ACTRN12626000825358进行中（未招募）不适用
A single-arm feasibility and dose-escalation study of dorsal root ganglion-targeted photobiomodulation for endometriosis-associated persistent pelvic pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（—）
- 性别
- Female
入选标准
- •Individuals assigned female at birth aged 18–39 years
- •Confirmed endometriosis (imaging or histopathology)
- •Persistent pelvic pain of 3 months or greater, localised to pelvic/lumbopelvic region
- •Pain consistent with segmental/central sensitisation, defined by:
- •– Convergences Pelvic Pain Score (CPPS) score of 5 or greater
- •– Fibromyalgia Patient Self-Report Survey (FM Survey) score of 1–11
- •Preserved but hormonally regulated ovarian function (not fully suppressed)
- •Stable hormonal regimen
- •Body Mass Index (BMI) 18–30 kg/m²
- •Fitzpatrick skin type I–III
- •Able to provide consent and comply with study procedures
排除标准
- •Pregnancy or breastfeeding
- •Absent, suppressed, or unregulated ovarian function (e.g. menopause, GnRH therapy, natural cycling without regulation)
- •Pain profile inconsistent with pelvic sensitisation (CPPS score of less than 5; FM Survey score of 12 or greater)
- •Clinically significant PTSD or neurodevelopmental conditions affecting sensory processing (e.g. ADHD, ASD)
- •Unstable medical or psychiatric illness
- •Contraindications to PBM (e.g. implanted devices, photosensitivity, impaired sensation at treatment sites)
- •Recent pelvic pathology (infection, significant bleeding, or surgery within 3 months)
- •Active malignancy or serious systemic disease
- •BMI outside 18–30 kg/m² or Fitzpatrick IV–VI
- •Inability to comply with study procedures or provide informed consent