Acupuncture in subjects with cold hands sensation: study protocol for a
randomized controlled trial.
Author(s): Seo JC, Lee HJ, Kwak MA, Park SH, Shin I, Yun WS, Park K(1).
Affiliation(s): Author information:
(1)Division of Vascular Surgery, Department of sugery, School of Medicine,
Catholic University of Daegu, 3056-6 Daemyeong 4-dong, Nam-gu, Daegu 705-718,
Republic of Korea. khpark@cu.ac.kr.
Publication date & source: 2014, Trials. , 15:348
BACKGROUND: Cold hands sensation is a common disorder within the Korean
population. Many Korean family physicians believe that it is a mild early
manifestation of Raynaud's phenomenon (RP), or may be related to RP. RP is
characterized by reversible digital vasospasm provoked by cold temperatures
and/or emotional stress, and doctors often prescribe medications that are used in
treatment of RP for subjects with cold hands. However, this has not shown a clear
benefit, and these medications can cause unwanted side effects. It is also
reported that traditional Korean medicine, including acupuncture, is widely used
to treat cold hands, although the current level of evidence for this approach is
also poor and to date, there have been no published randomized controlled
clinical trials (RCTs) evaluating the efficacy and safety of acupuncture for cold
hands. We have therefore designed a pilot RCT to obtain information for the
design of a further full-scale trial.
METHODS/DESIGN: The proposed study is a five-week pilot RCT. A total of 14
subjects will be recruited and randomly allocated to two groups: an acupuncture
plus medication group (experimental group) and a medication-only group (control
group). All subjects will take nifedipine (5 mg once daily) and beraprost (20 mg
three times daily) for three weeks. The experimental group will receive
additional treatment with three acupuncture sessions per week for three weeks
(nine sessions total). The primary outcome will be measured using a visual
analogue scale. Secondary outcomes will be measured by blood perfusion in laser
Doppler perfusion imaging of the hands, frequency and duration of episodes of
cold hands, and heart rate variability. Assessments will be made at baseline and
at one, three, and five weeks thereafter.
DISCUSSION: This study will provide an indication of the feasibility and a
clinical foundation for a future large-scale trial.
TRIAL REGISTRATION: This study was registered at Korean Clinical Research
Information Service (CRIS) registry on 5 August 2013 with the registration number
#KCT0000817.
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