Veterans Response to Dosage in Chiropractic Therapy

Low Back Pain Clinical Trial

— VERDICT  

Official title:

VERDICT (Veterans Response to Dosage in Chiropractic Therapy): A Pragmatic Randomized Trial Addressing Dose Effects for Chronic Low Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04087291
• Other study ID #: 18-34
• Secondary ID: UH3AT009761
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: Palmer College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 766
• Est. completion date: May 31, 2025
• Est. primary completion date: May 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Patient Acceptance of Health Care
• Veterans Health

Intervention

Other:
• Chiropractic Care
Chiropractic interventions: Patient education. 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. Transitional interventions, such as therapeutic exercise. Recommendations for active interventions, such as general exercise and mind-body therapies. 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.

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System	Iowa City	Iowa
United States	VA Greater Los Angeles Health Care System	Los Angeles	California
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (11)

Lead Sponsor	Collaborator
Palmer College of Chiropractic	Dartmouth College, Duke University, Iowa City VA Health Care System, Minneapolis Veterans Affairs Medical Center, National Center for Complementary and Integrative Health (NCCIH), Office of Research on Women's Health (ORWH), University of Iowa, VA Connecticut Healthcare System, VA Greater Los Angeles Healthcare System, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Low Back Pain Disability at several time points - Roland Morris Disability Questionnaire (RMDQ)	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.	At Baseline and Weeks 5, 10, 26, 40, and 52
Secondary	Healthcare Services Utilization	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.	52 weeks

External Links

•   Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process
•   Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain