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Low Back PainVERDICTNCT04087291

Veterans Response to Dosage in Chiropractic Therapy

A study testing Chiropractic Care in people with Low Back Pain and Patient Acceptance of Health Care, run by Palmer College of Chiropractic at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chiropractic Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
766 participants
Where
4 sitesUnited States
Study dates
22 Feb 2021to 20 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Participating in another study investigating treatment(s) for pain
  • Current or planned hospice care
  • Current or planned pregnancy

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Iowa City VA Health Care System

    Iowa City, Iowa, 52246

  • VA Greater Los Angeles Health Care System

    Los Angeles, California, 90073

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota, 55417

  • VA Connecticut Healthcare System

    West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Chiropractic Care
Keywords
chronic, pain management, manipulation, chiropractic
Medical subject headings
Low Back Pain, Patient Acceptance of Health Care, Bronchiolitis Obliterans Syndrome, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chiropractic CareOther

    Also called Manipulation, Chiropractic

    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.
Study groups in NCT04087291
Study groupRoleWhat they receive
Phase 1: Low Dose (1-5 visits)Active comparatorVeterans 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).
Receives: Other: Chiropractic Care
Phase 1: Higher Dose (8-12 visits)Active comparatorVeterans 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).
Receives: Other: Chiropractic Care
Phase 2: CCPMActive comparatorAfter 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.
Receives: Other: Chiropractic Care
Phase 2: No CCPMNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline to Week 10

  2. 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.

    Measured: Baseline to Week 52

Secondary outcomes (9)
  1. 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.

    Measured: Baseline to Week 10

  2. 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.

    Measured: Baseline to Week 10

  3. 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.

    Measured: Baseline to Week 10

  4. 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.

    Measured: Baseline to Week 10

  5. 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.

    Measured: Week 10

  6. 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.

    Measured: Baseline to Week 52

  7. 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.

    Measured: Baseline to Week 52

  8. 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.

    Measured: Baseline to Week 52

  9. 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.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2019
  2. Study start22 Feb 2021
  3. Primary completion20 May 2025
  4. Study completion20 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04087291
Sponsor's protocol ID
18-34
Other IDs
UH3AT009761
Acronym
VERDICT
Status last verified
Jul 2026
First submitted
27 Aug 2019
Last updated
11 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 41857686
  • 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.

    PubMed 41084026
  • 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.

    PubMed 33313732

Questions about this trial

What is this clinical trial studying?

A study testing Chiropractic Care in people with Low Back Pain and Patient Acceptance of Health Care, run by Palmer College of Chiropractic at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Meaningful Improvement in Back-Related Disability From Baseline to Week 10 (time frame: Baseline to Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04087291, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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