Clinical trial NCT02026206: Low-level Light Therapy for Primary Dysmenorrhea
Official title: Skin Adhesive Low-level Light Therapy for Primary Dysmenorrhea: A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea
Pain
Lead sponsor: Pusan National University
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dysmenorrheal Pain Severity
timeFrame: within 3 months after treatment
Secondary outcomes:
measure: Quality of Life
timeFrame: within 3 months after treatment
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong-Il Shin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Gi-Youn Hong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin YI, Kim NG, Park KJ, Kim DW, Hong GY, Shin BC. Skin adhesive low-level light therapy for dysmenorrhoea: a randomized, double-blind, placebo-controlled, pilot trial. Arch Gynecol Obstet. 2012 Oct;286(4):947-52. doi: 10.1007/s00404-012-2380-9. Epub 2012 May 31.
citation: Hong GY, Shin BC, Park SN, Gu YH, Kim NG, Park KJ, Kim SY, Shin YI. Randomized controlled trial of the efficacy and safety of self-adhesive low-level light therapy in women with primary dysmenorrhea. Int J Gynaecol Obstet. 2016 Apr;133(1):37-42. doi: 10.1016/j.ijgo.2015.08.004. Epub 2015 Dec 2.