Wayne Peter M, Vining Robert, Long Cynthia R, Burton Wren M, Litrownik Daniel, Guzman Jacqueline, Kilgore Karen, Hagan Thomas J, Rist Pamela M, Kowalski Matthew H
Osher Center for Integrative Health, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Contemp Clin Trials Commun. 2025 Apr 11;45:101482. doi: 10.1016/j.conctc.2025.101482. eCollection 2025 Jun.
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.
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.
This study is registered in ClinicalTrials.gov (NCT05726331).
颈部疼痛在全球范围内给个人和社会经济带来负担。尽管患病率不断上升,但对慢性颈部疼痛(CNP)的研究有限,其管理依赖于通用方法。人们对非药物干预的兴趣日益浓厚,然而,由于CNP的多因素病因,其疗效仍不确定。两种干预措施,多模式整脊疗法(MCC)和太极拳,在单独管理CNP方面已显示出前景,并且联合使用可能会带来协同效益。这项试点研究旨在评估联合使用这些干预措施治疗CNP的可行性。
方法/设计:将招募48名年龄在18 - 65岁之间的成年人,他们患有CNP,定义为每周发作≥5天,持续≥3个月,数字评分量表严重程度≥3,颈部残疾指数得分≥5。参与者将按1:1:1随机分配到三个治疗组之一(MCC加太极拳和强化常规护理(EUC)、MCC加EUC或仅EUC)。MCC采用改良的德尔菲法进行验证。主要结局与可行性(招募、保留率和依从性)相关,次要结局包括颈部疼痛严重程度和残疾的临床测量、健康相关生活质量、心理社会幸福感和身体功能。将在基线、16周(干预后)和24周时评估结局。将进行定性访谈。
本研究结果将为单独或联合太极拳实际应用MCC治疗CNP的可行性和临床评估提供初步证据。这些数据将用于为一项评估两种有前景的CNP非药物疗法的全效析因试验的设计提供信息。
本研究已在ClinicalTrials.gov(NCT05726331)注册。