在参与者和结果评估者之间盲目的脊髓手动治疗干预措施的可行性:盲目的可行性试验协议
Javier Muñoz Laguna1,2,3, Astrid Kurmann1, Léonie Hofstetter1
1EBPI-UWZH Musculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University Hospital, Zurich, Switzerland.
Pilot and feasibility studies
|May 2, 2024
概括
这项研究评估了盲目的参与者和结果评估人员在脊椎手动治疗背痛的试验中的可行性. 这些发现将为未来的脊柱干预盲目的方法的研究提供信息.
科学领域:
- 临床试验方法论 临床试验方法论
- 疼痛管理研究 疼痛管理研究
- 脊柱干预手术 脊柱干预手术
背景情况:
- 失明在随机对照试验中至关重要,但在背部疼痛的脊柱手动治疗研究中经常被忽视.
- 对于未来的试验,需要有效的失明方法来比较脊柱手动治疗和神经根注射,以治疗 lumbosacral 根部疼痛.
研究的目的:
- 评估盲目的参与者对活跃或安慰剂脊柱手动治疗的可行性.
- 评估盲目的结果评估者的可行性.
- 探索影响失明的因素,包括先前的经验和疼痛水平.
主要方法:
- 一个安慰剂控制的,方法盲目的随机可行性试验,涉及60-100名成年人.
- 参与者被随机分配到两个访问的活跃或安慰剂脊柱手动治疗中.
- 主要结果:参与者盲目化使用Bang盲目化指数;次要结果:詹姆斯盲目化指数,评估者盲目化,可信度,预期和其他患者报告的结果.
主要成果:
- 参与者和结果评估者蒙蔽的可行性将使用已建立的蒙蔽指数来确定.
- 探索影响对干预指派感知的因素.
- 将收集关于可信度,预期时间和其他患者报告的结果的数据.
结论:
- 这项研究将提供关键的数据,关于在脊柱手动治疗试验中盲目的可行性.
- 结果将直接告知未来双安慰剂对照试验 (SALuBRITY) 的设计,用于 lumbosacral 根性疼痛.
- 改进的遮方法将提高未来脊柱干预研究的方法严格性.
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