Endometriosis Deep Dyspareunia and Central Sensitization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Deep dyspareunia score
研究概览
简要总结
Background: Endometriosis affects 10% of reproductive aged females, and can have a negative impact on sexual quality of life. Endometriosis can cause pelvic pain with deep penetration during intercourse, as well as other sexual and non-sexual pains. This study will allow us to determine if an increase in sexual pain is related to central sensitization.
Purpose: The purpose of this study is to determine if there is an association between the severity of sexual pain and central sensitization in women with endometriosis.
Measurement tools: Data will be collected from the Clinic's Data Registry, an online questionnaire, a quantitative sensory test (QST) to measure pain-pressure threshold (PPT) as a marker of central sensitization, and daily entry to an online survey.
Primary Hypothesis: Central sensitization (measured by lower pain-pressure threshold) will be associated with an increased severity of deep dyspareunia, as well as a tenderness of the bladder/pelvic floor and depression, in women with endometriosis.
详细描述
Background:
Endometriosis results from the presence of endometrial cells growing abnormally outside the uterus and affects approximately 10% of reproductive-aged females. Endometriosis can be associated with various types of pain such as: dysmenorrhea (painful cramps with menses), deep dyspareunia (pelvic pain with deep penetration during intercourse), dyschezia (painful bowel movements) and chronic pelvic pain. Few studies have explored the association between endometriosis and deep dyspareunia resulting in a limited understanding of how to treat deep dyspareunia. Deep dyspareunia is defined as pelvic pain with deep penetration and occurs in 50% of women with endometriosis at some time in their sexual lives. Deep dyspareunia has been shown to lower or cease intercourse, thus lowering self-esteem and resulting in negative effects on sexual functioning and interpersonal relationships.
A potential contributor to deep dyspareunia in women with endometriosis that is largely under-researched is the concept of central sensitization. Central sensitization is an amplification of nociceptive signaling that may result from prolonged pain causing sensitization of the dorsal horn neurons, which results in hyperalgesia (increased response to pain) and allodynia (response to pain when there normally would not be). A recent study, comparing cross-sectional data from suspected or surgically diagnosed endometriosis patients, suggested that bladder and pelvic floor tenderness may be markers of central sensitization. However, the linkage between the indirect markers of central sensitization and the presence of central sensitization requires confirmation. This link can be assessed through validated quantitative sensory testing (QST). Likewise, the association between central sensitization and deep dyspareunia may also be confirmed through QST. QST is an objective measurement tool to determine the presence and/or degree of sensory disturbances, by detecting the alterations in nociceptive pathways. For example, a low pain-pressure threshold (i.e., increased pain sensation) at healthy unaffected areas, as measured by QST, indicates central sensitization.
Purpose: To determine if deep dyspareunia is associated with central sensitization in women with endometriosis.
Research Question: Is deep dyspareunia associated with central sensitization assessed by decreased pain-pressure threshold?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Consented to participate in the Data Registry (H16-00264) prior to their physician appointment at the BC Women's Health Centre.
- •New or re-referred to the BC Women's Health Centre for Pelvic Pain and Endometriosis.
- •Endometriosis (previously surgically diagnosed, or current endometrioma, or current nodule)
- •Willing and committed to indicating pain scores and menstrual data on a REDCap survey every day for 6 weeks after the test date.
- •At least 18 years old
- •Reproductive aged female with no suspected or diagnosed endometriosis.
- •Have not experienced any sexual pain scores over 4/10 on a 11-point numeric rating scale, as determined on an online questionnaire prior to test day.
- •At least 18 years old
排除标准
- •Case and Control:
- •Fibromyalgia.
- •Severe and enduring psychological illness(es) affecting cognition (e.g., bipolar disorder, schizophrenia etc.).
- •Currently pregnant or breastfeeding.
- •Have a peripheral or central neurological disorder.
- •Have diabetes mellitus or neuropathic pain.
- •Do not speak English.
- •Have had previous physical trauma (ex. Surgery) to the test site(s) (deltoid muscle in the shoulder, and first dorsal interosseous muscle).
结局指标
主要结局
Deep dyspareunia score
时间窗: Case and Control:1 day (same day as the QST testing date), and Case only: daily for 6 weeks after QST testing date
Self reported on an 11-point numeric rating scale (10 being worst pain imaginable)
次要结局
- Superficial Dyspareunia score(Case and Control:1 day (same day as the QST testing date), and Case only: daily for 6 weeks after QST testing date)
- Depression(Case only: 1 day (one week before the QST testing date))
- Bladder and pelvic floor tenderness(Case only: 1 day (one week before the QST testing date))
- Chronic pelvic pain score(Case and Control:1 day (same day as the QST testing date), and Case only: daily for 6 weeks after QST testing date)
- Catastrophizing(Case only: 1 day (one week before the QST testing date))
- Dysmenorrhea score(Case and Control:1 day (same day as the QST testing date))
- Anxiety(Case only: 1 day (one week before the QST testing date))
研究者
Paul Yong
Principal Investigator and Research Director, BC Women's Centre for Pelvic Pain and Endometriosis.
BC Women's Hospital & Health Centre