Chen Lin, Zhang Qi, Huang Zheng, Da Weiwei, Liu Shuang, Xue Chunchun, Ding Chao, Chen Deta, Fan Tianyou, Shi Qi, Li Xiaofeng
Department of Orthopedics, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Department of Traditional Chinese Medicine, Xuhui District Tianping Street Community Health Center, Shanghai, People's Republic of China.
J Pain Res. 2023 Sep 13;16:3119-3131. doi: 10.2147/JPR.S424812. eCollection 2023.
Non-specific chronic neck pain (NSCNP) is an increasingly common musculoskeletal disease and an important issue in the global healthcare system. Some studies have shown that the combination of manual therapy and exercise is effective in treating NSCNP but still with several limitations. Traditional Chinese manual therapy (tuina) is a Chinese manual therapy that consists of soft tissue manipulation and spinal manipulation. This study aims to design a randomized controlled trial to assess the effect of a tuina combined with specific therapeutic neck exercise modified protocol for NSCNP patients.
This is a study protocol for a randomized, participant-, assessor- and analyst-blinded controlled trial. Eighty-eight eligible NSCNP patients will be randomly allocated into tuina combined with specific therapeutic neck exercise group (TSTE group) and tuina combined with sham therapeutic neck exercise group (TS group) in a ratio of 1:1. All participants will receive 8 treatment sessions applied in 4 weeks and then be followed up for another 12 weeks. Clinical data will be collected at baseline, during treatment phase (at the 2- and 4-week) and at the 8-, 12-, 16-week follow-ups. The primary outcome is the changes in neck pain intensity (visual analogue scale). The secondary outcomes include neck disability (Neck Disability Index), cervical range of motion (ROM), neck muscle endurance, cervical muscle cross-sectional area, cervical curvature and analgesic consumption. Adverse events will be collected and recorded throughout the study.
We will discuss whether our tuina combined with specific therapeutic neck exercise modified protocol is more effective at improving pericervical muscle endurance, ROM, cervical muscle cross-sectional area and cervical curvature than tuina alone, thereby decreases neck pain and disability in individuals with NSCNP more effectively.
Chinese Clinical Trials Registry, ChiCTR2300067903. Registered on 31 January 2023.
非特异性慢性颈痛(NSCNP)是一种日益常见的肌肉骨骼疾病,也是全球医疗保健系统中的一个重要问题。一些研究表明,手法治疗与运动相结合对NSCNP的治疗有效,但仍存在一些局限性。中医手法治疗(推拿)是一种包括软组织手法和脊柱手法的中医手法治疗。本研究旨在设计一项随机对照试验,以评估推拿结合特定治疗性颈部运动改良方案对NSCNP患者的疗效。
这是一项随机、参与者、评估者和分析者双盲对照试验的研究方案。88例符合条件的NSCNP患者将按1:1的比例随机分为推拿结合特定治疗性颈部运动组(TSTE组)和推拿结合假治疗性颈部运动组(TS组)。所有参与者将在4周内接受8次治疗,然后再随访12周。临床数据将在基线、治疗阶段(第2周和第4周)以及第8、12、16周随访时收集。主要结局是颈部疼痛强度的变化(视觉模拟量表)。次要结局包括颈部功能障碍(颈部功能障碍指数)、颈椎活动范围(ROM)、颈部肌肉耐力、颈部肌肉横截面积、颈椎曲度和镇痛药消耗量。在整个研究过程中收集并记录不良事件。
我们将探讨我们的推拿结合特定治疗性颈部运动改良方案在改善颈周肌肉耐力、ROM、颈部肌肉横截面积和颈椎曲度方面是否比单纯推拿更有效,从而更有效地减轻NSCNP患者的颈部疼痛和功能障碍。
中国临床试验注册中心,ChiCTR2300067903。于2023年1月31日注册。