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The effectiveness of battlefield acupuncture in addition to standard physical therapy treatment after shoulder surgery: a protocol for a randomized clinical trial

机译:战场针灸的有效性除了肩部手术后的标准物理治疗方法:随机临床试验的议定书

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There is a large incidence of shoulder instability among active young athletes and military personnel. Shoulder stabilization surgery is the commonly employed intervention for treating individuals with instability. Following surgery, a substantial proportion of individuals experience acute post-operative pain, which is usually managed with opioid pain medications. Unfortunately, the extended use of opioid medications can have adverse effects that impair function and reduce military operational readiness, but there are currently few alternatives. However, battlefield acupuncture (BFA) is a minimally invasive therapy demonstrating promise as a non-pharmaceutical intervention for managing acute post-operative pain. This is a parallel, two-arm, single-blind randomized clinical trial. The two independent variables are intervention (2 levels, standard physical therapy and standard physical therapy plus battlefield acupuncture) and time (5 levels, 24?h, 48?h, 72?h, 1?week, and 4?weeks post shoulder stabilization surgery). The primary dependent variables are worst and average pain as measured on the visual analog scale. Secondary outcomes include medication usage, Profile of Mood States, and Global Rating of Change. The magnitude of the effect of BFA is uncertain; current studies report confidence intervals of between-group differences that include minimal clinically important differences between intervention and control groups. The results of this study may help determine if BFA is an effective adjunct to physical therapy in reducing pain and opioid usage in acute pain conditions. ClinicalTrials.gov NCT04094246 . Registered on 16 September 2019.
机译:积极的年轻运动员和军事人员之间存在大的肩部不稳定发生率。肩部稳定手术是常用的干预治疗个体的不稳定。手术后,大量的个体患者术后疼痛经历,这通常与阿片类药物止痛药进行管理。不幸的是,阿片类药物的扩展使用可能具有损害功能和降低军事操作准备的不利影响,但目前有几个替代方案。然而,战场针灸(BFA)是一种微创的治疗,证明了管理急性术后疼痛的非药剂干预。这是一个平行,双臂,单盲随机临床试验。两个独立的变量是干预(2级,标准物理治疗和标准物理治疗加战场针灸)和时间(5级,24个,48个?H,72?H,1?周和4?周后肩部稳定外科手术)。主要依赖变量是在视觉模拟规模上测量的最差和平均疼痛。二次结果包括药物用法,情绪状态,以及变革的全球评级。 BFA效果的大小不确定;目前的研究报告了组间差异之间的置信区间,包括干预和对照组之间的临床上重要差异。本研究的结果可能有助于确定BFA是否是在减少急性疼痛条件下减少疼痛和阿片类药物的物理治疗的有效辅助。 ClinicalTrials.gov NCT04094246。 2019年9月16日注册。

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