Multidisciplinary Treatment of Chronic Vulvar Pain - a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Pain intensity with Brief pain inventory (BPI)
研究概览
简要总结
Vulvodynia (i.e. chronic vulvar pain without identifiable cause) is a heterogeneous clinical entity with a complex multifactorial causation. It is long lasting and difficult to treat, and the general consensus of current guidelines states that patients with vulvodynia benefit from a compound multidisciplinary intervention targeting mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. However, there is little empiric evidence to support this recommendation. This will be a randomized controlled trial comparing multidisciplinary treatment with standard care for women with vulvodynia.
详细描述
Patients with chronic vulvar pain constitute a heterogeneous group with regards to causes and moderators of pain. Multidisciplinary teams simultaneously assess contributing factors such as infections and dermatoses and treat known mediators of pain, namely mucosal hypersensitivity, pelvic muscle floor dysfunction and general pain management. Treatment as usual, on the other hand, is primarily based on a sequential model applying one type of treatment at a time.
The investigator's aim is to compare multidisciplinary treatment including multimodal physiotherapy (intervention group) with standard treatment (control group) in reducing pain, sexual dysfunction and related symptoms in women with vulvodynia.
The study sample will be allocated randomly 1:1 to multidisciplinary treatment by a vulva team or to standard treatment by a specialist in gynaecology. The intervention will include a joint consultation by a gynaecologist and a dermatologist, tailored multimodal physiotherapy by a physiotherapist and guided imagery (mindfulness and relaxation) by use of a sound track during home sessions. The controls will receive standard care by a gynaecologist, who is free to offer any kind of non-standardized treatment.
Treatment effect will be measured at 3 months and at 6-12 months after inclusion.
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
- Single (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
- •Women aged 18 years and older
- •Chronic vulvar pain for ≥3 months of duration
排除标准
- •Insufficient Norwegian skills
- •Intellectual disability or severe mental disorder
- •Severe comorbidity making tailored care necessary (such as active cancer treatment)
结局指标
主要结局
Pain intensity with Brief pain inventory (BPI)
时间窗: Baseline, 3 months and 6 months (change)
Intensity of pain measured with BPI using the mean of the 4 subscales (current, averaged, maximum and minimum pain during the last week) on a 0-10 numerical rating scale (0 minimum and 10 maximum pain)
次要结局
- Pain intensity with Brief pain inventory (BPI)(Baseline, 3 months, 6 months and 12 months (change))
- Pain intensity with tampon test(Baseline, 6 months and 12 months (change))
- Vulvar pressure pain threshold with vulvalgesiometer(Baseline, 6 months and 12 months (change))
- Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)(Baseline, 6 months and 12 months (change))
- Sexual distress with Female Sexual Distress Scale - revised (FSDS)(Baseline, 6 months and 12 months (change))
- Affective symptoms with Hospital Anxiety and Depression Scale (HADS)(Baseline, 6 months and 12 months (change))
- Illness perception with Brief Illness Perception Questionnaire (BIPQ)(Baseline, 6 months and 12 months (change))
- Pain catastrophizing with Pain Catastrophizing Scale (PCS)(Baseline, 6 months and 12 months (change))
- Levator hiatal area(Baseline, 6 months and 12 months (change))