Clinical trial NCT04087291: Veterans Response to Dosage in Chiropractic Therapy
Official title: VERDICT (Veterans Response to Dosage in Chiropractic Therapy): A Pragmatic Randomized Trial Addressing Dose Effects for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Patient Acceptance of Health Care
Veterans Health
Keywords: chronic
pain management
manipulation, chiropractic
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
Collaborators: name: Yale University
name: University of Iowa
name: Dartmouth College
name: VA Connecticut Healthcare System
name: Minneapolis Veterans Affairs Medical Center
name: Iowa City VA Health Care System
name: VA Greater Los Angeles Healthcare System
name: Office of Research on Women's Health (ORWH)
name: National Center for Complementary and Integrative Health (NCCIH)
name: Duke University
First posted: 2019-09-12
Enrollment: 766
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pragmatic, parallel groups, multisite randomized trial will include Veterans with cLBP who will be 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). Group allocation will occur through a 1:1 ratio by a predetermined, computer-generated, restricted randomization scheme with random block sizes, stratified by site and sex. After Phase 1, participants within each treatment arm will be randomly allocated again to receive either chiropractic chronic pain management (CCPM) consisting of scheduled monthly chiropractic care or no CCPM for 10 months. This second group allocation will also occur through a 1:1 ratio to Phase 2 within low dose or higher dose in Phase 1 by a predetermined, computer-generated, restricted randomization scheme with random block sizes, stratified by site and sex.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Healthcare Services Utilization
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Health Care System
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
city: Iowa City
country: United States
facility: Iowa City VA Health Care System
state: Iowa
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
affiliation: Duke University
name: Christine Goertz, DC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmer Center for Chiropractic Research (PCCR)
name: Cynthia Long, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Long CR, Lisi AJ, Vining RD, Wallace RB, Salsbury SA, Shannon ZK, Halloran S, Minkalis AL, Corber L, Shekelle PG, Krebs EE, Abrams TE, Lurie JD, Goertz CM. Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain. Pain Med. 2020 Dec 12;21(Suppl 2):S37-S44. doi: 10.1093/pm/pnaa289.
citation: Lisi AJ, Salsbury SA, Hawk C, Vining RD, Wallace RB, Branson R, Long CR, Burgo-Black AL, Goertz CM. Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process. J Manipulative Physiol Ther. 2018 Feb;41(2):137-148. doi: 10.1016/j.jmpt.2017.10.001.