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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
First received
Last updated
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


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
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