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Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a single-arm, pragmatic, pilot trial of multimodal chiropractic care for U.S. veterans with chronic low back pain
Journal article   Open access   Peer reviewed

Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a single-arm, pragmatic, pilot trial of multimodal chiropractic care for U.S. veterans with chronic low back pain

Cynthia R Long, Stacie A Salsbury, Robert D Vining, Anthony J Lisi, Lance Corber, Elissa Twist, Thad Abrams, Robert B Wallace and Christine M Goertz
Pilot and feasibility studies, Vol.8(1), pp.54-54
03/07/2022
DOI: 10.1186/s40814-022-01008-0
PMCID: PMC8900358
PMID: 35256010
url
https://doi.org/10.1186/s40814-022-01008-0View
Published (Version of record) Open Access

Abstract

Over 25% of veterans seeking care at U.S. Veterans Health Administration facilities have chronic low back pain (LBP), with high rates of mental health comorbidities. The primary objective of this study was to assess the feasibility of participant recruitment, retention, and electronic data collection to prepare for the subsequent randomized trial of multimodal chiropractic care for pain management of veterans with chronic low back pain. The secondary objectives were to estimate effect sizes and variability of the primary outcome and choose secondary outcomes for the full-scale trial. This single-arm pilot trial enrolled 40 veterans with chronic LBP at one Veterans Health Administration facility for a 10-week course of pragmatic multimodal chiropractic care. Recruitment was by (1) provider referral, (2) invitational letter from the electronic health record pre-screening, and (3) standard direct recruitment. We administered patient-reported outcome assessments through an email link to REDCap, an electronic data capture platform, at baseline and 5 additional timepoints. Retention was tracked through adherence to the treatment plan and completion rates of outcome assessments. Descriptive statistics were calculated for baseline characteristics and outcome variables. We screened 91 veterans over 6 months to enroll our goal of 40 participants. Seventy percent were recruited through provider referrals. Mean age (range) was 53 (22-79) years and 23% were female; 95% had mental health comorbidities. The mean number of chiropractic visits was 4.5 (1-7). Participants adhered to their treatment plan, with exception of 3 who attended only their first visit. All participants completed assessments at the in-person baseline visit and 80% at the week 10 final endpoint. We had no issues administering assessments via REDCap. We observed clinically important improvements on the Roland-Morris Disability Questionnaire [mean change (SD): 3.6 (6.1)] and on PROMIS® pain interference [mean change (SD): 3.6 (5.6)], which will be our primary and key secondary outcome, respectively, for the full-scale trial. We demonstrated the feasibility of participant recruitment, retention, and electronic data collection for conducting a pragmatic clinical trial of chiropractic care in a Veterans Health Administration facility. Using the pilot data and lessons learned, we modified and refined a protocol for a full-scale, multisite, pragmatic, National Institutes of Health-funded randomized trial of multimodal chiropractic care for veterans with chronic LBP that began recruitment in February 2021. ClinicalTrials.gov NCT03254719.
 Nonpharmacologic Chiropractic Pilot projects Veterans Low back pain Patient-reported outcome measures Pain management Chronic pain

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