Veterans Response to Dosage in Chiropractic Therapy

NCT04087291 | Completed Results 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 be randomized to receive a low dose (1-5 visits) of chiropractic care for 10 weeks, while the other half will be randomized to 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 (2)

• Number of Participants With Clinically Meaningful Improvement in Back-Related Disability From Baseline to Week 10

  Proportion of participants achieving a clinically meaningful improvement in low back-related disability, defined as ≥30% relative improvement from baseline to 10 weeks in the Roland Morris Disability Questionnaire (RMDQ; range 0-24, higher scores indicate greater disability).

  Baseline to Week 10

• Back-Related Disability Change From Baseline to Week 52 (RMDQ)

  Back-related disability was measured using the Roland Morris Disability Questionnaire (RMDQ), a 24-item scale with scores ranging from 0 to 24. Higher scores indicate greater disability (worse outcome), and lower scores indicate less disability.

  Baseline to Week 52

Secondary Outcomes (9)

• Low Back Pain Intensity Change From Baseline to Week 10

  Baseline to Week 10

• PEG Pain Severity Change From Baseline to Week 10

  Baseline to Week 10

• Physical and Social Health Change From Baseline to Week 10 (PROMIS)

  Baseline to Week 10

• Global Mental Health: Physical and Social Health Change From Baseline to Week 10 (PROMIS)

  Baseline to Week 10

• Average Number of Days Per Week With Low Back Pain at Week 10

  Week 10

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

Participants who completed Phase 1 and consented to continue participation were re-randomized to receive no scheduled chiropractic visits during the 10-month follow-up period after the initial 10-week treatment phase, in addition to usual VA care. Participants could continue to access other VA healthcare services as clinically indicated.

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
• 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)

• Steward A, Salsbury SA, Vining RD, Twist E, McCarey J, Kedilaya S, Minkalis AL, Rudquist R, McDermott K, Shekelle PG, Abrams TE, Lurie JD, Wallace RB, Lisi AJ, Goertz CM, Long CR. Recruiting US veterans with chronic low back pain in a multisite randomized pragmatic trial. Trials. 2026 Mar 19;27(1):326. doi: 10.1186/s13063-026-09637-z.

  PMID: 41857686 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 BACKGROUND

• 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

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

Limitations and Caveats

Adherence to the higher-dose group in Phase 1 was a challenge. Our sample consisted of only veterans seeking care in VA healthcare facilities, and they were primarily already referred to chiropractic care. This may limit generalizability to other health systems and settings.

Results Point of Contact

• Title: Cynthia R. Long, PhD, PStat® | Professor, Dean of Research | Director-ODM & Biostatistics
• Organization: Palmer College of Chiropractic

LONG_C@palmer.edu

563-884-5157

Study Officials

• Christine Goertz, DC, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Cynthia Long, PhD

  Palmer Center for Chiropractic Research (PCCR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: TREATMENT
• 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: August 11, 2026
• Results First Posted: August 11, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)