Veterans Response to Dosage in Chiropractic Therapy

NCT04087291 | Completed DMC

• 2 other identifiers: 18-34UH3AT009761
• Study Type: interventional
• Target: 766
• Locations: 1 country
• Sites: 4

Brief Summary

This study evaluates how Veterans with chronic low back pain (cLBP) respond to varying doses of chiropractic therapy and how health services utilization are impacted as a result. There are 2 phases in this study. In Phase 1, half of participants will receive a low dose (1-5 visits) of chiropractic care for 10 weeks, while the other half will receive a higher dose (8-12 visits) for 10 weeks. At the end of Phase 1, participants in each group will be randomized again to receive either chronic chiropractic pain management (CCPM) (1 scheduled chiropractic visit per month x 10 months) or no CCPM for 10 months.

Conditions

Low Back Pain; Patient Acceptance of Health Care; Veterans Health

Keywords

chronic; pain management; manipulation, chiropractic

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Low Back Pain Disability at several time points - Roland Morris Disability Questionnaire (RMDQ)

  A one-page, 24-item questionnaire related to low back pain disability. The RMDQ can discriminate between different forms of treatment for back pain, and is sensitive to clinical change.

  At Baseline and Weeks 5, 10, 26, 40, and 52

Secondary Outcomes (1)

• Healthcare Services Utilization

  52 weeks

Study Arms (4)

Phase 1: Low Dose (1-5 visits)

ACTIVE COMPARATOR

Veterans with cLBP who will be randomly allocated to undergo a course of a low dose (1-5 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1).

Other: Chiropractic Care

Phase 1: Higher Dose (8-12 visits)

ACTIVE COMPARATOR

Veterans with cLBP who will be randomly allocated to undergo a course of a higher dose (8-12 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1).

Other: Chiropractic Care

Phase 2: CCPM

ACTIVE COMPARATOR

After Phase 1, Veterans with cLBP who will be randomly allocated again to receive chiropractic chronic pain management (CCPM) consisting of scheduled monthly chiropractic care for 10 months.

Other: Chiropractic Care

Phase 2: No CCPM

NO INTERVENTION

After Phase 1, Veterans with cLBP who will be randomly allocated again to receive no CCPM in which they will receive no chiropractic care for 10 months.

Interventions

Chiropractic Care OTHER

Chiropractic interventions: 1. Patient education. 2. Passive interventions, such as spinal manipulation and myofascial therapies which include thrust type (high velocity-low amplitude) spinal manipulation for the low back, non-thrust manipulation (joint mobilization), and use of manually held instruments, such as an Activator. Myofascial therapies are also commonly used, such as myofascial release and trigger point therapy. 3. Transitional interventions, such as therapeutic exercise. 4. Recommendations for active interventions, such as general exercise and mind-body therapies. 5. Self-management advice, which refers to advice given to build the capacity of a person to self-monitor, control, and/or reduce the impact of a condition over time.

Also known as: Manipulation, Chiropractic

Phase 1: Higher Dose (8-12 visits); Phase 1: Low Dose (1-5 visits); Phase 2: CCPM

Eligibility Criteria

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

You may qualify if:

• Veterans aged ≥ 18 years
• Self-reported cLBP
• Has low back related pain and disability
• Able to comprehend study details without need for a proxy
• Diagnostic confirmation of neuromusculoskeletal LBP
• Willing and able to attend up to 1 year of outpatient chiropractic visits

You may not qualify if:

• Any condition prohibiting or contraindicating chiropractic care
• Inability to complete outcomes and/or provide informed consent as determined by the site SC during the consent process
• Established plans to move within 3 months
• Under active chiropractic care
• No phone
• No email address
• Participating in another study investigating treatment(s) for pain
• Current or planned hospice care
• Current or planned pregnancy

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• Yale University: collaborator
• University of Iowa: collaborator
• Dartmouth College: collaborator
• VA Connecticut Healthcare System: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator
• Iowa City VA Health Care System: collaborator
• VA Greater Los Angeles Healthcare System: collaborator
• Office of Research on Women's Health (ORWH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Duke University: collaborator

Study Sites (4)

VA Greater Los Angeles Health Care System

Los Angeles, California, 90073, United States

Location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Iowa City VA Health Care System

Iowa City, Iowa, 52246, United States

Location

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (3)

• Long CR, Lisi AJ, Vining RD, Wallace RB, Salsbury SA, Shannon ZK, Halloran S, Minkalis AL, Corber L, Shekelle PG, Krebs EE, Abrams TE, Lurie JD, Goertz CM. Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain. Pain Med. 2020 Dec 12;21(Suppl 2):S37-S44. doi: 10.1093/pm/pnaa289.

  PMID: 33313732 BACKGROUND

• Lisi AJ, Salsbury SA, Hawk C, Vining RD, Wallace RB, Branson R, Long CR, Burgo-Black AL, Goertz CM. Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process. J Manipulative Physiol Ther. 2018 Feb;41(2):137-148. doi: 10.1016/j.jmpt.2017.10.001.

  PMID: 29482827 BACKGROUND

• Salsbury SA, Long CR, McCarey J, Lisi AJ, Steward A, Wallace RB, Goertz CM. Age differences in demographic and clinical characteristics among veterans with chronic low back pain: a cross-sectional study of baseline findings from the Veteran Response to Dosage in Chiropractic Therapy (VERDICT) trial. Chiropr Man Therap. 2025 Oct 13;33(1):44. doi: 10.1186/s12998-025-00613-z.

  PMID: 41084026 DERIVED

Related Links

• Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process
• Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain

MeSH Terms

Conditions

Low Back Pain; Patient Acceptance of Health Care; Bronchiolitis Obliterans Syndrome; Agnosia

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Christine Goertz, DC, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Cynthia Long, PhD

  Palmer Center for Chiropractic Research (PCCR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Doctors of Chiropractic (DCs), site study coordinators (SCs), participants and interviewers will not be blinded to treatment group assignment; DCs will not see research outcome measures; statisticians will be blinded to treatment group assignment during data analysis; and research personnel conducting Computerized Adaptive Testing Interviews (CATIs) will be blinded to study group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pragmatic, parallel groups, multisite randomized trial will include Veterans with cLBP who will be randomly allocated to undergo a course of a low dose (1-5 visits) or a higher dose (8-12 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1). Group allocation will occur through a 1:1 ratio by a predetermined, computer-generated, restricted randomization scheme with random block sizes, stratified by site and sex. After Phase 1, participants within each treatment arm will be randomly allocated again to receive either chiropractic chronic pain management (CCPM) consisting of scheduled monthly chiropractic care or no CCPM for 10 months. This second group allocation will also occur through a 1:1 ratio to Phase 2 within low dose or higher dose in Phase 1 by a predetermined, computer-generated, restricted randomization scheme with random block sizes, stratified by site and sex.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 12, 2019
• Study Start: February 22, 2021
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)