Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095#, Jiefang Avenue, Wuhan, 430030, Hubei, China.
Basic science department, Faculty of Physical Therapy, Beni-Suef University, Beni-Suef, Egypt.
Trials. 2019 Apr 29;20(1):248. doi: 10.1186/s13063-019-3337-0.
Nonspecific neck pain (NSNP) is one of the most common musculoskeletal problems treated by orthopaedic physicians and physiotherapists. Posture has emerged as one of the major risk factors associated with NSNP, but most previous studies ignored correct posturing as an effective treatment. Therefore, one of the major challenges faced by clinicians is how to incorporate 3D posture findings into the treatment plane. The present study will evaluate the feasibility of conducting a larger randomized trial. This pilot study is designed to investigate the hypothesis that a multimodal programme supplemented with the addition of a 3D adjustable cervico thoracic posture corrective orthotic (CTPCO) will yield short- and long-term improvement on NSNP management outcomes.
METHODS/DESIGN: This pilot, single-blind, randomized controlled trial will divide 24 patients into two groups (study and control) using block randomization. Both groups will receive conventional treatment consisting of a moist hot pack, soft tissue mobilization, manual therapy and therapeutic exercise. The study group will undergo ambulatory mirror-image functional re-training wearing a 3D adjustable CTPCO. The primary outcome is feasibility, including recruitment (e.g., time to complete enrolment, recruitment rate), patient retention and adherence to treatment allocation (e.g., session attendance, home practice, use of non-study treatments). The secondary outcomes used to assess the effectiveness of the treatment will include neck pain (measures using the visual analogue scale (VAS)) and neck disability (measures using the neck disability index (NDI)), among other outcome measures, compared between the experimental and control groups. Three-dimensional posture parameters of head measurements will be provided by a Global Posture System (GPS). The outcome measures for determining the treatment effect will be assessed at three intervals: pre-treatment, after 10 weeks of intervention and after 3 months at follow-up.
This randomized controlled pilot trial will inform the design of a future full-scale trial. The outcomes will provide some resources for the incorporation of ambulatory mirror-image functional re-training intervention compared to a control group intervention for neck pain, disability and 3D posture parameters.
Prospectively registered at ClinicalTrials.gov, NCT03331120 . Registered on 22 October 2017.
非特异性颈部疼痛（NSNP）是矫形医师和物理治疗师治疗的最常见肌肉骨骼问题之一。姿势已成为与 NSNP 相关的主要危险因素之一，但大多数先前的研究忽略了正确姿势作为一种有效治疗方法。因此，临床医生面临的主要挑战之一是如何将 3D 姿势发现纳入治疗平面。本研究将评估进行更大规模随机试验的可行性。这项初步研究旨在检验以下假设：补充多模式方案并增加 3D 可调节颈胸姿势矫正矫形器（CTPCO）将在 NSNP 管理结果方面产生短期和长期改善。
方法/设计：这项初步的、单盲、随机对照试验将使用区组随机化将 24 名患者分为两组（研究组和对照组）。两组均接受常规治疗，包括湿热敷、软组织松解、手法治疗和运动治疗。研究组将在佩戴 3D 可调节 CTPCO 的情况下进行可移动镜像功能再训练。主要结局是可行性，包括招募（例如，完成招募的时间、招募率）、患者保留和对治疗分配的依从性（例如，就诊次数、家庭练习、使用非研究治疗）。用于评估治疗效果的次要结局包括颈部疼痛（使用视觉模拟量表（VAS）测量）和颈部残疾（使用颈部残疾指数（NDI）测量），以及其他结局测量，比较实验组和对照组。头部测量的三维姿势参数将由全球姿势系统（GPS）提供。确定治疗效果的测量结果将在三个时间点进行评估：治疗前、干预 10 周后和 3 个月随访时。
这项随机对照初步试验将为未来的全面试验设计提供信息。结果将为颈痛、残疾和 3D 姿势参数的可移动镜像功能再训练干预与对照组干预的结合提供一些资源。
前瞻性在 ClinicalTrials.gov 注册，NCT03331120。于 2017 年 10 月 22 日注册。
