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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Il Shin, Ph.D. | Pusan National University Yangsan Hospital | Principal Investigator |
| Gi-Youn Hong, Ph.D. | Wonkwang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonkwang University Hospital | Iksan | 570-711 | South Korea | |||
| Pusan National University Yangsan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22648444 | Background | 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. | |
| 26797192 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | within 3 months after treatment |
|
Adverse event data were collected during the clinical trial period (6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amenorrhea | Endocrine disorders | Non-systematic Assessment | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Yong-Il Shin | Pusan Natinal University Yangsan Hospital | 82-55-360-2872 | rmshin01@gmail.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
| 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. |
|
| within 3 months after treatment |
| Yangsan |
| 626-770 |
| South Korea |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| self-reported visual analog scale (VAS) for menstrual pain intensity | 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. | Mean | Standard Deviation | units on a scale |
|
| quality of life as assessed by the EQ-5D | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | within 3 months after treatment |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | 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. | 0 | 44 | 1 | 44 |
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