Vaginal Photobiomodulation for Chronic Pelvic Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 21
- 主要终点
- Overall pelvic pain
研究概览
简要总结
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.
详细描述
This clinical trial will be a multi-center, triple-masked randomized study comparing vaginal photobiomodulation to sham, for the treatment of chronic pelvic pain in women. The study will include 126 participants, 63 randomized to vaginal photobiomodulation and 63 randomized to vaginal sham treatment. Potential participants will be recruited in communities and clinics where gynecologists are routinely evaluating patients for chronic pelvic pain.
Women who fulfill inclusion criteria will undergo, screening gynecologic evaluation to ensure they can participate. Informed and written consent will be obtained from all study participants prior to enrollment.
After consent, participants will be randomized to 8 treatments with active photobiomodulation or sham administered twice a week. Study subjects will be randomized using blocked 1:1 randomization with random permuted blocks of 4. Participants, study investigators, staff, and statisticians will remain masked throughout the study and unaware of whether sham or active laser is being administered to each participant.
Treatments will be administered using the SoLá Pelvic Therapy laser, which has been modified to emit sham or active photobiomodulation through the vagina using a thin laser wand protected by a sterile plastic covering. Treatments will be administered by a gynecology providers who specialize in evaluation and management of chronic pelvic pain. The SoLá Pelvic Therapy device auto-calculates power and duration of treatment based on vaginal length. The procedure typically lasts 3-6 minutes depending on the vaginal length and the pre-determined dosing selected by the device.
Patient reported pain levels will be assessed prior to each treatment and again at 1-week and 3-months after treatment. Pain levels will be obtained from both groups at baseline and after each treatment, while demographics, pain intensity, pain impact, pain behavior, and quality of life measures (QoL) will be collected at baseline and after treatment. Need for additional therapies, global impression of change, adherence and satisfaction will be assessed after 8 treatments. To assess effect duration, both groups will be followed for an additional 3 months, after which pain levels, QoL, use of additional treatments, global health, global impression of change, and satisfaction with the procedure will be assessed. After the 3-month follow-up, participation will come to an end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Subjectively reports abnormal or decreased sensation in the vagina or rectum;
- •History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or pre-cancerous lesions;
- •History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses;
- •History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown;
- •Less than 6 months post-partum;
- •Actively trying to get pregnant or not willing to use contraception during the trial;
- •Positive pregnancy test or planning to get pregnant during the study;
- •Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; *
- •Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain;
- •Does not speak, read, or writes English and thus cannot complete surveys;
- •Does not have access to smart digital devices or computer, or cannot receive emails.
结局指标
主要结局
Overall pelvic pain
时间窗: At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.
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.
次要结局
- Symptom specific pelvic pain(At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.)
- Pain impact(At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.)
- Quality of life(At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.)
- Global physical and mental health(At baseline, at 1-week after completing treatment, and at 3 months after completing treatment.)
- Satisfaction with treatment.(At 1-week after completing treatment.)
- Adherence with treatment.(After 5 treatments are completed.)
- Need for additional treatment(This questionnaire is completed once a week, prior to each treatment through administration of all 8 treatments (which are administered twice a week), and again at 3 months after completing the last treatment.)
- Global impression of change(At 1-week after completing treatment, and at 3 months after completing treatment.)