About this trial
The goal of this clinical study is to determine if 8 treatments with photobiomodulation using near-infrared laser energy can help reduce chronic pelvic pain in women. Additionally, researchers want to determine if treatment with this type of energy can also alleviate pain with activities such as standing, sitting, urinating, having bowel movements and intercourse.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older;
CPP for 3 months or longer;
Overall pelvic pain severity ≥4 in the last 7 days;
Pelvic muscle tenderness pain level ≥4.
Disqualifiers
Previous vaginal or vulvar laser therapy;
Receiving concurrent pelvic physical therapy;
Unable to tolerate vaginal/pelvic examination
Taking drugs that have heat- or light- sensitive contraindications;
Trial design
Parallel
Treatments tested in this trial
SoLa Pelvic Therapy
DeviceSoLa Pelvic Therapy laser emits near-infrared (810-980 nm wavelength) energy to the vaginal tissues. The device treats at 5-8 W for 3-6 minutes and delivers a fluence of 3,000 and 5,000 J/cm2 through a sterile vaginal probe. Specific treatment time is calculated based on vaginal length. Based on a code input, the device can cycle between emitting laser energy or sham which is visible light without focused laser energy.
Treatment groups
Trial outcomes
Primary outcomes
Overall pelvic pain
Overall pelvic pain level as measured on a 0-10 numeric rating pain scale (NRPS). On this scale, 0 represents no pain and 10 represents wors pain possible. Pain will be analyzed as median pain levels and % of participants achieving a minimal clinically important difference (MCID) defined as reduction in pain level of 2 or more NRPS points.
Secondary outcomes
Symptom specific pelvic pain
Pain with exercise, sitting, standing, bowel movements, urination, and intercourse as measured on a 0-10 numeric rating pain scale and analyzed in the same manner as the primary outcome 'overall pelvic pain'.
Pain impact
Pain intensity as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale and Pain Interference Scale. The scales assess the impact of pain on activity, mood, relationships, sleep, and general enjoyment of life. The PROMIS Pain Intensity Scale asks participants to categorize pain intensity in the last 7 days, as an ordinal categorical scale using words like 'had no pain', 'mild', 'moderate', 'severe', and 'very severe', and the PROMIS Pain Interference Scale asks participants about the degree that pain interferes with activity, work around the home, participation in social activities, things usually done for fun, enjoyment of life, family life. Participants can rank their answers as an ordinal scale using words like 'not at all', 'a little bit', 'somewhat', 'quite a bit', and 'very much'.
Quality of life
As measured by the Short Form-12 Health Survey (SF-12), a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 assess general health and well-being \[or health-related quality of life (HRQOL)\], including the impact of any and all illnesses on a broad range of functional domains. The SF-12 has two components scored on a range of 0-100: a physical component score (PCS) and a mental component score (MCS). A score of 50 or less on the PCS-12 indicates poor physical functioning or a physical condition, because scores above 50 indicate better than average health related quality of life, while a score below 50 suggests below average health. A score of 42 or less on the MCS-12 may indicate clinical depression. Therefore, SF-12 scores above 50 indicate better health and scores below 50 indicate worse than average health.
Global physical and mental health
Global physical and mental health as measured by the PROMIS Global Health questionnaire. It contains questions that allows participants to rank their general physical health, ability to carry out every day physical activities such as walking, climbing stairs, carry groceries, or moving a chair, using an ordinal scale ranking 'excellent', 'very good', 'good', 'fair', and 'poor'. This questionnaire also contains questions that allows participants to rate their mental health including ability to think, and satisfaction with social activities and relationships on an ordinal scale ranking 'excellent', 'very good', 'good', 'fair', and 'poor'.
Sponsors and contacts
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SoLa Pelvic Therapy
Lead sponsor
Uroshape LLC
Collaborator