Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain
NCT ID: NCT03581123
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2018-11-01
2024-06-12
Brief Summary
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Detailed Description
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The US faces an unprecedented pain management crisis. LBP is the most common chronic pain condition in adults and one of the leading causes of disability worldwide. Guidelines have recommended non-drug treatments like spinal manipulation and behavioral and selfcare approaches for LBP for nearly a decade, yet uptake and adherence has been poor. Little is known about the role of these treatments in the secondary prevention of chronic LBP, especially for patients at risk of developing severe low back pain. Due to high societal costs, and side effects of commonly used drug treatments, including opioids, there is a critical need for research on how well non-drug treatments work for preventing serious chronic LBP.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Supported-Self management (SSM)
Supported-Self management
Supported-Self Management (SSM)
Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
Spinal Manipulation Therapy (SMT)
Spinal Manipulation Therapy
Spinal Manipulation Therapy (SMT)
SMT will address the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
SMT + SSM
Spinal Manipulation Therapy + Supported Self-Management
SMT + SSM
Combination Treatment
Standard Medical Care (SMC)
Standard Medical Care
Standard Medical Care (SMC)
Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
Interventions
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Supported-Self Management (SSM)
Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
Spinal Manipulation Therapy (SMT)
SMT will address the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.
SMT + SSM
Combination Treatment
Standard Medical Care (SMC)
Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
Eligibility Criteria
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Inclusion Criteria
* Acute or sub-acute low back pain
* Average low back pain severity ≥3 on the 0-10 numerical rating scale over 7 days
* Medium or high risk for persistent disabling back pain according to the STarT Back screening tool
* Ability to read and write fluently in English
Exclusion Criteria
* Contraindications to study treatments (e.g,. surgical fusion of lumbar spine)
* Active management of current episode of low back pain by another healthcare provider
* Serious co-morbid health condition that either requires medical attention or has a risk for general health decline over the next year
* Pregnancy, current or planned during study period and nursing mothers
* Inability or unwillingness to give written informed consent
18 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
University of Washington
OTHER
University of North Texas Health Science Center
OTHER
Oregon Health and Science University
OTHER
Duke University
OTHER
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Gert Bronfort, PhD, DC
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Bronfort G, Delitto A, Schneider M, Heagerty PJ, Chou R, Connett J, Evans R, George S, Glick RM, Greco C, Hanson L, Keefe F, Leininger B, Licciardone J, McFarland C, Meier E, Schulz C, Turk D. Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol. BMC Musculoskelet Disord. 2023 May 25;24(1):415. doi: 10.1186/s12891-023-06549-w.
Bronfort G, Delitto A, Schneider M, Heagerty P, Chou R, Connett J, Evans R, George S, Glick R, Greco C, Hanson L, Keefe F, Leininger B, Licciardone J, McFarland C, Meier E, Schulz C, Turk D. Effectiveness of Spinal Manipulation and Biopsychosocial Self-Management compared to Medical Care for Low Back Pain: A Randomized Trial Study Protocol. Res Sq [Preprint]. 2023 May 3:rs.3.rs-2865633. doi: 10.21203/rs.3.rs-2865633/v1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CSH-2018-26524
Identifier Type: -
Identifier Source: org_study_id
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