcomes, the certainty of evidence was very low. CONCLUSION/CONCLUSIONS:Education/advice in adults with CPLBP was associated with improvements in pain, function, HRQoL, and psychological outcomes, but with very low certainty.
PMCID:10684630
PMID: 37991651
ISSN: 1573-3688
CID: 5608592

Improving Rehabilitation Research to Optimize Care and Outcomes for People with Chronic Primary Low Back Pain: Methodological and Reporting Recommendations from a WHO Systematic Review Series

Cancelliere, Carol; Yu, Hainan; Southerst, Danielle; Connell, Gaelan; Verville, Leslie; Bussières, André; Gross, Douglas P; Pereira, Paulo; Mior, Silvano; Tricco, Andrea C; Cedraschi, Christine; Brunton, Ginny; Nordin, Margareta; Shearer, Heather M; Wong, Jessica J; Hayden, Jill A; Ogilvie, Rachel; Wang, Dan; Côté, Pierre; Hincapié, Cesar A
Chronic primary low back pain (CPLBP) is a prevalent and disabling condition that often requires rehabilitation interventions to improve function and alleviate pain. This paper aims to advance future research, including systematic reviews and randomized controlled trials (RCTs), on CPLBP management. We provide methodological and reporting recommendations derived from our conducted systematic reviews, offering practical guidance for conducting robust research on the effectiveness of rehabilitation interventions for CPLBP. Our systematic reviews contributed to the development of a WHO clinical guideline for CPLBP. Based on our experience, we have identified methodological issues and recommendations, which are compiled in a comprehensive table and discussed systematically within established frameworks for reporting and critically appraising RCTs. In conclusion, embracing the complexity of CPLBP involves recognizing its multifactorial nature and diverse contexts and planning for varying treatment responses. By embracing this complexity and emphasizing methodological rigor, research in the field can be improved, potentially leading to better care and outcomes for individuals with CPLBP.
PMCID:10684421
PMID: 37991649
ISSN: 1573-3688
CID: 5608572

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

Yu, Hainan; Wang, Dan; Verville, Leslie; Southerst, Danielle; Bussières, André; Gross, Douglas P; Pereira, Paulo; Mior, Silvano; Tricco, Andrea C; Cedraschi, Christine; Brunton, Ginny; Nordin, Margareta; Shearer, Heather M; Wong, Jessica J; Connell, Gaelan; Myrtos, Danny; da Silva-Oolup, Sophia; Young, James J; Funabashi, Martha; Romanelli, Andrew; Lee, Joyce G B; Stuber, Kent; Guist, Brett; Muñoz Laguna, Javier; Hofstetter, Léonie; Murnaghan, Kent; Hincapié, Cesar A; Cancelliere, Carol
PURPOSE/OBJECTIVE: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/CONCLUSIONS: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.
PMCID:10684627
PMID: 37991648
ISSN: 1573-3688
CID: 5608562

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

Verville, Leslie; Ogilvie, Rachel; Hincapié, Cesar A; Southerst, Danielle; Yu, Hainan; Bussières, André; Gross, Douglas P; Pereira, Paulo; Mior, Silvano; Tricco, Andrea C; Cedraschi, Christine; Brunton, Ginny; Nordin, Margareta; Connell, Gaelan; Wong, Jessica J; Shearer, Heather M; Lee, Joyce G B; Wang, Dan; Hayden, Jill A; Cancelliere, Carol
PURPOSE/OBJECTIVE:Evaluate benefits and harms of structured exercise programs 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) in electronic databases (inception to 17 May 2022). Eligible RCTs targeted structured exercise programs compared to placebo/sham, usual care, or no intervention (including comparison interventions where the attributable effect of exercise could be isolated). We extracted outcomes, appraised risk of bias, conducted meta-analyses where appropriate, and assessed certainty of evidence using GRADE. RESULTS:We screened 2503 records (after initial screening through Cochrane RCT Classifier and Cochrane Crowd) and 398 full text RCTs. Thirteen RCTs rated with overall low or unclear risk of bias were synthesized. Assessing individual exercise types (predominantly very low certainty evidence), pain reduction was associated with aerobic exercise and Pilates vs. no intervention, and motor control exercise vs. sham. Improved function was associated with mixed exercise vs. usual care, and Pilates vs. no intervention. Temporary increased minor pain was associated with mixed exercise vs. no intervention, and yoga vs. usual care. Little to no difference was found for other comparisons and outcomes. When pooling exercise types, exercise vs. no intervention probably reduces pain in adults (8 RCTs, SMD = - 0.33, 95% CI - 0.58 to - 0.08) and functional limitations in adults and older adults (8 RCTs, SMD = - 0.31, 95% CI - 0.57 to - 0.05) (moderate certainty evidence). CONCLUSIONS:With moderate certainty, structured exercise programs probably reduce pain and functional limitations in adults and older people with CPLBP.
PMCID:10684665
PMID: 37991647
ISSN: 1573-3688
CID: 5608552

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

Verville, Leslie; Hincapié, Cesar A; Southerst, Danielle; Yu, Hainan; Bussières, André; Gross, Douglas P; Pereira, Paulo; Mior, Silvano; Tricco, Andrea C; Cedraschi, Christine; Brunton, Ginny; Nordin, Margareta; Connell, Gaelan; Shearer, Heather M; Wong, Jessica J; Hofstetter, Léonie; Romanelli, Andrew; Guist, Brett; To, Daphne; Stuber, Kent; da Silva-Oolup, Sophia; Stupar, Maja; Myrtos, Danny; Lee, Joyce G B; DeSouza, Astrid; Muñoz Laguna, Javier; Murnaghan, Kent; Cancelliere, Carol
PURPOSE/OBJECTIVE: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.
PMCID:10684422
PMID: 37991646
ISSN: 1573-3688
CID: 5608532

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

Cancelliere, Carol; Verville, Leslie; Southerst, Danielle; Yu, Hainan; Hayden, Jill A; Ogilvie, Rachel; Bussières, André; Gross, Douglas P; Pereira, Paulo; Mior, Silvano; Tricco, Andrea C; Cedraschi, Christine; Brunton, Ginny; Nordin, Margareta; Wong, Jessica J; Shearer, Heather M; Connell, Gaelan; Hincapié, Cesar A
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.
PMID: 37991645
ISSN: 1573-3688
CID: 5608512

A Systematic Review of Clinical Practice Guidelines for Persons With Non-specific Low Back Pain With and Without Radiculopathy: Identification of Best Evidence for Rehabilitation to Develop the WHO's Package of Interventions for Rehabilitation

Zaina, Fabio; Côté, Pierre; Cancelliere, Carolina; Di Felice, Francesca; Donzelli, Sabrina; Rauch, Alexandra; Verville, Leslie; Negrini, Stefano; Nordin, Margareta
OBJECTIVE:To Identify evidence-based rehabilitation interventions for persons with non-specific low back pain (LBP) with and without radiculopathy and to develop recommendations from high-quality clinical practice guidelines (CPGs) to inform the World Health Organization's (WHO) Package of Interventions for Rehabilitation (PIR). DATA SOURCE/METHODS:We searched MEDLINE, EMBASE, CINAHL, PsycINFO, National Health Services Economic Evaluation Database, Health Technology Assessment Database, PEDro, the Trip Database, the Index to Chiropractic Literature and the gray literature. STUDY SELECTION/METHODS:Eligible guidelines were (1) published between 2009 and 2019 in English, French, Italian, or Swedish; (2) included adults or children with non-specific LBP with or without radiculopathy; and (3) assessed the benefits of rehabilitation interventions on functioning. Pairs of independent reviewers assessed the quality of the CPGs using AGREE II. DATA SYNTHESIS/RESULTS:We identified 4 high-quality CPGs. Recommended interventions included (1) education about recovery expectations, self-management strategies, and maintenance of usual activities; (2) multimodal approaches incorporating education, exercise, and spinal manipulation; (3) nonsteroidal anti-inflammatory drugs combined with education in the acute stage; and (4) intensive interdisciplinary rehabilitation that includes exercise and cognitive/behavioral interventions for persistent pain. We did not identify high-quality CPGs for people younger than 16 years of age. CONCLUSION/CONCLUSIONS:We developed evidence-based recommendations from high-quality CPGs to inform the WHO PIR for people with LBP with and without radiculopathy. These recommendations emphasize the potential benefits of education, exercise, manual therapy, and cognitive/behavioral interventions.
PMID: 36963709
ISSN: 1532-821x
CID: 5462952

Time for a true integrated approach to spine care [Editorial]

Munting, E; Nordin, M; Pereira, P; Donzelli, S; Noël, J-L; Côté, P
PMCID:10199397
PMID: 37215682
ISSN: 2772-5294
CID: 5543642

SPINE20 recommendations 2023: One Earth, one family, one future WITHOUT spine DISABILITY

Chhabra, Harvinder S; Tamai, Koji; Alsebayel, Hana; AlEissa, Sami; Alqahtani, Yahya; Arand, Markus; Basu, Saumyajit; Blattert, Thomas R; Bussières, André; Campello, Marco; Costanzo, Giuseppe; Côté, Pierre; Darwano, Bambang; Franke, Jörg; Garg, Bhavuk; Hasan, Rumaisah; Ito, Manabu; Kamra, Komal; Kandziora, Frank; Kassim, Nishad; Kato, So; Lahey, Donna; Mehta, Ketna; Menezes, Cristiano M; Muehlbauer, Eric J; Mullerpatan, Rajani; Pereira, Paulo; Roberts, Lisa; Ruosi, Carlo; Sullivan, William; Shetty, Ajoy P; Tucci, Carlos; Wadhwa, Sanjay; Alturkistany, Ahmed; Busari, Jamiu O; Wang, Jeffrey C; Teli, Marco G A; Rajasekaran, Shanmuganathan; Mulukutla, Raghava D; Piccirillo, Michael; Hsieh, Patrick C; Dohring, Edward J; Srivastava, Sudhir K; Larouche, Jeremie; Vlok, Adriaan; Nordin, Margareta
INTRODUCTION/UNASSIGNED:The purpose is to report on the fourth set of recommendations developed by SPINE20 to advocate for evidence-based spine care globally under the theme of "One Earth, One Family, One Future WITHOUT Spine DISABILITY". RESEARCH QUESTION/UNASSIGNED:Not applicable. MATERIAL AND METHODS/UNASSIGNED:Recommendations were developed and refined through two modified Delphi processes with international, multi-professional panels. RESULTS/UNASSIGNED:Seven recommendations were delivered to the G20 countries calling them to:-establish, prioritize and implement accessible National Spine Care Programs to improve spine care and health outcomes.-eliminate structural barriers to accessing timely rehabilitation for spinal disorders to reduce poverty.-implement cost-effective, evidence-based practice for digital transformation in spine care, to deliver self-management and prevention, evaluate practice and measure outcomes.-monitor and reduce safety lapses in primary care including missed diagnoses of serious spine pathologies and risk factors for spinal disability and chronicity.-develop, implement and evaluate standardization processes for spine care delivery systems tailored to individual and population health needs.-ensure accessible and affordable quality care to persons with spine disorders, injuries and related disabilities throughout the lifespan.-promote and facilitate healthy lifestyle choices (including physical activity, nutrition, smoking cessation) to improve spine wellness and health. DISCUSSION AND CONCLUSION/UNASSIGNED:SPINE20 proposes that focusing on the recommendations would facilitate equitable access to health systems, affordable spine care delivered by a competent healthcare workforce, and education of persons with spine disorders, which will contribute to reducing spine disability, associated poverty, and increase productivity of the G20 nations.
PMCID:10668083
PMID: 38020998
ISSN: 2772-5294
CID: 5617122

SPINE20 recommendations 2022: spine care-working together to recover stronger

Darwono, Bambang; Tamai, Koji; Côté, Pierre; Aleissa, Sami; Rahim, Agus Hadian; Pereira, Paulo; Alsobayel, Hana; Chhabra, Harvinder S; Costanzo, Giuseppe; Ito, Manabu; Kandziora, Frank; Lahey, Donna; Menezes, Cristiano M; Bajammal, Sohail; Sullivan, William J; Vajkoczy, Peter; Ahmad, Alaa; Arand, Markus; Asmiragani, Saiful; Blattert, Thomas R; Busari, Jamiu; Dohring, Edward J; Misaggi, Bernardo; Muehlbauer, Eric J; Mulukutla, Raghava D; Munting, Everard; Piccirillo, Michael; Ruosi, Carlo; Alturkistany, Ahmed; Campello, Marco; Hsieh, Patrick C; Teli, Marco G A; Wang, Jeffrey C; Nordin, Margareta
PURPOSE/OBJECTIVE:Globally, spine disorders are the leading cause of disability, affecting more than half a billion individuals. However, less than 50% of G20 countries specifically identify spine health within their public policy priorities. Therefore, it is crucial to raise awareness among policy makers of the disabling effect of spine disorders and their impact on the economic welfare of G20 nations. In 2019, SPINE20 was established as the leading advocacy group to bring global attention to spine disorders. METHODS:Recommendations were developed through two Delphi methods with international and multi-professional panels. RESULTS:In 2022, seven recommendations were delivered to the leaders of G20 countries, urging them to: Develop action plans to provide universal access to evidence-based spine care that incorporates the needs of minorities and vulnerable populations. Invest in the development of sustainable human resource capacity, through multisectoral and inter-professional competency-based education and training to promote evidence-based approaches to spine care, and to build an appropriate healthcare working environment that optimizes the delivery of safe health services. Develop policies using the best available evidence to properly manage spine disorders and to prolong functional healthy life expectancy in the era of an aging population. Create a competent workforce and improve the healthcare infrastructure/facilities including equipment to provide evidence-based inter-professional rehabilitation services to patients with spinal cord injury throughout their continuum of care. Build collaborative and innovative translational research capacity within national, regional, and global healthcare systems for state-of-the-art and cost-effective spine care across the healthcare continuum ensuring equality, diversity, and inclusion of all stakeholders. Develop international consensus statements on patient outcomes and how they can be used to define and develop pathways for value-based care. Recognize that intervening on determinants of health including physical activity, nutrition, physical and psychosocial workplace environment, and smoking-free lifestyle can reduce the burden of spine disabilities and improve the health status and wellness of the population. At the third SPINE20 summit 2022 which took place in Bali, Indonesia, in August 2022, 17 associations endorsed its recommendations. CONCLUSION/CONCLUSIONS:SPINE20 advocacy efforts focus on developing public policy recommendations to improve the health, welfare, and wellness of all who suffer from spinal pain and disability. We propose that focusing on facilitating access to systems that prioritize value-based care delivered by a competent healthcare workforce will reduce disability and improve the productivity of the G20 nations.
PMID: 36326928
ISSN: 1432-0932
CID: 5358722