Acupuncture in subjects with cold hands sensation: study protocol for a randomized controlled trial

Area of Science:

• Integrative and Complementary Medicine
• Clinical Trial Design

Background:

• Cold hands sensation is prevalent in Korea, often presumed related to Raynaud's phenomenon (RP).
• Current treatments for cold hands, including RP medications and traditional Korean medicine, lack robust evidence and can cause side effects.
• No randomized controlled trials (RCTs) have evaluated acupuncture's efficacy for cold hands.

Purpose of the Study:

• To conduct a pilot randomized controlled trial (RCT) assessing acupuncture's feasibility and efficacy for cold hands.
• To gather data for designing a future large-scale clinical trial on acupuncture for cold hands.

Main Methods:

• A five-week pilot RCT involving 14 subjects randomly assigned to an acupuncture plus medication group or a medication-only control group.
• Both groups received nifedipine and beraprost; the experimental group received three acupuncture sessions weekly for three weeks.
• Outcomes measured included visual analogue scale, laser Doppler perfusion imaging, cold hands episode frequency/duration, and heart rate variability at multiple time points.

Main Results:

• This section is not applicable as the abstract describes a pilot study design and does not present results.

Conclusions:

• This pilot RCT aims to establish feasibility and provide a clinical foundation for a larger trial on acupuncture for cold hands.
• The study will inform the design of future research investigating the effectiveness of acupuncture in managing cold hands sensation.