title: Acupuncture in subjects with cold hands sensation: study protocol for a randomized controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  This study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial.
  
  
  BACKGROUND
  This study was registered at Korean Clinical Research Information Service (CRIS) registry on 5 August 2013 with the registration number #KCT0000817.
authors.forename: Jung-Chul
authors.initials: JC
authors.lastname: Seo
authors.forename: Hyun-jong
authors.initials: HJ
authors.lastname: Lee
authors.forename: Min-Ah
authors.initials: MA
authors.lastname: Kwak
authors.forename: Sung-Hoon
authors.initials: SH
authors.lastname: Park
authors.forename: ImHee
authors.initials: I
authors.lastname: Shin
authors.forename: Woo-Sung
authors.initials: WS
authors.lastname: Yun
authors.affiliation: 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.
authors.forename: Kihyuk
authors.initials: K
authors.lastname: Park
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects; D001783:Blood Flow Velocity; D001833:Body Temperature Regulation / Q000187:drug effects; D002985:Clinical Protocols; D003080:Cold Temperature; D011464:Epoprostenol / Q000031:analogs & derivatives / Q000627:therapeutic use; D005240:Feasibility Studies; D006225:Hand / Q000098:blood supply* / Q000294:innervation*; D006339:Heart Rate; D006801:Humans; D017078:Laser-Doppler Flowmetry; D009543:Nifedipine / Q000627:therapeutic use; D016491:Peripheral Vascular Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010865:Pilot Projects; D012039:Regional Blood Flow; D056910:Republic of Korea; D012107:Research Design; D013697:Thermosensing / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D014661:Vasoconstriction; D014665:Vasodilator Agents / Q000627:therapeutic use
chemical_list: D014665:Vasodilator Agents; C048081:beraprost; D011464:Epoprostenol; D009543:Nifedipine