Veterans Response to Dosage in Chiropractic Therapy (VERDICT)

Palmer College of Chiropractic

Status: Active, not recruiting

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

Treatments: Other: Chiropractic Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04087291

18-34

UH3AT009761 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 766 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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766 participants in 4 patient groups

Phase 1: Low Dose (1-5 visits)

Active Comparator group

Description:

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).

Treatment:

Other: Chiropractic Care

Phase 1: Higher Dose (8-12 visits)

Active Comparator group

Description:

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).

Treatment:

Other: Chiropractic Care

Phase 2: CCPM

Active Comparator group

Description:

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.

Treatment:

Other: Chiropractic Care

Phase 2: No CCPM

No Intervention group

Description:

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.