Postgraduate Program in Rehabilitation Sciences, Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN/FACISA), Santa Cruz, Brazil.
Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte (UFRN/FACISA), Santa Cruz, Brazil.
BMJ Open. 2020 Dec 24;10(12):e039857. doi: 10.1136/bmjopen-2020-039857.
Knee osteoarthritis (KOA) is the most common cause of pain and disability worldwide. Dry cupping has been used as non-pharmacological approach to control pain and improve physical function. However, there is a lack of high-quality scientific evidence regarding its effects on this condition. This protocol describes a sham-controlled, randomised and simple blind study that aims to evaluate the effect of dry cupping on pain, function and quality of life in women with KOA.
Sixty-two women diagnosed with KOA, based on American College of Rheumatology clinical criteria, and aged from 50 to 75 years, will be randomly distributed into two groups (31 per group): real and sham dry cupping. Both applications will occur with acrylic cups around the knee. The intervention will last 15 min, two times a week over six consecutive weeks, for a total of 12 sessions. Both groups will be assessed at four different times: before the intervention (T0), after 3 weeks intervention (T3), at the end of the protocol (T6) and 4 weeks after the interventions (follow-up: T10). The primary outcome will be pain intensity (Numerical Pain Rating Scale), and secondary outcomes will be knee-related health status (Western Ontario and McMaster Universities Osteoarthritis Index), functional capacity (8-step stair climb test, 40-metre fast-paced walk test and 30-second chair stand test), quality of life (Short-Form 36) and global perceived effect.
This protocol was approved by the UFRN/FACISA Ethics Committee (number 3.737.688). The study results will be disseminated to the participants and submitted to a peer-reviewed journal and scientific meetings.
NCT04331158.
膝骨关节炎（KOA）是全球最常见的疼痛和残疾原因。拔罐已被用作控制疼痛和改善身体功能的非药物方法。然而，关于其对这种疾病的影响，缺乏高质量的科学证据。本方案描述了一项假对照、随机和简单盲法研究，旨在评估拔罐对 KOA 女性疼痛、功能和生活质量的影响。
根据美国风湿病学会临床标准诊断为 KOA 的 62 名年龄在 50 至 75 岁之间的女性将被随机分为两组（每组 31 名）：真实拔罐和假拔罐。两种应用均采用膝周丙烯酸杯进行。干预将持续 15 分钟，每周两次，连续 6 周，共 12 次。两组均在四个不同时间点进行评估：干预前（T0）、干预 3 周后（T3）、方案结束时（T6）和干预后 4 周（随访：T10）。主要结局指标为疼痛强度（数字疼痛评分量表），次要结局指标为膝关节相关健康状况（西安大略和麦克马斯特大学骨关节炎指数）、功能能力（8 步爬楼梯测试、40 米快走测试和 30 秒坐立测试）、生活质量（简短表格 36）和整体感知效果。
本方案已获得 UFRN/FACISA 伦理委员会的批准（编号 3.737.688）。研究结果将向参与者公布，并提交给同行评议期刊和科学会议。
NCT04331158。
