Veterans Response to Dosage in Chiropractic Therapy (NCT04087291) | Clinical Trial Compass
CompletedNot Applicable
Veterans Response to Dosage in Chiropractic Therapy
United States766 participantsStarted 2021-02-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline Low Back Pain Disability at several time points - Roland Morris Disability Questionnaire (RMDQ)
Timeframe: At Baseline and Weeks 5, 10, 26, 40, and 52