Low-level Light Therapy for Primary Dysmenorrhea

• 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: Pusan National University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	LLLT Group	Placebo-controlled Group
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

Baseline Characteristics

Arm/Group Title		LLLT Group	Placebo-controlled Group	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Dysmenorrheal Pain Severity
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LLLT Group	Placebo-controlled Group
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LLLT Group	Placebo-controlled Group
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)

Adverse Events

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
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	--/--		--/--
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%)
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.

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Professor Yong-Il Shin
• Organization: Pusan Natinal University Yangsan Hospital
• Phone: 82-55-360-2872
• EMail: rmshin01@gmail.com

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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