Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Hong Kong, China.
School of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong, China.
BMJ Open. 2024 Jul 5;14(7):e085856. doi: 10.1136/bmjopen-2024-085856.
Upper limb problems have a significant impact on the global population leading to pain and restricted joint mobility, ultimately impacting their quality of life. Traditional treatments, such as non-steroidal anti-inflammatory drugs and corticosteroids, often come with undesirable side effects, prompting patients to seek alternative therapies. In this trial, we hypothesise that soothing cream gel (SCG) will improve range of motion and chronic pain in the shoulder and elbow. The objective of this trial is to evaluate the efficacy of SCG in improving the range of motion and chronic pain in the shoulder and elbow.
A double-blinded, randomised, placebo-controlled trial is conducted to compare the effects of SCG and placebo gel. SCG contains essence, essential oil, etc, and is manufactured according to Good Manufacturing Practice standards. The placebo gel will be processed with similar appearance, texture and scent but will lack active ingredients. 70 participants with upper limb problems will be recruited from four study sites, including clinical centres and a sport department at the Chinese University of Hong Kong (CUHK). Participants will be randomly assigned to either treatment group or placebo group for 2 weeks. Primary outcome will be the range of motion in the upper limb, assessed by a goniometer, to measure active flexion and abduction for the shoulder, and active flexion and extension for the elbow. The primary efficacy analyses will be based on the full analysis set following the intention-to-treat principle.
The trial has obtained approval from the joint CUHK-New Territories East Cluster (CRE-2023.142), and the patient enrolment commenced in July 2023. Written informed consent will be obtained from all participants prior to participation. Study results will be disseminated through publication in peer-reviewed journals and presentations at conference.
NCT05799391.
上肢问题对全球人口有重大影响，导致疼痛和关节活动受限，最终影响他们的生活质量。传统的治疗方法，如非甾体抗炎药和皮质类固醇，往往伴随着不良的副作用，促使患者寻求替代疗法。在这项试验中，我们假设舒缓霜凝胶（SCG）将改善肩部和肘部的活动范围和慢性疼痛。本试验的目的是评估 SCG 改善肩部和肘部活动范围和慢性疼痛的疗效。
进行了一项双盲、随机、安慰剂对照试验，比较 SCG 和安慰剂凝胶的效果。SCG 含有精华、精油等，并按照良好生产规范标准制造。安慰剂凝胶将采用类似的外观、质地和气味进行加工，但缺乏有效成分。将从四个研究地点（包括香港中文大学的临床中心和体育部）招募 70 名上肢问题患者。参与者将随机分配到治疗组或安慰剂组，为期 2 周。主要结局将是通过量角器评估上肢的活动范围，以测量肩部的主动屈曲和外展以及肘部的主动屈曲和伸展。主要疗效分析将基于意向治疗原则的全分析集进行。
该试验已获得香港中文大学-新界东联网（CRE-2023.142）的批准，患者招募已于 2023 年 7 月开始。在参与之前，将从所有参与者那里获得书面知情同意。研究结果将通过发表在同行评议期刊和会议上的论文传播。
NCT05799391。
