Low-level Light Therapy for Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Skin Adhesive Low-level Light Therapy for Primary Dysmenorrhea: A Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026206
• Other study ID #: PNUYH-03-2011-005
• Status: Completed
• Phase: Phase 3
• First received: December 31, 2013
• Last updated: February 20, 2014
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: February 2014
• Source: Pusan National University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• low-level light therapy
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.
• Placebo
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.

Locations

Country	Name	City	State
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysmenorrheal Pain Severity	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.	within 3 months after treatment	No
Secondary	Quality of Life	The secondary outcome measures were quality of life as assessed by the EQ-5D (minimun 0.00, maximum 1.00). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The subscales combined to compute a total score according to EQ-5D equation formula. The higher values represent a better outcome.All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity and quality of life after the next menstruation started (pre-treatment score) using the EQ-5D questionnaire. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of quality of life after the next menstruation started (post-treatment score) using the EQ-5D questionnaire.	within 3 months after treatment	No