Abstract：
OBJECTIVE: Frozen shoulder is a prevalent condition among individuals in their middle and later years. Invasive therapy has shown promising results in the treatment of frozen shoulders, but its widespread adoption has been hampered by high costs and the need for advanced medical technology. As a result, patients with frozen shoulders often turn to non-steroidal anti-inflammatory drugs (NSAIDs) for symptomatic relief. However, the oral administration of NSAIDs can lead to troublesome adverse effects on the gastrointestinal, cardiovascular, and urinary systems. In contrast, topical NSAIDs have gained attention for their excellent efficacy and lower adverse effects in various chronic pain conditions. Therefore, our study aimed to investigate the efficacy and safety of topical NSAIDs in improving pain and mobility among patients with frozen shoulders.
METHODS: A total of 108 patients experiencing moderate to severe pain and mobility impairment due to frozen shoulder were enrolled in this study. The participants were randomly assigned to either the experimental group (n=72) or the control group (n=36). The experimental group received daily treatment with the loxoprofen hydrogel patch (LOX-P) in addition to basic rehabilitation physiotherapy. The control group was treated with flurbiprofen cataplasm (FLU-C) twice a day, along with rehabilitation physiotherapy. The primary endpoint for evaluating the efficacy of the two patches was the Constant-Murley score (CMS). Clinical symptom data, adverse events, and patient satisfaction were also recorded.
RESULTS: After 14 days of treatment, the effective rate was 66.67% (n=48) in the experimental group and 41.67% (n=15) in the control group. The overall difference in the effective rates was 25.00% (95% CI=5.20-42.52; p=0.013). The safety profiles of the two topical agents were similar, with only a few adverse events reported.
CONCLUSIONS: The loxoprofen hydrogel patch demonstrates a significant ability to alleviate shoulder pain and restore shoulder function in the treatment of frozen shoulder, with minimal adverse reactions. Chictr.org.cn ID: ChiCTR2100052375.
METHODS: A total of 108 patients experiencing moderate to severe pain and mobility impairment due to frozen shoulder were enrolled in this study. The participants were randomly assigned to either the experimental group (n=72) or the control group (n=36). The experimental group received daily treatment with the loxoprofen hydrogel patch (LOX-P) in addition to basic rehabilitation physiotherapy. The control group was treated with flurbiprofen cataplasm (FLU-C) twice a day, along with rehabilitation physiotherapy. The primary endpoint for evaluating the efficacy of the two patches was the Constant-Murley score (CMS). Clinical symptom data, adverse events, and patient satisfaction were also recorded.
RESULTS: After 14 days of treatment, the effective rate was 66.67% (n=48) in the experimental group and 41.67% (n=15) in the control group. The overall difference in the effective rates was 25.00% (95% CI=5.20-42.52; p=0.013). The safety profiles of the two topical agents were similar, with only a few adverse events reported.
CONCLUSIONS: The loxoprofen hydrogel patch demonstrates a significant ability to alleviate shoulder pain and restore shoulder function in the treatment of frozen shoulder, with minimal adverse reactions. Chictr.org.cn ID: ChiCTR2100052375.
摘要：
目的：肩周炎是中后期个体中普遍存在的疾病。侵入性治疗在冻结肩的治疗中显示出有希望的结果，但是由于成本高昂和对先进医疗技术的需求，它的广泛采用受到了阻碍。因此,肩周炎患者通常求助于非甾体类抗炎药(NSAIDs)以缓解症状.然而,NSAIDs的口服给药会对胃肠道产生不利影响，心血管,和泌尿系统。相比之下,局部NSAIDs因其在各种慢性疼痛中的优异疗效和较低的不良反应而受到关注.因此,我们的研究旨在探讨外用NSAIDs改善肩周炎患者疼痛和活动能力的有效性和安全性.
方法：本研究共纳入108例因肩周炎而出现中度至重度疼痛和活动障碍的患者。参与者被随机分配到实验组（n=72）或对照组（n=36）。实验组除接受基础康复理疗外，每天接受洛索洛芬水凝胶贴片（LOX-P）治疗。对照组给予氟比洛芬巴布剂(FLU-C),每日2次,以及康复理疗。评估两种贴剂疗效的主要终点是Constant-Murley评分（CMS）。临床症状数据，不良事件,并记录患者满意度.
结果：治疗14天后，实验组有效率为66.67%(n=48),对照组有效率为41.67%(n=15)。总有效率差异为25.00%(95%CI=5.20-42.52;p=0.013)。两种外用药物的安全性相似，仅报告了一些不良事件。
结论：洛索洛芬水凝胶贴剂在治疗冻结肩方面表现出明显的减轻肩痛和恢复肩关节功能的能力，不良反应最小。Chictr.org.cnID:ChiCTR2100052375。
方法：本研究共纳入108例因肩周炎而出现中度至重度疼痛和活动障碍的患者。参与者被随机分配到实验组（n=72）或对照组（n=36）。实验组除接受基础康复理疗外，每天接受洛索洛芬水凝胶贴片（LOX-P）治疗。对照组给予氟比洛芬巴布剂(FLU-C),每日2次,以及康复理疗。评估两种贴剂疗效的主要终点是Constant-Murley评分（CMS）。临床症状数据，不良事件,并记录患者满意度.
结果：治疗14天后，实验组有效率为66.67%(n=48),对照组有效率为41.67%(n=15)。总有效率差异为25.00%(95%CI=5.20-42.52;p=0.013)。两种外用药物的安全性相似，仅报告了一些不良事件。
结论：洛索洛芬水凝胶贴剂在治疗冻结肩方面表现出明显的减轻肩痛和恢复肩关节功能的能力，不良反应最小。Chictr.org.cnID:ChiCTR2100052375。
