Skin Adhesive Low-level Light Therapy for Primary Dysmenorrhea: A Double-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pusan National University
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Dysmenorrheal Pain Severity
Study Overview
Brief 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical diagnosis of primary dysmenorrhea.
- •a self-reported visual analog scale (VAS) for menstrual pain intensity over 7 on a scale of 0-10.
Exclusion Criteria
- •diagnosis of a serious medical or psychiatric illness, endometriosis or uterine fibroids, uterine adenomyosis, those taking oral contraceptives within the last 1 month, those who were pregnant or in whom the pregnancy test was positive were excluded.
Arms & Interventions
LLLT group
low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.
Intervention: low-level light therapy (Device)
Placebo-controlled group
Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.
Intervention: Placebo (Device)
Outcomes
Primary Outcomes
Dysmenorrheal Pain Severity
Time Frame: within 3 months after treatment
The primary outcome was menstrual pain intensity described using a 0-10 VAS scale (minimum 0, maximum 10). The higher values represent a worse outcome. All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity after the next menstruation started (pre-treatment score) using the VAS. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of pain intensity after the next menstruation started (post-treatment score) using the VAS.
Secondary Outcomes
- Quality of Life(within 3 months after treatment)
Investigators
Yong-il Shin
Associate Professor
Pusan National University