一种用于测试干针治疗中参与者和治疗师盲法的新型盲法方案：一项随机对照试验。
A novel blinding protocol to test participant and therapist blinding during dry needling: a randomised controlled experiment.
机构信息
IIMPACT in Health, University of South Australia, GPO Box 2471, Adelaide 5001, South Australia, Australia.
出版信息
Physiotherapy. 2021 Dec;113:188-198. doi: 10.1016/j.physio.2021.08.007. Epub 2021 Aug 25.
OBJECTIVES
Dry needling is widely used in physiotherapy. Lack of blinding in clinical trials means that dry needling effects and mechanisms remain unclear, with blinding issues accepted as an unavoidable barrier to better evidence. The authors aimed to overcome this barrier by designing a protocol to double-blind dry needling trials.
DESIGN
A prospectively registered randomised experiment tested a novel blinding protocol for blinding effectiveness.
SETTING
University physiotherapy clinic.
PARTICIPANTS
Therapists (n=15) and asymptomatic volunteers ('recipients') (n=45) were randomly allocated to real and/or sham interventions.
INTERVENTIONS
The protocol involved custom-made needles and cognitive and multisensory blinding techniques.
MAIN OUTCOME MEASURES
The primary outcome was guesses about allocation. The a priori criterion for successful blinding was ≤50% correct guesses (random chance). Secondary analyses explored blinding patterns using blinding indices.
RESULTS
Correct guesses were not different from 50% for therapists [41% (95%CI 30 to 50), n=120 guesses] or recipients [49% (95%CI 38 to 60), n=90 guesses]. Blinding indices supported the primary result but revealed that recipients were better at detecting real dry needling than sham.
CONCLUSION
Both therapists and recipients were successfully blinded, which contrasts with the widely held assumption that double-blinding is impossible for needling interventions. The authors recommend that any future trials can, and therefore should, blind therapists. However, secondary analyses revealed that recipients receiving real dry needling were less blinded than sham recipients, which may still create bias in clinical trials and suggests further work is needed to improve recipient blinding. Nonetheless, the current findings offer an opportunity to gain better evidence concerning the effects and mechanisms of dry needling.
STUDY REGISTRATION
目的
干针疗法在物理治疗中被广泛应用。临床试验中缺乏盲法意味着干针疗法的效果和机制仍不清楚，盲法问题被认为是获得更好证据的一个不可避免的障碍。作者旨在通过设计一项双盲干针试验方案来克服这一障碍。
设计
一项前瞻性注册的随机试验测试了一种新的盲法方案的盲法效果。
设置
大学物理治疗诊所。
参与者
治疗师（n=15）和无症状志愿者（“接受者”）（n=45）被随机分配到真实和/或模拟干预组。
干预
该方案涉及定制的针和认知及多感官盲法技术。
主要观察指标
主要结局是对分配的猜测。成功盲法的预先设定标准为≤50%的正确猜测（随机机会）。次要分析使用盲法指数探索盲法模式。
结果
治疗师的正确猜测与 50%无差异[41%（95%CI 30 至 50），n=120 次猜测]或接受者[49%（95%CI 38 至 60），n=90 次猜测]。盲法指数支持主要结果，但表明接受者检测真实干针的能力优于模拟干针。
结论
治疗师和接受者均成功被盲法，这与广泛认为的针刺干预不可能双盲的假设形成对比。作者建议，任何未来的试验都可以而且应该对治疗师进行盲法。然而，二次分析显示，接受真实干针的接受者比接受模拟干针的接受者的盲法程度更低，这可能仍然会给临床试验带来偏倚，并表明需要进一步工作来提高接受者的盲法。尽管如此，目前的研究结果为获得关于干针疗法效果和机制的更好证据提供了机会。
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