Photobiomodulation Therapy for Myofascial Pelvic Pain: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Pelvic Pain Intensity
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of photobiomodulation of the pelvic floor muscles in female Veterans with chronic pelvic pain. The main questions it aims to answer are:
- Is there a difference in reduction in overall pelvic pain between women who undergo photobiomodulation compared to women who received pelvic floor physical therapy?
- Is there a difference in compliance with therapy between the two groups? Participants will be randomized to treatment with either 9 treatments of photobiomodulation (two treatments per week) or 8 weeks of pelvic floor physical therapy (one treatment a week). Researchers will compare both groups to see if there is a difference in overall pelvic pain reduction.
详细描述
Background:
Myofascial pelvic pain (MFPP) is defined as pain in the pelvic floor muscles, the pelvic floor connective tissue, and the surrounding fascia. Standard treatment options of MFPP include pharmacotherapy and pelvic floor physical therapy (PT). In severe cases (approximately 25%) who are not responsive to therapy, pudendal blocks and trigger point injections (TPs) may be used to temporarily alleviate pain and improve function. However, these are more invasive and may require anesthesia. Photobiomodulation therapy (PBMT) delivered by a low-level laser emitter has recently emerged as a treatment option for musculoskeletal disorders such as neck and low back pain. In patients with vaginal musculoskeletal pain, PBMT is also thought to be effective with minimal side-effects. SoLá is low-level pelvic laser emitter / photobiomodulation device that has FDA approval for intravaginal use to specifically treat myofascial pelvic pain and chronic pelvic pain. Although it is FDA approved and thought to be effective and less invasive, photobiomodulation using SoLá has not been rigorously studied in randomized controlled trials (RCTs).
Study Aims:
The primary aim is to evaluate the efficacy of SoLá pelvic therapy by comparing reduction in overall pelvic pain between women who undergo 9 treatments of photobiomodulation with SoLá (approximately 1 treatment twice a week), compared to women who receive standard pelvic floor PT once a week for 8 weeks. The secondary aim is to compare dyspareunia, pain with sitting, and compliance with therapy between the two groups.
Study Design and Methods:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinically diagnosed MFPP
- •Able to provide informed consent
- •English speaking
- •Agree not to participate in any other form of treatment of myofascial pelvic pain for 3 months after end of trial
排除标准
- •Prior pelvic floor physical therapy or SoLá therapy for pelvic pain
- •Pregnancy documented by urine or blood
- •Taking drugs that have heat- or light- sensitive contraindications
- •Reporting decreased sensation in the vagina or rectum or if they are found to have abnormalities on the external neurosensory exam of the vagina
- •Have a known history of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected to have neoplasia or pre-cancerous lesions
- •Have an active infection of the bladder, vagina, vulva, or urethra
- •Have active vaginal bleeding or blood in the vaginal canal
- •Have evidence of active vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown
- •Cannot tolerate vaginal examination either due to discomfort, pain or history or traumatic experience
结局指标
主要结局
Pelvic Pain Intensity
时间窗: 3 months post treatment
Change pelvic pain intensity using a 0-10cm visual analog scale. High score means a worse outcome.
次要结局
- Intensity of Dyspareunia(3 months post treatment)
- Intensity of pain with sitting(3 months post treatment)
- Pain interference(3 months post treatment)
研究者
Mario Castellanos
Physician
Orlando VA Medical Center