Veterans Response to Dosage in Chiropractic Therapy
- Conditions
- Veterans HealthLow Back PainPatient Acceptance of Health Care
- Interventions
- Other: Chiropractic Care
- Registration Number
- NCT04087291
- Lead Sponsor
- Palmer College of Chiropractic
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 766
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 2: CCPM Chiropractic Care 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. Phase 1: Low Dose (1-5 visits) Chiropractic Care 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). Phase 1: Higher Dose (8-12 visits) Chiropractic Care 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).
- Primary Outcome Measures
Name Time Method Change from Baseline Low Back Pain Disability at several time points - Roland Morris Disability Questionnaire (RMDQ) At Baseline and Weeks 5, 10, 26, 40, and 52 A one-page, 24-item questionnaire related to low back pain disability. The RMDQ can discriminate between different forms of treatment for back pain, and is sensitive to clinical change.
- Secondary Outcome Measures
Name Time Method Healthcare Services Utilization 52 weeks We will assess all healthcare services used by each participant during the study period including the clinics seen, number of visits, orders, investigations, and prescriptions. We will estimate costs for these services using Decision Support System69 data. We will assess differences in cLBP-related healthcare utilization in the 4 treatment groups (low dose-CCPM, low dose-no CCPM, higher dose-CCPM, higher dose-no CCPM). In addition, we will investigate differences in health care utilization between sites.
Trial Locations
- Locations (4)
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
VA Greater Los Angeles Health Care System
🇺🇸Los Angeles, California, United States
Iowa City VA Health Care System
🇺🇸Iowa City, Iowa, United States
VA Connecticut Healthcare System
🇺🇸West Haven, Connecticut, United States