Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial

Background: Neck pain presents a personal and socioeconomic burden globally. Despite increasing prevalence, research on chronic neck pain (CNP) is limited and management relies on generalized approaches. There is growing interest in non-pharmacological interventions, however their efficacy remains u...

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Main Authors: Peter M. Wayne, Robert Vining, Cynthia R. Long, Wren M. Burton, Daniel Litrownik, Jacqueline Guzman, Karen Kilgore, Thomas J. Hagan, Pamela M. Rist, Matthew H. Kowalski
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Contemporary Clinical Trials Communications
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Online Access:http://www.sciencedirect.com/science/article/pii/S2451865425000560
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Summary:Background: Neck pain presents a personal and socioeconomic burden globally. Despite increasing prevalence, research on chronic neck pain (CNP) is limited and management relies on generalized approaches. There is growing interest in non-pharmacological interventions, however their efficacy remains uncertain due to the multifactorial etiology of CNP. Two interventions, multimodal chiropractic care (MCC) and Tai Chi, have shown promise individually in managing CNP, and when combined may offer synergistic benefits. This pilot study aims to assess the feasibility of combining these interventions for CNP.Methods/design: Forty-eight adults, aged 18-65y, with CNP defined as occurring ≥5 days a week for ≥3 consecutive months, severity of ≥3 on the numeric rating scale, and a score of ≥5 on the Neck Disability Index will be recruited. Participants will be randomized 1:1:1 to one of the three treatment groups (MCC plus Tai Chi and Enhanced Usual Care (EUC), MCC plus EUC, or EUC alone). The MCC was validated using a modified Delphi approach. Primary outcomes relate to feasibility (recruitment, retention, and adherence) and secondary outcomes include clinical measures of neck pain severity and disability, health-related quality-of-life, psychosocial well-being, and physical function. Outcomes will be assessed at baseline, 16-weeks (post-intervention), and 24-weeks. Qualitative interviews will be conducted. Discussion: Results of this study will provide preliminary evidence regarding the feasibility and clinical evaluation of pragmatically delivered MCC, alone or in combination with Tai Chi, for individuals with CNP. These data will be used to inform the design of a fully powered, factorial trial evaluating two promising non-pharmacological therapies for CNP. Trial registration: This study is registered in ClinicalTrials.gov (NCT05726331).
ISSN:2451-8654