Veterans Response to Dosage in Chiropractic Therapy (VERDICT)

VERDICT (Veterans Response to Dosage in Chiropractic Therapy): A Pragmatic Randomized Trial Addressing Dose Effects for Chronic Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Patient Acceptance of Health Care; Veterans Health
• Intervention / Treatment: Other: Chiropractic Care

Detailed Description

The combination of chronic low back pain (cLBP) and high medication use negatively impacts Veterans' work productivity and quality of life, and generates substantial risk for long-term disability and opioid addiction. Although non-pharmacological therapies, such as those commonly used by doctors of chiropractic (DCs), are recommended by recent guidelines for treatment of cLBP, the optimal patterns of chiropractic use, clinical impact of chiropractic treatment on other health services utilization, and long-term effectiveness of chiropractic care is unknown.

This is a pragmatic, parallel groups, multisite randomized trial. Veterans with cLBP are 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). The investigators hypothesize that a higher dose (8-12 visits) of chiropractic care will be more effective in improving function and reducing pain intensity and pain-related interference in Veterans with cLBP compared to a low dose (1-5 visits).

After Phase 1, participants within each treatment arm will be randomly allocated again to receive either chronic chiropractic pain management (CCPM) consisting of scheduled monthly chiropractic care or no CCPM for 10 months. The investigators hypothesize that CCPM (1 scheduled chiropractic visit per month x 10 months) will result in improved function, and reduced pain intensity, pain-related interference, and average number of days per week with low back pain (LBP) in Veterans with cLBP compared to no CCPM.

This study will also evaluate the impact of CCPM on health services outcomes compared to no CCPM. Evaluation of health services utilization at 52 weeks will include use of prescription medications, including opioids, referrals and number of visits to other healthcare professionals or service lines (physical therapy, injections, surgery, etc.), and hospitalizations for any cause and for cLBP.

Finally, the investigators will evaluate patient and clinician perceptions of non-specific treatment factors, effectiveness of study interventions, and impact of the varying doses of standard chiropractic care and the CCPM on clinical outcomes across 4 VA facilities using a mixed method, process evaluation approach.

• Study Type: Interventional
• Enrollment (Actual): 766
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Health Care System
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System
  • Iowa
    • Iowa City, Iowa, United States, 52246
      • Iowa City VA Health Care System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phase 1: Low Dose (1-5 visits); 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; Chiropractic interventions: Patient education.; 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.; Transitional interventions, such as therapeutic exercise.; Recommendations for active interventions, such as general exercise and mind-body therapies.; 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.; Other Names: Manipulation, Chiropractic
Active Comparator: Phase 1: Higher Dose (8-12 visits); 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; Chiropractic interventions: Patient education.; 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.; Transitional interventions, such as therapeutic exercise.; Recommendations for active interventions, such as general exercise and mind-body therapies.; 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.; Other Names: Manipulation, Chiropractic
Active Comparator: Phase 2: CCPM; 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; Chiropractic interventions: Patient education.; 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.; Transitional interventions, such as therapeutic exercise.; Recommendations for active interventions, such as general exercise and mind-body therapies.; 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.; Other Names: Manipulation, Chiropractic
No Intervention: Phase 2: No CCPM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Back Pain Intensity Change From Baseline to Week 10	Low back pain intensity was measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 = no pain and 10 = worst pain imaginable. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain.	Baseline to Week 10
PEG Pain Severity Change From Baseline to Week 10	PEG (Pain, Enjoyment of life, General activity) scale assessing pain intensity and interference. Scores range from 0 to 10 (mean of 3 items). Higher scores indicate worse pain and greater interference; lower scores indicate less pain and better function.	Baseline to Week 10
Physical and Social Health Change From Baseline to Week 10 (PROMIS)	PROMIS (Patient-Reported Outcomes Measurement Information System) domains assessed using standardized T-scores (mean=50, SD=10; range ~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better outcomes for Global Physical Health, Social Roles Satisfaction, and Global Mental Health. For Pain Interference, Fatigue, and Sleep Disturbance, higher scores indicate worse symptoms. Domains are scored separately.	Baseline to Week 10
Global Mental Health: Physical and Social Health Change From Baseline to Week 10 (PROMIS)	PROMIS Global Mental Health assessed using standardized T-scores (mean=50, SD=10; range ~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better mental health (better outcome), and lower scores indicate worse mental health.	Baseline to Week 10
Average Number of Days Per Week With Low Back Pain at Week 10	Self-reported number of days per week (range 0-7) with low back pain during the prior week. Higher values indicate more frequent pain (worse outcome), and lower values indicate fewer days with pain.	Week 10
Low Back Pain Intensity Change From Baseline to Week 52	Low back pain intensity was measured using the Numeric Rating Scale (NRS), a 0-10 scale where 0 = no pain and 10 = worst pain imaginable. Higher scores indicate greater pain intensity (worse outcome), and lower scores indicate less pain.	Baseline to Week 52
PEG Pain Severity Change From Baseline to Week 52	PEG (Pain, Enjoyment of life, General activity) scale assessing pain intensity and interference. Scores range from 0 to 10 (mean of 3 items). Higher scores indicate worse pain and greater interference; lower scores indicate less pain and better function.	Baseline to Week 52
Physical and Social Health Change From Baseline to Week 52 (PROMIS)	PROMIS (Patient-Reported Outcomes Measurement Information System) domains assessed using standardized T-scores (mean=50, SD=10; range ~20-80). A T-score of 50 represents the population mean; scores 10 points above or below represent one standard deviation. Higher scores indicate better outcomes for Global Physical Health, Social Roles Satisfaction, and Global Mental Health. For Pain Interference, Fatigue, and Sleep Disturbance, higher scores indicate worse symptoms. Domains are scored separately.	Baseline to Week 52
Average Number of Days Per Week With Low Back Pain at Week 52	Self-reported number of days per week (range 0-7) with low back pain during the prior week. Higher values indicate more frequent pain (worse outcome), and lower values indicate fewer days with pain.	Week 52

Collaborators and Investigators

• Sponsor: Palmer College of Chiropractic
• Collaborators: Yale University; Minneapolis Veterans Affairs Medical Center; University of Iowa; Duke University; VA Connecticut Healthcare System; National Center for Complementary and Integrative Health (NCCIH); Dartmouth College; VA Greater Los Angeles Healthcare System; Iowa City VA Health Care System
• Investigators: Principal Investigator: Christine Goertz, DC, PhD, Duke University; Principal Investigator: Cynthia Long, PhD, Palmer Center for Chiropractic Research (PCCR)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): May 20, 2025

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: chronic; pain management; manipulation, chiropractic
• Additional Relevant MeSH Terms: Organizing Pneumonia; Pain; Neurologic Manifestations; Nervous System Diseases; Immune System Diseases; Respiratory Tract Diseases; Neurobehavioral Manifestations; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Back Pain; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Perceptual Disorders; Graft vs Host Disease; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Bronchiolitis Obliterans Syndrome; Low Back Pain; Agnosia; Patient Acceptance of Health Care; Therapeutics; Complementary Therapies; Musculoskeletal Manipulations; Manipulation, Chiropractic
• Other Study ID Numbers: 18-34; UH3AT009761 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: VERDICT metadata are posted on the NIH HEAL Initiative HEAL Data Platform at https://healdata.org/portal/discovery/HDP01154/. Demographics and participant-reported data will be available in a HEAL-compliant repository after the primary manuscripts have been published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No