Veterans Response to Dosage in Chiropractic Therapy (VERDICT)
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| ClinicalTrials.gov Identifier: NCT04087291 |
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Recruitment Status :
Recruiting
First Posted : September 12, 2019
Last Update Posted : September 27, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Low Back Pain Patient Acceptance of Health Care Veterans Health | Other: Chiropractic Care | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 766 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Masking Description: | Doctors of Chiropractic (DCs), site study coordinators (SCs), participants and interviewers will not be blinded to treatment group assignment; DCs will not see research outcome measures; statisticians will be blinded to treatment group assignment during data analysis; and research personnel conducting Computerized Adaptive Testing Interviews (CATIs) will be blinded to study group. |
| Primary Purpose: | Health Services Research |
| Official Title: | VERDICT (Veterans Response to Dosage in Chiropractic Therapy): A Pragmatic Randomized Trial Addressing Dose Effects for Chronic Low Back Pain |
| Actual Study Start Date : | February 23, 2021 |
| Estimated Primary Completion Date : | August 31, 2024 |
| Estimated Study Completion Date : | August 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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).
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Other: Chiropractic Care
Chiropractic interventions:
Other Name: Manipulation, Chiropractic |
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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).
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Other: Chiropractic Care
Chiropractic interventions:
Other Name: Manipulation, Chiropractic |
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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.
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Other: Chiropractic Care
Chiropractic interventions:
Other Name: Manipulation, Chiropractic |
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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.
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- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087291
| Contact: Anna Cobb, DC, MS | 563-884-5162 | anna.waldencobb@palmer.edu | |
| Contact: Cynthia Long, PhD | 563-884-5157 | long_c@palmer.edu |
| United States, California | |
| VA Greater Los Angeles Health Care System | Recruiting |
| Los Angeles, California, United States, 90073 | |
| Contact: Paul Shekelle, MD, PhD 310-478-3711 paul.shekelle@va.gov | |
| Contact: Mel Valle 563-594-9386 melvin.valle-amaya@va.gov | |
| United States, Connecticut | |
| VA Connecticut Healthcare System | Recruiting |
| West Haven, Connecticut, United States, 06516 | |
| Contact: Anthony Lisi, DC 203-932-5711 ext 5341 anthony.lisi@va.gov | |
| Contact: Kena McDermott, DC 475-414-1476 kena.mcdermott@va.gov | |
| United States, Iowa | |
| Iowa City VA Health Care System | Recruiting |
| Iowa City, Iowa, United States, 52246 | |
| Contact: Anna L Cobb, DC, MS 563-949-0676 anna.waldencobb@palmer.edu | |
| Contact: Elissa Twist, DC, MS 563-884-5891 | |
| United States, Minnesota | |
| Minneapolis VA Health Care System | Recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Contact: Richard Branson, DC 612-467-5336 richard.branson@va.gov | |
| Contact: Rebecca Rudquist 612-806-3776 rebecca.rudquist@va.gov | |
| Principal Investigator: | Christine Goertz, DC, PhD | Duke University | |
| Principal Investigator: | Cynthia Long, PhD | Palmer Center for Chiropractic Research (PCCR) |
| Responsible Party: | Palmer College of Chiropractic |
| ClinicalTrials.gov Identifier: | NCT04087291 |
| Other Study ID Numbers: |
18-34 UH3AT009761 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 12, 2019 Key Record Dates |
| Last Update Posted: | September 27, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified, limited data sets that are transmitted to the requesting parties for additional analyses. In order to safeguard patient confidentiality and scientific integrity, the investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) evidence of local IRB approval from the requesting party's home institution; (2) a commitment to use the data only for research purposes and not to identify any individual participant; (3) a commitment to secure the data using appropriate computer technology to protect the privacy and security of the individual participant; (4) a commitment to destroy or return the data after analyses are completed; and (5) an assurance to use the data in compliance with all applicable statutes and regulations, including but not limited to the HIPAA. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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chronic pain management manipulation, chiropractic |
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Back Pain Low Back Pain Pain Neurologic Manifestations |