Effectiveness and Cost-utility of Somatocognitive Therapy Versus Treatment as Usual for Provoked (Localized) Vestibulodynia - a Randomized Clinical Trial (ProLoVe Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in female sexual function index (FSFI) (Rosen et al. 2000)
研究概览
简要总结
This is a two-arm randomized clinical trial assessing effectiveness of somatocognitive therapy versus treatment as usual for provoked vestibulodynia (PVD). PVD is a common, but under-treated persistent pain condition, mostly affecting young women in their late teens and early 20s. It is the most frequent cause of pain during sexual intercourse affecting around 10% of women in the general population. There are no generally accepted evidence-based guidelines for the medical management of PVD. The most commonly used treatments are topical (85%), physiotherapy (52%), and oral medications (45%). High quality randomized clinical trials testing effectiveness of various therapy approaches are urgently needed.
Somatocognitive therapy SCT is a multi-modal physiotherapy approach developed for alleviating musculoskeletal persistent pain conditions. SCT has been previously evaluated in the treatment of women with chronic pelvic pain.
In the current study, 128 women with PVD will be randomized into SCT and treatment as usual (TAU) group. Participants will be assessed at baseline, after 6 months and after 12 months. The main outcome will be changes in female sexual function index scored at 12 months follow up. Secondary outcomes include pain intensity as assessed by a tampon test as well as a number of questionnaires recording different aspects of emotional and cognitive functioning. In addition cost-effectiveness analysis of SCT versus TAU will be performed.
Participants in the SCT group will receive up to 15 therapy sessions and will additionally be offered one booster session at 6 months after treatment ending. TAU group will follow treatment options of their own choice based on recommendations from the Vulva clinic at Oslo University Hospital, a center that is specialized in treating women with vulvar pain conditions.
详细描述
Objectives:
The main objectives of the ProLoVe study are:
- To assess clinical effectiveness of somatocognitive therapy (SCT) versus treatment as usual (TAU) in provoked vestibulodynia (PVD).
- To identify prognostic factors associated with treatment outcome
- To assess cost-effectiveness and cost-utility of SCT vs TAU.
Study design:
The study is a two-arm, single center randomized clinical trial with a 1:1 allocation ratio, recruiting patients with PVD diagnosis. The participants will be randomized to either somatocognitive therapy (SCT) or treatment as usual (TAU) group after baseline assessment. Randomization will be stratified by type of PVD (primary or secondary), since primary PVD is considered to be more treatment resistant.
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)
盲法说明
Statistician analyzing the data will be blinded for group belonging
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of provoked vestibulodynia
- •Age: 18 to 35
- •Must understand Norwegian well enough to be able to complete questionnaires
- •Must be able to attend treatment in Oslo, Norway
排除标准
- •Active infection in the vulvar region
- •Dermatologic lesion in the vulvar region
- •Presence of diagnostically confirmed psychiatric condition that necessitate treatment by a medical specialist in psychiatry of clinical psychology
研究组 & 干预措施
Somatocognitive physiotherapy
Somatocognitive therapy is a multi-modal physiotherapy intervention utilized for women with longstanding chronic pelvic pain and provoked vestibulodynia developed at the beginning of the 2000s as a collaboration between the department of psychosomatic medicine, Oslo University Hospital (OUH) and department of physiotherapy (OsloMet)
干预措施: Somatocognitive physiotherapy (Other)
Treatment as usual
The participants randomized to the treatment as usual group will follow available treatment options based on the current recommendations from Vulva clinic at Oslo University Hospital, a center that is specialized in treatment of vulvar conditions.
干预措施: Treatment as usual (Other)
结局指标
主要结局
Change in female sexual function index (FSFI) (Rosen et al. 2000)
时间窗: Baseline, 6 and 12 months follow up
A multidimensional scale assessing key dimensions of female sexual function. The FSFI is a 19-item self-report questionnaire designed to measure sexual functioning in women. It assesses six domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain (i.e., pain associated with vaginal penetration). Higher scores indicate better sexual functioning.
次要结局
- Change in Participant Perceived Improvement (PGIC) (Dworkin et al. 2005)(6 and 12 months follow up)
- Change in the tampon test (Foster et al. 2009)(Baseline, 6 and 12 months follow up)
- Change in recalled pain intensity during intercourse(Baseline, 6 and 12 months follow up)
- Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - life interference(Baseline, 6 and 12 months follow up)
- Change in Vulvar Pain Assessment Questionnaire (VPAQ) (Dargie et al. 2017) - coping strategies(Baseline, 6 and 12 months follow up)
- Change in vulvodynia related self-efficacy(Baseline, 6 and 12 months follow up)
- Change in pain catastrophizing scale (Fernandes et al. 2012)(Baseline, 6 and 12 months follow up)
- Change in Rumination Response Scale (RRS-10) (Parola et al. 2017)(Baseline, 6 and 12 months follow up)
- Change in Hopkins Symptoms Check List (HSCL-25) (Derogatis et al.1974)(Baseline, 6 and 12 months follow up)
- Change in EQ-5D-5L (Herdman et al. 2011)(Baseline, 6 and 12 months follow up)