Low-level Light Therapy for Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the effectiveness of a self-therapeutic approach of
      skin adhesive low-level light therapy (LLLT) in females with primary dysmenorrhea (PD).
    

Detailed description: 
      Study design: This was a prospective, randomized, double-blind, placebo-controlled,
      multi-centered trial carried out at two university hospitals. This clinical trial was
      approved by the Korea Food and Drug Administration and the Institutional Review Boards of the
      two hospitals.

      Study process:

      All patients gave informed written consent after being informed of the details of the study.
      Participants were permitted to take analgesics when severe or difficult to control pain
      occurred. Participants were randomized into either the LLLT or placebo control groups at the
      third visit. All participants underwent demographic and history taking, a physical
      examination, an obstetrics and gynecology examination, ultrasound, and laboratory tests. All
      participants were educated on how to use the device by demonstration and a picture-guided
      user manual.

      During the second visit, the participants conducted a self-evaluation of pain intensity and
      quality of life after the next menstruation started (pre-treatment score) using the VAS and
      EQ-5D questionnaire. The third visit occurred at least 5-7 days from the date of the next
      menstruation, and a clinical primary nurse described how to use the medical equipment and
      devices when they were at home. All subjects were to perform the LLLT 20 min/day for 5 days
      from the start of menstruation. Within 3 days after menstruation started the subjects
      self-assessed their pain using the VAS after treatment (first post-treatment score). Subjects
      carried out the self-treatment in the same way at home 5-7 days before the start of their
      next period and then visited the hospital for the fifth time to record their pain on the VAS
      (second post-treatment score). As before, self-therapy was performed 5-7 days before the next
      menstruation started. The sixth visit occurred within 1-3 days after menstruation began, just
      as before, and all subjects performed the self-evaluation (third post-treatment score) using
      the EQ-5D questionnaire and VAS for menstrual pain intensity.

      Statistical analysis:

      All data are summarized as means ± standard deviation or as numbers with proportions. A p <
      0.05 was considered to indicate significance. We decided that the therapeutic effect would be
      a > 30% reduction in the VAS value after treatment. The statistical analysis was conducted
      using the VAS assessment score after the third treatment as the primary endpoint. We used an
      independent t-test to evaluate differences in each group between VAS pain scores measured
      after the third treatment and baseline values. The influence of variance in each group after
      pre-treatment, primary treatment, secondary treatment, and tertiary treatment were verified
      through repeated-measures analysis of variance (ANOVA). We analyzed the differences in the
      EQ-5D in each group using analysis of covariance (ANCOVA). Age was considered a covariate.
      Any differences between the groups for the use of painkillers were analyzed by Fisher's exact
      test. If there was any difference in the use of pain killers between groups, the influence of
      pain killer use was closely checked by ANCOVA. A per-protocol (PP) analysis was used in our
      clinical trial to assess efficacy and safety.
    

Intervention name(s): low-level light therapy; Placebo
Intervention type(s): Device; Device
Intervention description(s): we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.; we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
Other intervention name(s): Color DNA-WSF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary Dysmenorrhea; Pain