Trial Outcomes & Findings for Low-level Light Therapy for Primary Dysmenorrhea (NCT NCT02026206)
NCT ID: NCT02026206
Last Updated: 2014-04-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
88 participants
Primary outcome timeframe
within 3 months after treatment
Results posted on
2014-04-03
Participant Flow
Participant milestones
| Measure |
LLLT Group
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.
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Placebo-controlled Group
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.
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|---|---|---|
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Overall Study
STARTED
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44
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44
|
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Overall Study
COMPLETED
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40
|
36
|
|
Overall Study
NOT COMPLETED
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4
|
8
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-level Light Therapy for Primary Dysmenorrhea
Baseline characteristics by cohort
| Measure |
LLLT Group
n=44 Participants
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-controlled Group
n=44 Participants
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.
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Total
n=88 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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24.0 years
STANDARD_DEVIATION 3.6 • n=39 Participants
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25.3 years
STANDARD_DEVIATION 4.4 • n=41 Participants
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24.6 years
STANDARD_DEVIATION 4.1 • n=35 Participants
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Sex: Female, Male
Female
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44 Participants
n=39 Participants
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44 Participants
n=41 Participants
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88 Participants
n=35 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=39 Participants
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0 Participants
n=41 Participants
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0 Participants
n=35 Participants
|
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Region of Enrollment
Korea, Republic of
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44 participants
n=39 Participants
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44 participants
n=41 Participants
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88 participants
n=35 Participants
|
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self-reported visual analog scale (VAS) for menstrual pain intensity
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8.30 units on a scale
STANDARD_DEVIATION 1.05 • n=39 Participants
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8.27 units on a scale
STANDARD_DEVIATION 0.92 • n=41 Participants
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8.28 units on a scale
STANDARD_DEVIATION 0.98 • n=35 Participants
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quality of life as assessed by the EQ-5D
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0.74 units on a scale
STANDARD_DEVIATION 0.20 • n=39 Participants
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0.74 units on a scale
STANDARD_DEVIATION 0.28 • n=41 Participants
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0.74 units on a scale
STANDARD_DEVIATION 0.24 • n=35 Participants
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PRIMARY outcome
Timeframe: within 3 months after treatmentThe 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.
Outcome measures
| Measure |
LLLT Group
n=40 Participants
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-controlled Group
n=36 Participants
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.
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|---|---|---|
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Dysmenorrheal Pain Severity
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3.88 units on a scale
Standard Deviation 2.09
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6.31 units on a scale
Standard Deviation 1.82
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SECONDARY outcome
Timeframe: within 3 months after treatmentThe 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.
Outcome measures
| Measure |
LLLT Group
n=40 Participants
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-controlled Group
n=36 Participants
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.
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|---|---|---|
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Quality of Life
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0.91 units on a scale
Standard Deviation 0.09
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0.84 units on a scale
Standard Deviation 0.14
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Adverse Events
LLLT Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo-controlled Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LLLT Group
n=44 participants at risk
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-controlled Group
n=44 participants at risk
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.
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|---|---|---|
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Endocrine disorders
Amenorrhea
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0.00%
0/44 • Adverse event data were collected during the clinical trial period (6 months)
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2.3%
1/44 • Number of events 1 • Adverse event data were collected during the clinical trial period (6 months)
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Additional Information
Professor Yong-Il Shin
Pusan Natinal University Yangsan Hospital
Phone: 82-55-360-2872
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place