Assessing the Feasibility of Somatosensory Rehabilitation and Pain Management Programs in Women With Provoked Vestibulodynia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Adherence rate to home exercises
研究概览
简要总结
The feasibility and acceptability of a somatosensory rehabilitation program and an educational pain management program will be investigated in women with provoked vestibulodynia. Forty-four women will be randomized into the two groups. The secondary objective is to explore the effects of the somatosensory rehabilitation program compared to the pain management program. Each participant will receive 12 weekly sessions with a physiotherapist.
The somatosensory rehabilitation program includes minimizing contact with the painful zone of the vulva and uses repeated tactile stimulation at a tolerated distance, proximal to the vulva. The pain management program includes teaching participants about vulvar hygiene, chronic pain mechanisms, relaxation techniques, and approaches to reduce skin irritations in painful regions. Participants in both groups will also receive advice on sexual function and steps toward resuming sexual activities with vaginal penetration.
Feasibility and acceptability outcomes will be assessed and analyzed using descriptive statistics for the adherence rates to treatment sessions and home exercises, the recruitment rate, retention rate, satisfaction, and adverse effects. The results will be compared to predetermined thresholds to determine the feasibility and acceptability of a future clinical trial.
Secondary measures will be assessed at baseline, two weeks after the treatment, and at three months follow-up. These outcomes will be assessed using validated questionnaires (pain, sexual function, global impression of change, psychological variables, quality of life) as well as evaluations of tactile and pressure sensitivity in vulvar regions using monofilaments, a 2-point aesthesiometer and an algometer. Linear mixed models for repeated measurements (2 groups, 3 measurement times) will be used to explore the treatment effects and will contribute to determining the feasibility of a future clinical trial.
Hypothesis and expected results: It is expected that both programs will meet the pre-determined criteria for acceptability and feasibility in women with provoked vestibulodynia. This study will provide guidance for a future randomized clinical trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of provoked vestibulodynia according to a standardized gynaecologic exam
- •Moderate to severe pain (≥5/10) located in the vulvar vestibule for at least 90% of vaginal penetrations or attempted vaginal penetrations or activities with pressure on the vagina for at least 3 months
排除标准
- •Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- •Prior vulvo-vaginal surgery or radiotherapy
- •Post-menopausal status
- •Participant refusal to not use other treatments for the provoked vestibulodynia during the entire study (until 3 months post-treatment);
- •Other urogynecological condition (e.g. pelvic organs prolapse ≥3, current urinary/vaginal infection or in the last 3 months)
- •Prior use of Somatosensory Rehabilitation Program or Educational Pain Management Program
- •Current or past pregnancy in the last year;
- •Changes of medication that could influence pain perception (e.g. analgesic, antidepressant) in the last 3 months
- •Major psychological condition (e.g. depressive symptoms, anxiety) which can present a security issue for the participant
- •Other medical conditions that could interfere with the study
结局指标
主要结局
Adherence rate to home exercises
时间窗: From first to last session (baseline to 12th week)
The adherence rate to home exercises for each treatment group will be assessed using a daily diary. The participants will record the frequency and duration of the exercises completed.
Patients' adherence rate to treatment sessions
时间窗: From first to last session (baseline to 12th week)
The patients' adherence to treatment sessions will be recorded in the participants' treatment files (present vs absent).
Retention rate
时间窗: Baseline to 3 months post-treatment evaluation
The retention rate will be assessed by calculating the ratio of participants who stay in the study until the post-intervention and 3-month follow-up assessments. Reasons for dropouts will be collected.
Recruitment rate
时间窗: At baseline only (during the recruitement period)
The recruitment rate will be recorded as the average number of participants recruited per month as well as the participant accrual rate (participants enrolled / participants screened for diagnosis). Reasons for refusing to participate will be documented if the participant consents to inform the study's research team.
Therapists treatment adherence
时间窗: From first to last session (baseline to 12th week)
The therapists' treatment adherence will be assessed within the therapists' files to verify that all the interventions' key components were applied and respected.
Adherence rate to assessment sessions
时间窗: Baseline to 3 months post-treatment evaluation
The adherence to assessment sessions (present vs absent) will be recorded in the participants' assessment files. The reasons for absences will be documented.
次要结局
- Credibility and Expectancy Questionnaire(At baseline only (before the initiation of the treatment))
- Patients' Global Impression of Change and Satisfaction(At 2-week post-treatment and 3 months post-treatment)
- Intervention Acceptability Questionnaire(At 2-week post-treatment and at 3 months post-treatment)
- Self-Efficacy Question(At baseline, 6 week after the initiation of treatment, and at the last treatment (12th week))
- Adverse events(2-week and 3 months post-treatment)
- Female Sexual Function Index (FSFI)(Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Pain intensity during intercourse (Numerical Rating Scale)(Changes from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Pain quality (McGill-Melzack questionnaire-short form)(Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Vulvar sensitivity(Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Vulvar tactile allodynia area(Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Female Sexual Distress Scale (FSDS)(Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Vulvar tactile alllodynia severity(Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Vulvar tactile sensibility(Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Two-point discrimination test(Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Beck Depression Inventory questionnaire (BDI-II)(Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Pain Anxiety Symptoms Scale (PASS-20)(Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Pain Catastrophizing Scale (PCS)(Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
- Vaginal Penetration Cognition Questionnaire (VPCQ)(Change in the scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment)
- 12-item Short Form Survey (SF-12 v2)(Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment)
研究者
Mélanie Morin
Researcher and Full Professor
Université de Sherbrooke