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Veterans Response to Dosage in Chiropractic Therapy (VERDICT)

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ClinicalTrials.gov Identifier: NCT04087291
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
Yale University
University of Iowa
Dartmouth College
VA Connecticut Healthcare System
Minneapolis Veterans Affairs Medical Center
Iowa City VA Health Care System
VA Greater Los Angeles Healthcare System
Office of Research on Women's Health (ORWH)
National Center for Complementary and Integrative Health (NCCIH)
Duke University
Information provided by (Responsible Party):
Palmer College of Chiropractic

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Patient Acceptance of Health Care Veterans Health Other: Chiropractic Care Not Applicable

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.

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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 3, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


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).
Other: Chiropractic Care

Chiropractic interventions:

  1. Patient education.
  2. Passive interventions, such as spinal manipulation and myofascial therapies which include thrust type (high velocity-low amplitude) spinal manipulation for the low back, non-thrust manipulation (joint mobilization), and use of manually held instruments, such as an Activator. Myofascial therapies are also commonly used, such as myofascial release and trigger point therapy.
  3. Transitional interventions, such as therapeutic exercise.
  4. Recommendations for active interventions, such as general exercise and mind-body therapies.
  5. Self-management advice, which refers to advice given to build the capacity of a person to self-monitor, control, and/or reduce the impact of a condition over time.
Other Name: Manipulation, Chiropractic

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).
Other: Chiropractic Care

Chiropractic interventions:

  1. Patient education.
  2. Passive interventions, such as spinal manipulation and myofascial therapies which include thrust type (high velocity-low amplitude) spinal manipulation for the low back, non-thrust manipulation (joint mobilization), and use of manually held instruments, such as an Activator. Myofascial therapies are also commonly used, such as myofascial release and trigger point therapy.
  3. Transitional interventions, such as therapeutic exercise.
  4. Recommendations for active interventions, such as general exercise and mind-body therapies.
  5. Self-management advice, which refers to advice given to build the capacity of a person to self-monitor, control, and/or reduce the impact of a condition over time.
Other Name: Manipulation, Chiropractic

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.
Other: Chiropractic Care

Chiropractic interventions:

  1. Patient education.
  2. Passive interventions, such as spinal manipulation and myofascial therapies which include thrust type (high velocity-low amplitude) spinal manipulation for the low back, non-thrust manipulation (joint mobilization), and use of manually held instruments, such as an Activator. Myofascial therapies are also commonly used, such as myofascial release and trigger point therapy.
  3. Transitional interventions, such as therapeutic exercise.
  4. Recommendations for active interventions, such as general exercise and mind-body therapies.
  5. Self-management advice, which refers to advice given to build the capacity of a person to self-monitor, control, and/or reduce the impact of a condition over time.
Other Name: Manipulation, Chiropractic

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Anna Cobb, DC, MS 563-884-5162 anna.waldencobb@palmer.edu
Contact: Cynthia Long, PhD 563-884-5157 long_c@palmer.edu

Locations
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United States, California
VA Greater Los Angeles Health Care System Not yet recruiting
Los Angeles, California, United States, 90073
Contact: Paul Shekelle, MD, PhD    310-478-3711    paul.shekelle@va.gov   
United States, Connecticut
VA Connecticut Healthcare System Not yet recruiting
West Haven, Connecticut, United States, 06516
Contact: Anthony Lisi, DC    203-932-5711 ext 5341    anthony.lisi@va.gov   
United States, Iowa
Iowa City VA Health Care System Recruiting
Iowa City, Iowa, United States, 52246
Contact: Anna L Cobb, DC, MS    563-639-5939    anna.waldencobb@palmer.edu   
Contact: Elissa Twist, DC, MS    563-884-5891      
United States, Minnesota
Minneapolis VA Health Care System Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Richard Branson, DC    612-467-5336    richard.branson@va.gov   
Sponsors and Collaborators
Palmer College of Chiropractic
Yale University
University of Iowa
Dartmouth College
VA Connecticut Healthcare System
Minneapolis Veterans Affairs Medical Center
Iowa City VA Health Care System
VA Greater Los Angeles Healthcare System
Office of Research on Women's Health (ORWH)
National Center for Complementary and Integrative Health (NCCIH)
Duke University
Investigators
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Principal Investigator: Christine Goertz, DC, PhD Duke University
Principal Investigator: Cynthia Long, PhD Palmer Center for Chiropractic Research (PCCR)
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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: March 9, 2021
Last Verified: March 2021
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Palmer College of Chiropractic:
chronic
pain management
manipulation, chiropractic
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations