Veterans Response to Dosage in Chiropractic Therapy

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    766
  • sponsor
    Palmer College of Chiropractic
Updated on 9 August 2021
back pain
manipulation
low back pain
chiropractic

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.

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.

Details
Condition Veterans Health, lumbago, Acceptors, Lower Back Pain, Chronic Back Pain, Low Back Pain, Back Pain
Treatment Chiropractic Care
Clinical Study IdentifierNCT04087291
SponsorPalmer College of Chiropractic
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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