Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain

NCT03581123 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CSH-2018-26524
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.

Conditions

Acute Pain; Low Back Pain, Mechanical

Keywords

acute/subacute low back pain; randomized clinical trial; self-management; behavioral modification; spinal manipulation therapy; standard medical care; secondary prevention

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible). Missing weekly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline pain intensity.

  Average over weeks 1-52

• Disability

  Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities. Score ranges from 0 to 24 with higher values indicating more disability. Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline RMDQ.

  Average over months 1-12

• Low Back Pain (LBP) That is Impactful

  Measured by the LBP impact scale, which includes measures of pain intensity, pain interference, and physical function from the PROMIS-29 Profile v2.0. The scale ranges from 8 (least impact) to 50 (greatest impact). Missing monthly outcomes were multiply imputed. Means were estimated using marginal standardization with adjustment for site, time period, risk of chronicity, and baseline LBP impact score.

  Average over months 10 -12

Secondary Outcomes (30)

• Recovery From Acute/Sub-acute Low Back Pain

  6 months

• Low Back Pain Frequency - Percent of Days Over 12 Months

  Weeks 1-52

• Number of Participants Who Received Care For Low Back Pain

  Months 1-12

• Medication Use - Percent of Months 4-12

  Months 4-12

• Bothered by Low Back Pain at Work - Percent of Months

  Months 1-12

Other Outcomes (4)

• Self-efficacy

  Baseline, 2, 6, 12 months

• Catastrophizing

  Baseline, 2, 6, 12 months

• Kinesiophobia

  Baseline, 2, 6, 12 months

Study Arms (4)

Supported-Self management (SSM)

EXPERIMENTAL

Supported-Self management

Behavioral: Supported-Self Management (SSM)

Spinal Manipulation Therapy (SMT)

EXPERIMENTAL

Spinal Manipulation Therapy

Other: Spinal Manipulation Therapy (SMT)

SMT + SSM

EXPERIMENTAL

Spinal Manipulation Therapy + Supported Self-Management

Combination Product: SMT + SSM

Standard Medical Care (SMC)

ACTIVE COMPARATOR

Standard Medical Care

Drug: Standard Medical Care (SMC)

Interventions

Supported-Self Management (SSM) BEHAVIORAL

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.

Supported-Self management (SSM)

Spinal Manipulation Therapy (SMT) OTHER

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.

Spinal Manipulation Therapy (SMT)

SMT + SSM COMBINATION_PRODUCT

Combination Treatment

SMT + SSM

Standard Medical Care (SMC) DRUG

Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.

Standard Medical Care (SMC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• 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

You may not qualify if:

• Non-mechanical causes of low back pain
• 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

Sponsors & Collaborators

• University of Minnesota: lead
• University of Pittsburgh: collaborator
• University of Washington: collaborator
• University of North Texas Health Science Center: collaborator
• Oregon Health and Science University: collaborator
• Duke University: collaborator

Study Sites (3)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• Bronfort G, Meier EN, Leininger B, Schneider M, Evans R, Greco C, Hanson L, McFarland C, Chou R, Connett J, Delitto A, George SZ, Glick RM, Keefe F, Licciardone J, Schulz C, Turk D, Heagerty PJ. Spinal Manipulation and Clinician-Supported Biopsychosocial Self-Management for Acute Back Pain: The PACBACK Randomized Clinical Trial. JAMA. 2025 Dec 29:e2521990. doi: 10.1001/jama.2025.21990. Online ahead of print.

  PMID: 41460638 DERIVED

• 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.

  PMID: 37231386 DERIVED

• 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.

  PMID: 37205428 DERIVED

MeSH Terms

Conditions

Acute Pain; Low Back Pain

Interventions

specific substance maruyama

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Results Point of Contact

• Title: Eric Meier, Study Biostatistician
• Organization: University of Washington

emeier11@uw.edu

206-450-0020

Study Officials

• Gert Bronfort, PhD, DC

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 factorial design

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: July 10, 2018
• Study Start: November 1, 2018
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Locations

US (3)