Trial Outcomes & Findings for Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief (NCT NCT02204319)
NCT ID: NCT02204319
Last Updated: 2017-07-02
Results Overview
III. Q-tip testing: . Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment. • Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS
TERMINATED
NA
10 participants
Average of all sites Compared from baseline visit and at 8 week (from start) follow up
2017-07-02
Participant Flow
Participant milestones
| Measure |
Cold Laser Treatment
Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Cold Laser Treatment
Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.
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Overall Study
Pregnancy
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1
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief
Baseline characteristics by cohort
| Measure |
Cold Laser Recipients
n=10 Participants
10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing at each treatment visit. There was also a two week follow up scheduled for re-assessment.
Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities.
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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10 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Average of all sites Compared from baseline visit and at 8 week (from start) follow upIII. Q-tip testing: . Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment. • Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS
Outcome measures
| Measure |
Cold Laser Treatment
n=7 Participants
Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.
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Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit
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76.52 percent change from first to last Rx
Standard Deviation 24.36
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SECONDARY outcome
Timeframe: Baseline, and two weeks following last treatment at Week 8Population: women average 26+/- 5.533 Years of age who were not pregnant with appropriate diagnoses
Questionnaire that measures on a 0-10 scale (0= No function, and 10= normal function) one function that most impacts the patient's present symptoms (vaginal penetration/intercourse chosen as most important and pertinent) Measured amount of point change on the scale.
Outcome measures
| Measure |
Cold Laser Treatment
n=7 Participants
Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.
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Change in Patient Specific Functional Scale Questionnaire
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5.25 units on a scale
Standard Deviation 1.15
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and after last treatment visit at Week 8Population: women average age of 26 +/- 5.533 Years with appropriate diagnoses
Questionnaire of eleven questions involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. Questions have 4-5 answer choices weighted on a 0-3 scale of impairment, with 3 being worst. Worst reported score of functional impact =33. No functional impact = 0
Outcome measures
| Measure |
Cold Laser Treatment
n=7 Participants
Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.
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Change in the Vulvar Pain Functional Scale Questionnaire
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32.89 percent change
Standard Deviation 2.63
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Adverse Events
Cold Laser Light Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place