Youssef Ahmed S A, Moustafa Ibrahim M, El Melhat Ahmed M, Huang Xiaolin, Oakley Paul A, Harrison Deed E
Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095#, Jiefang Avenue, Wuhan 430030, China.
Basic Science Department, Faculty of Physical Therapy, Beni-Suef University, Beni-Suef 62521, Egypt.
J Clin Med. 2022 Nov 28;11(23):7028. doi: 10.3390/jcm11237028.
The aim of this study was to investigate the feasibility and effect of a multimodal program for the management of chronic nonspecific neck pain CNSNP with the addition of a 3D adjustable posture corrective orthotic (PCO), with a focus on patient recruitment and retention. This report describes a prospective, randomized controlled pilot study with twenty-four participants with CNSNP and definite 3D postural deviations who were randomly assigned to control and study groups. Both groups received the same multimodal program; additionally, the study group received a 3D PCO to perform mirror image® therapy for 20−30 min while the patient was walking on a treadmill 2−3 times per week for 10 weeks. Primary outcomes included feasibility, recruitment, adherence, safety, and sample size calculation. Secondary outcomes included neck pain intensity by numeric pain rating scale (NPRS), neck disability index (NDI), active cervical ROM, and 3D posture parameters of the head in relation to the thoracic region. Measures were assessed at baseline and after 10 weeks of intervention. Overall, 54 participants were screened for eligibility, and 24 (100%) were enrolled for study participation. Three participants (12.5%) were lost to reassessment before finishing 10 weeks of treatment. The between-group mean differences in change scores indicated greater improvements in the study group receiving the new PCO intervention. Using an effect size of 0.797, α > 0.05, β = 80% between-group improvements for NDI identified that 42 participants were required for a full-scale RCT. This pilot study demonstrated the feasibility of recruitment, compliance, and safety for the treatment of CNSNP using a 3D PCO to a multimodal program to positively affect CNSNP management.
本研究的目的是探讨一种多模式方案在慢性非特异性颈部疼痛（CNSNP）管理中的可行性和效果，该方案增加了一种3D可调节姿势矫正矫形器（PCO），重点关注患者的招募和留存。本报告描述了一项前瞻性、随机对照试验性研究，24名患有CNSNP且存在明确3D姿势偏差的参与者被随机分配到对照组和研究组。两组均接受相同的多模式方案；此外，研究组接受3D PCO，在患者每周2至3次在跑步机上行走时进行镜像®治疗20 - 30分钟，持续10周。主要结局包括可行性、招募、依从性、安全性和样本量计算。次要结局包括通过数字疼痛评分量表（NPRS）评估的颈部疼痛强度、颈部残疾指数（NDI）、颈椎活动度（ROM）以及头部相对于胸部区域的3D姿势参数。在基线和干预10周后对各项指标进行评估。总体而言，筛选了54名参与者以确定其是否符合资格，24名（100%）被纳入研究。3名参与者（12.5%）在完成10周治疗前失访。组间变化分数的平均差异表明，接受新PCO干预的研究组有更大改善。使用效应量0.797，α > 0.05，β = 80%的组间NDI改善情况确定，一项全面的随机对照试验需要42名参与者。这项试验性研究证明了使用3D PCO结合多模式方案治疗CNSNP在招募、依从性和安全性方面的可行性，对CNSNP管理产生了积极影响。
