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Evaluating validity of various acupuncture device types: a random sequence clinical trial
Jungtae Leem1,2, Jimin Park3, Gajin Han1,4
1Korean Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
BMC Complementary and Alternative Medicine
|February 3, 2016
Summary
This study validates placebo acupuncture devices for use in clinical trials. It assesses whether these devices effectively serve as placebos in control groups, ensuring research integrity.
Area of Science:
- Acupuncture Research
- Clinical Trial Design
- Placebo Validation
Background:
- Controversy exists regarding the efficacy of placebo acupuncture devices as controls in research.
- Existing placebo devices may not accurately represent true placebos for acupuncture studies.
Purpose of the Study:
- To evaluate the validity of placebo acupuncture devices as controls in clinical trials.
- To assess the appropriateness of current placebo acupuncture devices through a validation test procedure.
Main Methods:
- A single-center, prospective, randomized, participant- and assessor-blinded trial.
- 76 participants allocated 1:1 to two groups, receiving different combinations of real, sham, and phantom acupuncture sessions.
- Primary endpoint: Blinding test questionnaire; Secondary endpoints: Blinding index, sensation scale, and physiological measures.
Main Results:
- N/A - Study results are not yet available in the abstract.
Conclusions:
- This trial aims to determine the relevance of using placebo acupuncture devices as controls.
- Findings will inform the appropriate use of placebo devices in acupuncture research.
