PDF(Pubmed)
Abstract：
BACKGROUND: Fu\'s subcutaneous needling (FSN) is a new type of acupuncture that uses subcutaneous tissue to oscillate from side to side to improve muscle pathology status and can be effective in treating Knee osteoarthritis. Nonetheless, whether the clinical effect is similar to that of most commonly used drugs is unclear. Thus, this study aims to determine the pain-relieving effect and improvement in the joint function of the FSN therapy by comparing it with that of a positive control drug (celecoxib). Furthermore, this clinical trial also aims to evaluate the effect of FSN on gait and lower limb muscle flexibility, which can further explore the scientific mechanisms of the FSN therapy.
METHODS: This study is a randomized, parallel-controlled, single-center prospective clinical study that includes 60 participants, with an FSN group (n = 30) and a drug group (n = 30). The Fu\'s subcutaneous needling (FSN) group undergo the FSN therapy 3 times a week for 2 weeks, while the drug group receives 0.2 g/day oral celecoxib for 2 weeks, with a follow-up period of 4 weeks after the completion of treatment. The primary outcome is the difference in the visual analog scale score after 2 weeks of treatment compared with baseline. The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, joint active range of motion test, three-dimensional gait analysis, and shear wave elastic imaging technology analysis in lower limb muscles are also performed to demonstrate clinical efficacy.
BACKGROUND: The trial is performed following the Declaration of Helsinki. The study protocol and consent form have been approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine. All patients will give informed consent before participation and the trial is initiated after approval. The results of this trial will be disseminated through publication in peer-reviewed journals.
BACKGROUND: NCT06328153.
METHODS: This study is a randomized, parallel-controlled, single-center prospective clinical study that includes 60 participants, with an FSN group (n = 30) and a drug group (n = 30). The Fu\'s subcutaneous needling (FSN) group undergo the FSN therapy 3 times a week for 2 weeks, while the drug group receives 0.2 g/day oral celecoxib for 2 weeks, with a follow-up period of 4 weeks after the completion of treatment. The primary outcome is the difference in the visual analog scale score after 2 weeks of treatment compared with baseline. The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, joint active range of motion test, three-dimensional gait analysis, and shear wave elastic imaging technology analysis in lower limb muscles are also performed to demonstrate clinical efficacy.
BACKGROUND: The trial is performed following the Declaration of Helsinki. The study protocol and consent form have been approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine. All patients will give informed consent before participation and the trial is initiated after approval. The results of this trial will be disseminated through publication in peer-reviewed journals.
BACKGROUND: NCT06328153.
摘要：
背景：傅氏皮下针刺法（FSN）是一种新型的针刺疗法，利用皮下组织左右振荡改善肌肉病理状态，可有效治疗膝骨性关节炎。尽管如此，临床效果是否与大多数常用药物相似尚不清楚。因此，本研究旨在通过与阳性对照药物(塞来昔布)比较,确定FSN治疗的疼痛缓解效果和关节功能改善.此外，该临床试验还旨在评估FSN对步态和下肢肌肉灵活性的影响，这可以进一步探索FSN治疗的科学机制。
方法：这项研究是一项随机的，并行控制，单中心前瞻性临床研究，包括60名参与者，FSN组（n=30）和药物组（n=30）。Fu's皮下针刺(FSN)组每周3次,连续2周,而药物组接受0.2克/天口服塞来昔布，持续2周，治疗结束后随访4周。主要结果是治疗2周后视觉模拟量表评分与基线相比的差异。西安大略省和麦克马斯特大学（WOMAC）骨关节炎指数，关节活动范围测试，三维步态分析,并对下肢肌肉进行了剪切波弹性成像技术分析，以证明临床疗效。
背景：该试验是在赫尔辛基宣言之后进行的。研究方案和同意书已经广东省中医院伦理委员会批准。所有患者在参与前都将获得知情同意，并在批准后开始试验。该试验的结果将通过发表在同行评审的期刊上进行传播。
背景：NCT06328153。
方法：这项研究是一项随机的，并行控制，单中心前瞻性临床研究，包括60名参与者，FSN组（n=30）和药物组（n=30）。Fu's皮下针刺(FSN)组每周3次,连续2周,而药物组接受0.2克/天口服塞来昔布，持续2周，治疗结束后随访4周。主要结果是治疗2周后视觉模拟量表评分与基线相比的差异。西安大略省和麦克马斯特大学（WOMAC）骨关节炎指数，关节活动范围测试，三维步态分析,并对下肢肌肉进行了剪切波弹性成像技术分析，以证明临床疗效。
背景：该试验是在赫尔辛基宣言之后进行的。研究方案和同意书已经广东省中医院伦理委员会批准。所有患者在参与前都将获得知情同意，并在批准后开始试验。该试验的结果将通过发表在同行评审的期刊上进行传播。
背景：NCT06328153。
