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NCT Number: NCT04087291

Veterans Response to Dosage in Chiropractic Therapy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Greater Los Angeles Health Care System, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chiropractic care

Other

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

Primary outcomes

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

    Time frame: 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).

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

    Time frame: Baseline to Week 52

    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.

Secondary outcomes

  1. Low Back Pain Intensity Change From Baseline to Week 10

    Time frame: 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.

  2. PEG Pain Severity Change From Baseline to Week 10

    Time frame: 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.

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

    Time frame: Baseline to Week 10

    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.

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

    Time frame: Baseline to Week 10

    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.

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

    Time frame: 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.

  6. Low Back Pain Intensity Change From Baseline to Week 52

    Time frame: 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.

  7. PEG Pain Severity Change From Baseline to Week 52

    Time frame: 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.

  8. Physical and Social Health Change From Baseline to Week 52 (PROMIS)

    Time frame: Baseline to Week 52

    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.

  9. Average Number of Days Per Week With Low Back Pain at Week 52

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Palmer College of Chiropractic

Other

Collaborators

  • Dartmouth College
  • Duke University
  • Iowa City VA Health Care System
  • Minneapolis Veterans Affairs Medical Center
  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Iowa
  • VA Connecticut Healthcare System
  • VA Greater Los Angeles Healthcare System
  • Yale University

Registry information

Official study title

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

Acronym: VERDICT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2019
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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