Abstract
BackgroundCold 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/DesignThe 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.DiscussionThis study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial.Trial registrationThis study was registered at Korean Clinical Research Information Service (CRIS) registry on 5 August 2013 with the registration number #KCT0000817.
Highlights
Cold hands sensation is a common disorder within the Korean population
In Korea, many physicians believe the phenomenon is related to Raynaud’s phenomenon (RP), and they may prescribe pharmaceutical treatments similar to those used for patients with RP [5,8]
There is no established guideline for RP therapy, and many of the agents most frequently used in the treatment of RP are used off-label [15] and consist mainly of vasodilators, in particular calcium channel antagonists such as nifedipine
Summary
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 This has not shown a clear benefit, and these medications can cause unwanted side effects. Reactions characterized by excessive peripheral vasospasm may evoke clinical symptoms, sensitivity to cold temperatures in their fingertips or toes [3,4] This may be due to a mild, early manifestation of Raynaud’s phenomenon (RP) or may be related to RP [1,5], which is characterized by a reversible digital vasospasm provoked by cold temperatures and/or emotional stress [6]. There is currently no gold standard or universal guideline for the treatment of RP [6,15]
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