Low-level Light Therapy for Primary Dysmenorrhea

NCT02026206 | Completed Phase 3 Results DMC

• 1 other identifier: PNUYH-03-2011-005
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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).

Conditions

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quality of Life

  within 3 months after treatment

Study Arms (2)

LLLT group

EXPERIMENTAL

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.

Device: low-level light therapy

Placebo-controlled group

PLACEBO COMPARATOR

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.

Device: Placebo

Interventions

low-level light therapy DEVICE

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.

Also known as: Color DNA-WSF

LLLT group

Placebo DEVICE

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.

Placebo-controlled group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinical diagnosis of primary dysmenorrhea.
• a self-reported visual analog scale (VAS) for menstrual pain intensity over 7 on a scale of 0-10.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University: lead

Study Sites (2)

Wonkwang University Hospital

Iksan, 570-711, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 626-770, South Korea

Location

Related Publications (2)

• 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.

  PMID: 22648444 BACKGROUND

• 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.

  PMID: 26797192 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Professor Yong-Il Shin
• Organization: Pusan Natinal University Yangsan Hospital

rmshin01@gmail.com

82-55-360-2872

Study Officials

• Yong-Il Shin, Ph.D.

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

• Gi-Youn Hong, Ph.D.

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 1, 2014
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 3, 2014
• Results First Posted: April 3, 2014

Record last verified: 2014-02

Locations

KR (2)