Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low-level Light Therapy for Primary Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02026206
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Yong-il Shin, Pusan National University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Primary Dysmenorrhea
Interventions Device: low-level light therapy
Device: Placebo
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LLLT Group Placebo-controlled Group
Hide Arm/Group Description

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.

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 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.

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.

Period Title: Overall Study
Started 44 44
Completed 40 36
Not Completed 4 8
Arm/Group Title LLLT Group Placebo-controlled Group Total
Hide Arm/Group Description

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.

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 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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 44 44 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 88 participants
24.0  (3.6) 25.3  (4.4) 24.6  (4.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Female
44
 100.0%
44
 100.0%
88
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 44 participants 44 participants 88 participants
44 44 88
self-reported visual analog scale (VAS) for menstrual pain intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
8.30  (1.05) 8.27  (0.92) 8.28  (0.98)
[1]
Measure Description:

The primary outcome was menstrual pain intensity described using a 0-10 VAS scale.

The higher values represent a worse outcome. All data collected by self-reported sheet.

quality of life as assessed by the EQ-5D   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
0.74  (0.20) 0.74  (0.28) 0.74  (0.24)
[1]
Measure Description: 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.
1.Primary Outcome
Title Dysmenorrheal Pain Severity
Hide Description 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.
Time Frame within 3 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LLLT Group Placebo-controlled Group
Hide Arm/Group Description:

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.

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 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.

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.

Overall Number of Participants Analyzed 40 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.88  (2.09) 6.31  (1.82)
2.Secondary Outcome
Title Quality of Life
Hide Description 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.
Time Frame within 3 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LLLT Group Placebo-controlled Group
Hide Arm/Group Description:

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.

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 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.

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.

Overall Number of Participants Analyzed 40 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.91  (0.09) 0.84  (0.14)
Time Frame Adverse event data were collected during the clinical trial period (6 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LLLT Group Placebo-controlled Group
Hide Arm/Group Description

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.

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 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.

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.

All-Cause Mortality
LLLT Group Placebo-controlled Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
LLLT Group Placebo-controlled Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      0/44 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LLLT Group Placebo-controlled Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      1/44 (2.27%)    
Endocrine disorders     
Amenorrhea * [1]  0/44 (0.00%)  0 1/44 (2.27%)  1
*
Indicates events were collected by non-systematic assessment
[1]
For two months in placebo group after treatment with placebo, amenorrhea occurred in the next menstrual cycle. The subjects were to stop using placebo medical equipment, but amenorrhea has lasted for two months. menstruation began without treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Yong-Il Shin
Organization: Pusan Natinal University Yangsan Hospital
Phone: 82-55-360-2872
EMail: rmshin01@gmail.com
Layout table for additonal information
Responsible Party: Yong-il Shin, Pusan National University
ClinicalTrials.gov Identifier: NCT02026206    
Other Study ID Numbers: PNUYH-03-2011-005
First Submitted: December 31, 2013
First Posted: January 1, 2014
Results First Submitted: January 2, 2014
Results First Posted: April 3, 2014
Last Update Posted: April 3, 2014