Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol

BMC Musculoskeletal Disorders

Study Protocol

Dennis Turk¹  John Licciardone²  Gert Bronfort³  Roni Evans³  Brent Leininger³  Craig Schulz³  Linda Hanson³  Anthony Delitto⁴  Christine McFarland⁵  Michael Schneider⁵  Francis Keefe⁶  Steven George⁷  Carol Greco⁸  Ronald M. Glick⁹  Roger Chou^1,10  Patrick J. Heagerty^1,11  Eric Meier^1,12  John Connett^1,13 

[1] Department of Anesthesiology & Pain Medicine, University of Washington, Box 358045, 98195, Seattle, WA, USA;Health Science Center, University of North Texas, 3500 Camp Bowie Blvd, 76107, Fort Worth, TX, USA;Integrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Mayo Memorial Building C504, 420 Delaware Street, 55414, Minneapolis, MN, USA;School of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, 4029 Forbes Tower, 15260, Pittsburgh, PA, USA;School of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, 100 Technology Drive, Suite 500, 15219, Pittsburgh, PA, USA;School of Medicine, Department of Medicine, Duke University, 2200 W Main St., Suite 340, 27705, Durham, NC, USA;School of Medicine, Department of Orthopaedic Surgery, Duke University, 8020 North Pavilion, 27705, Durham, NC, USA;School of Medicine, Department of Psychiatry, University of Pittsburgh, 580 S. Aiken Avenue, Suite 310, 15232, Pittsburgh, PA, USA;School of Medicine, Departments of Psychiatry and Physical Medicine & Rehabilitation, University of Pittsburgh, 580 S. Aiken Avenue, Suite 310, 15232, Pittsburgh, PA, USA;School of Medicine, Division of General Internal Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road L475, 97239-3098, Portland, OR, USA;School of Public Health, Department of Biostatistics, University of Washington, Box 357232, 1959 NE Pacific Street, 98195, Seattle, WA, USA;School of Public Health, Department of Biostatistics, University of Washington, Box 359461, 4333 Brooklyn Avenue NE, 98195, Seattle, WA, USA;School of Public Health, Division of Biostatistics, University of Minnesota, 717 Delaware Street SE, 2nd Floor, 5455, Minneapolis, MN, USA;

关键词: Low back pain;    Spinal manipulation;    Medical care;    Self-management;   

DOI  :  10.1186/s12891-023-06549-w

 received in 2023-04-26, accepted in 2023-05-18,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundChronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis.MethodsWe have designed a phase 3 randomized trial with a 2 × 2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10–12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients’ intervention assignment.DiscussionBy targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem.Trial registrationClinicalTrials.gov Identifier: NCT03581123.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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