title: Randomized controlled trial of the efficacy and safety of self-adhesive low-level light therapy in women with primary dysmenorrhea.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of low-level light therapy in women with primary dysmenorrhea.
  
  
  METHODS
  A multicenter prospective, randomized, double-blind, placebo-controlled clinical trial including patients 18-35 years of age with primary dysmenorrhea was undertaken at two university hospitals in South Korea between October 2011 and September 2012. Patients were randomized using a computer-generated sequence to receive low-level light therapy using the Color DNA-WSF device or to receive placebo treatment with a dummy device. The severity of menstrual pain, assessed using a visual analog scale, was the primary outcome and was evaluated at baseline and during every menstrual cycle for 3 months following treatment. Patients who received more than one application of treatment (with a Color DNA-WSF or placebo device) were included in analyses. Patients and investigators were masked to the treatment assignments.
  
  
  RESULTS
  Overall, 44 patients were assigned to each group. At the final study visit, the reduction in scores using a visual analog scale was significantly greater in patients who received low-level light therapy (n=41; 4.34±2.22) than among those in the control group (n=38; 1.79±1.73; P<0.001 when adjusted for age) No serious adverse events occurred.
  
  
  CONCLUSIONS
  Low-level light therapy could be an effective, safe treatment modality for women with primary dysmenorrhea. Clinical Trials.gov: NCT02026206.
authors.affiliation: Department of Obstetrics and Gynecology, Wonkwang University School of Medicine and Wonkwang University Hospital, Iksan, South Korea.
authors.forename: Gi-Youn
authors.initials: GY
authors.lastname: Hong
authors.affiliation: Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Byung-Cheul
authors.initials: BC
authors.lastname: Shin
authors.affiliation: Department of Obstetrics and Gynecology, Wonkwang University School of Medicine and Wonkwang University Hospital, Iksan, South Korea.
authors.forename: Seong-Nam
authors.initials: SN
authors.lastname: Park
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Yun-Hee
authors.initials: YH
authors.lastname: Gu
authors.affiliation: Medical Research Center, Color Seven, Seoul, South Korea.
authors.forename: Nam-Gyun
authors.initials: NG
authors.lastname: Kim
authors.affiliation: Medical Research Center, Color Seven, Seoul, South Korea.
authors.forename: Kyoung-Jun
authors.initials: KJ
authors.lastname: Park
authors.affiliation: Department of Rehabilitation Medicine, Pusan National University School of Medicine, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, South Korea.
authors.forename: Soo-Yeon
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Department of Rehabilitation Medicine, Pusan National University School of Medicine, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, South Korea. Electronic address: rmshin01@gmail.com.
authors.forename: Yong-Il
authors.initials: YI
authors.lastname: Shin
mesh_terms: D000268:Adhesiveness; D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004412:Dysmenorrhea / Q000532:radiotherapy*; D005260:Female; D006785:Hospitals, University; D006801:Humans; D028022:Low-Level Light Therapy / Q000009:adverse effects / Q000379:methods*; D010147:Pain Measurement; D011446:Prospective Studies; D056910:Republic of Korea; D016896:Treatment Outcome; D055815:Young Adult
keywords: EQ-5D; Low-level light therapy; Primary dysmenorrhea; Randomized controlled trial; Skin adhesive; Visual analog scale