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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-04-11 DOI:10.1016/j.conctc.2025.101482

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

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引用次数: 0

Abstract

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).

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脊椎指压疗法和太极拳联合治疗慢性颈部疼痛：一项随机试验方案

颈痛是全球范围内的个人和社会经济负担。尽管越来越普遍，慢性颈部疼痛（CNP）的研究是有限的，管理依赖于广义的方法。人们对非药物干预越来越感兴趣，但由于CNP的多因素病因，其疗效仍不确定。两种干预措施，多模式脊椎指压治疗（MCC）和太极，在单独治疗CNP方面显示出希望，当联合使用时可能会产生协同效益。这项试点研究旨在评估将这些干预措施结合起来治疗CNP的可行性。方法/设计：招募48名成年人，年龄18-65岁，CNP定义为每周发生≥5天，连续≥3个月，数字评定量表严重程度≥3，颈部残疾指数得分≥5。参与者将以1:1:1的比例随机分配到三个治疗组（MCC +太极和强化常规护理（EUC）， MCC + EUC或单独EUC）中的一个。采用改进的德尔菲法对MCC进行验证。主要结局与可行性有关（招募、保留和坚持），次要结局包括颈部疼痛严重程度和残疾、健康相关生活质量、社会心理健康和身体功能的临床测量。结果将在基线、16周（干预后）和24周进行评估。将进行定性访谈。本研究的结果将为实际提供MCC的可行性和临床评估提供初步证据，单独或联合太极，用于CNP患者。这些数据将用于设计一项全动力、析因试验，评估两种有希望的CNP非药物治疗方法。试验注册本研究已在ClinicalTrials.gov注册（NCT05726331）。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.