- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04087291
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 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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Cobb, DC, MS
- Phone Number: 563-884-5162
- Email: anna.waldencobb@palmer.edu
Study Contact Backup
- Name: Cynthia Long, PhD
- Phone Number: 563-884-5157
- Email: long_c@palmer.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90073
- Recruiting
- VA Greater Los Angeles Health Care System
-
Contact:
- Paul Shekelle, MD, PhD
- Phone Number: 310-478-3711
- Email: paul.shekelle@va.gov
-
Contact:
- Mel Valle
- Phone Number: 563-594-9386
- Email: melvin.valle-amaya@va.gov
-
-
Connecticut
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West Haven, Connecticut, United States, 06516
- Recruiting
- VA Connecticut Healthcare System
-
Contact:
- Anthony Lisi, DC
- Phone Number: 5341 203-932-5711
- Email: anthony.lisi@va.gov
-
Contact:
- Kena McDermott, DC
- Phone Number: 475-414-1476
- Email: kena.mcdermott@va.gov
-
-
Iowa
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Iowa City, Iowa, United States, 52246
- Recruiting
- Iowa City VA Health Care System
-
Contact:
- Anna L Cobb, DC, MS
- Phone Number: 563-949-0676
- Email: anna.waldencobb@palmer.edu
-
Contact:
- Elissa Twist, DC, MS
- Phone Number: 563-884-5891
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55417
- Recruiting
- Minneapolis VA Health Care System
-
Contact:
- Richard Branson, DC
- Phone Number: 612-467-5336
- Email: richard.branson@va.gov
-
Contact:
- Rebecca Rudquist
- Phone Number: 612-806-3776
- Email: rebecca.rudquist@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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).
|
Chiropractic interventions:
Other Names:
|
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).
|
Chiropractic interventions:
Other Names:
|
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.
|
Chiropractic interventions:
Other Names:
|
No Intervention: Phase 2: No CCPM
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Low Back Pain Disability at several time points - Roland Morris Disability Questionnaire (RMDQ)
Time Frame: 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.
|
At Baseline and Weeks 5, 10, 26, 40, and 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthcare Services Utilization
Time Frame: 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.
|
52 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Goertz, DC, PhD, Duke University
- Principal Investigator: Cynthia Long, PhD, Palmer Center for Chiropractic Research (PCCR)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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