The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Change in pain pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention.
研究概览
简要总结
Placebo responses are now recognized for their clinical and physiological significance. Non-pharmacological cues such as sound may enhance or induce these responses. This trial aims to assess the effect of sound on the placebo-induced hypoalgesia elicited by a deactivated TENS device in healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and assessor blinded
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of TENS use
排除标准
- •Current medication use
- •Orthopedic, neurological, or systemic conditions
- •Pregnancy (current and planned)
研究组 & 干预措施
Group A: Placebo with sound
Deactivated transcutaneous electrical nerve stimulation (TENS) with beeping sound (15-second interval)
干预措施: Group A Deactivated TENS with beeping sound (15-second interval) (Procedure)
Group B: Placebo with no sound
Group B: Deactivated transcutaneous electrical nerve stimulation (TENS) without sound
干预措施: Group B (Procedure)
结局指标
主要结局
Change in pain pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention.
时间窗: From Baseliine to 5 minutes
Change in pain pressure threshold (PPT) at L2 (2nd lumbar vertebra) from baseline to post-intervention. Measured using pressure algometer (Wagner Force Dial FDK/FDN Series).
次要结局
- Effect of gender on placebo response(From Baseliine to 5 minutes)