Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain

Author:

Long Cynthia R1,Lisi Anthony J2,Vining Robert D1,Wallace Robert B3,Salsbury Stacie A1,Shannon Zacariah K1,Halloran Stephanie4,Minkalis Amy L1,Corber Lance1,Shekelle Paul G5,Krebs Erin E6,Abrams Thad E7,Lurie Jon D8,Goertz Christine M9

Affiliation:

1. Palmer College of Chiropractic, Davenport, Iowa

2. Yale School of Medicine-Center for Medical Informatics, Yale University, New Haven, Connecticut

3. The University of Iowa, College of Public Health, Iowa City, Iowa

4. Yale Center for Medical Informatics, New Haven, Connecticut

5. VA Greater Los Angeles Healthcare System, Los Angeles, California

6. Minneapolis VA Health Care System, Minneapolis, Minnesota

7. Iowa City VA Health Care System, Iowa City, Iowa

8. The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire

9. Duke University, Durham, North Carolina, USA

Abstract

Conflicts of interest: No potential conflicts exist for any author listed.Abstract Background Low back pain is a leading cause of disability in veterans. Chiropractic care is a well-integrated, nonpharmacological therapy in Veterans Affairs health care facilities, where doctors of chiropractic provide therapeutic interventions focused on the management of low back pain and other musculoskeletal conditions. However, important knowledge gaps remain regarding the effectiveness of chiropractic care in terms of the number and frequency of treatment visits needed for optimal outcomes in veterans with low back pain. Design This pragmatic, parallel-group randomized trial at four Veterans Affairs sites will include 766 veterans with chronic low back pain who are randomly allocated to a course of low-dose (one to five visits) or higher-dose (eight to 12 visits) chiropractic care for 10 weeks (Phase 1). After Phase 1, participants within each treatment arm will again be randomly allocated to receive either monthly chiropractic chronic pain management for 10 months or no scheduled chiropractic visits (Phase 2). Assessments will be collected electronically. The Roland Morris Disability Questionnaire will be the primary outcome for Phase 1 at week 10 and Phase 2 at week 52. Summary This trial will provide evidence to guide the chiropractic dose in an initial course of care and an extended-care approach for veterans with chronic low back pain. Accurate information on the effectiveness of different dosing regimens of chiropractic care can greatly assist health care facilities, including Veterans Affairs, in modeling the number of doctors of chiropractic that will best meet the needs of patients with chronic low back pain.

Funder

National Institutes of Health

National Center for Complementary and Integrative Health

Office of Research on Women’s Health

NCCIH

Publisher

Oxford University Press (OUP)

Subject

Anesthesiology and Pain Medicine,Clinical Neurology,General Medicine

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