Efficacy of Transcranial Direct-Current Stimulation (tDCS) for Provoked Vestibulodynia : a Triple Blind Randomized Controlled Trial (PVD/tDCS)
2017年5月1日 更新者：Mélanie Morin、Université de Sherbrooke
Provoked vestibulodynia (PVD) is the most common form of vulvodynia and despite its high prevalence and important sexual, conjugal and psychological deleterious repercussions, effective evidence-based interventions remain limited.
For a high proportion of women, significant pain persists despite the currently available treatments.
Transcranial direct-current stimulation (tDCS) was shown to be effective in various chronic pain conditions.
So far, only one case report study has shown significant pain reduction in women with vulvodynia.
The main goal of this randomized controlled trial is to evaluate the efficacy of tDCS in women with PVD compared to sham tDCS.
Forty women diagnosed with PVD, by a gynecologist following a standardized protocol will be randomized to either active or sham tDCS for ten 20 minute sessions of 2 mA stimulation over a 2-week period.
Outcome measures will be collected at baseline, after treatment and at 3-month follow-up.
The primary outcome is pain during intercourse assessed with a numerical rating scale (NRS).
Secondary measurements focus on sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction and Patient Global Impression of Change (PGIC).
The investigators expect that active tDCS treatment will significantly reduce pain during intercourse (post-treatment and 3-month follow-up compared to pre-treatment assessment).
This trial will provide important information for determining the efficacy of a novel and promising intervention for women with PVD.
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Quebec
-
Sherbrooke、Quebec、加拿大、J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
-
Sherbrooke、Quebec、加拿大、J1H 5N4
- Centre hospitalier Universitaire de Sherbroke
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
17年 至 45年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Experience moderate to severe pain in at least 90% of attempted sexual intercourse;
- Experience moderate to severe pain during cotton swab test, in one or more regions of the vestibule (minimum of 5/10 on a subjective numeric scale of pain intensity);
- Pain limited to the vestibule during vaginal intercourse and during activities exerting pressure on the vestibule (tampon insertion, tight jeans or pants, cycling, horseback riding);
- Presence of PVD for at least 6 months and diagnosed according to the standardized gynecological examination protocol by one of our staff gynecologists;
- Have a stable sexual partner with regular sexual activity including penetration.
Exclusion Criteria:
- Other pelvic pathology associated with pelvic pain (e.g., deep dyspareunia);
- Chronic pain conditions (e.g. fibromyalgia, low back pain, chronic migraines);
- Use of medication that can influence the perception of pain (eg analgesic, opioids, antiepileptic, muscle relaxant);
- Pregnancy for less than one year and breastfeeding;
- Anterior vulvar or vaginal surgery;
- Refusal to refrain from other treatments one month prior to first treatment study until the last 3-month follow-up assessment;
- Important urogynecologic symptoms (urinary or anal incontinence, urinary urgency, pelvic organ prolapse, active urinary tract or vaginal infection or earlier in the last 3 months, etc.);
- Contraindications to tDCS (e.g. metallic implant in or near the skull, history of epilepsy, pacemaker);
- Previously received tDCS treatment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention
Participants will receive active transcranial direct-current stimulation (tDCS) for ten 20 minute sessions of 2 mA stimulation over a 2-week period.
|
tDCS is a painless technique which consists in applying low direct-current through electrodes (one electrode serving as an anode, the other as a cathode) placed on the scalp to target the cerebral cortex.
In patients with chronic pain, the anode is commonly placed over the motor cortex (M1) (Valeriani et al., 1999).
其他名称：
|
|
假比较器：Placebo
Participants will receive sham transcranial direct-current stimulation (tDCS) for ten 20 minute sessions of 2 mA stimulation over a 2-week period.
|
tDCS is a painless technique which consists in applying low direct-current through electrodes (one electrode serving as an anode, the other as a cathode) placed on the scalp to target the cerebral cortex.
In patients with chronic pain, the anode is commonly placed over the motor cortex (M1) (Valeriani et al., 1999).
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain during intercourse (Numeric rating scale)
大体时间：Change in the NRS scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
Pain during intercourse will be assessed using a numeric rating scale (NRS) ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
This method for measuring pain has been shown to detect significant treatment effects in women with PVD and demonstrates a significant positive correlation with other pain intensity measures.
Pain during intercourse is the main symptom of PVD and the one that most interferes with quality of life, hence the most relevant measure of functional outcome (Bergeron et al., 2008; Bergeron et al., 2001; Morin et al., 2010; Morin et al., 2011).
|
Change in the NRS scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain (McGill-Melzack questionnaire)
大体时间：Change in the McGill-Melzack scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
The McGill-Melzack questionnaire allows the assessment of sensory, affective and evaluative components of pain.
This world-renowned questionnaire, studied for its validity, reliability and responsiveness to change, is commonly used in RCTs (Bergeron et al., 2001; Melzack, 1975; Davidoff et al., 1987; Hays et al., 1994; Bansal et al., 2009; Moy et al., 2011; Foster et al., 2010).
|
Change in the McGill-Melzack scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
|
Vestibular sensitivity (algometer)
大体时间：Change in the pain threshold and pain tolerance scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
A gradual pressure (1 to 1000 g) will be applied to three distinct points of the vestibule at the 3, 6 and 9 o'clock positions (Cyr et al., 2014).
Each of these pressure points will be applied randomly (e.g.
3,6,9 or 3,9,6 or 6,9,3.).
During this procedure, each participant will be asked to indicate when they start to feel pain (pain threshold) and subsequently the maximal pressure that can be tolerated (pain tolerance).
Pain intensity is assessed throughout the test using a Computerized Visual analog scale (CoVas).
This assessment has shown good reliability and validity (Cyr et al., 2014).
|
Change in the pain threshold and pain tolerance scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
|
Female Sexual Function Index (FSFI)
大体时间：Change in the FSFI scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
The Female Sexual Function Index (FSFI) is a multidimensional measure of sexual function evaluating desire, arousal, lubrication, orgasm, satisfaction and pain.
In addition to good psychometric properties (reliability, internal consistency and responsiveness to change (Rosen et al., 2000; Goldfinger et al, 2009), normative data are available for this questionnaire suggesting clinical level of dysfunctions (Wiegel et al., 2005).
|
Change in the FSFI scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
|
Pain Catastrophizing Scale (PCS)
大体时间：Change in the PCS scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995), which consists of 13 items measuring exaggerated negative thoughts and feelings about the meaning of pain.
Items are scored on a 5-point scale with the end points (0) not at all and (4) all the time.
The PCS is a reliable and valid measure that has demonstrated a stable factorial structure across clinical and general populations, including a French population (French et al., 2005; Osman et al., 2000; Sullivan, et al., 1995).
|
Change in the PCS scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
|
Spielberg State-Trait Anxiety Inventory (IASTA)
大体时间：Change in the IASTA state and IASTA trait scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
Anxiety will be assessed using the Spielberger State-Trait Anxiety Inventory (STAI - (Spielberger, Gorsuch, & Lushene, 1970); ASTA - (Gauthier & Bouchard, 1993)).
The STAI is a 40-item, well-known and widely used measure of state and trait anxiety that has demonstrated very good psychometric properties (Cronbach's alpha State = .93,
Trait = .97)
in various clinical and non-clinical samples including pain populations (Gauthier & Bouchard, 1993; Greenberg & Burns, 2003; Rule & Traver, 1983; Tanaka-Masumi & Kameoka, 1986).
|
Change in the IASTA state and IASTA trait scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
|
Beck Depression Inventory questionnaire (BDI-II)
大体时间：Change in the BDI scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
Depression or depression symptoms will be measured with the Beck Depression Inventory-II (BDI-II).
The BDI-II is comprised of 21 items, with scores for most items ranging from 0 (low intensity) to 3 (high intensity) (Beck, Steer & Brown, 1996; Beck, Steer & Garvin, 1988).
This measure of depression has been validated for use in chronic pain populations (Turner & Romano, 1984).
|
Change in the BDI scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
|
Pain Anxiety Symptoms Scale (PASS-20)
大体时间：Change in the PASS-20 scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
The Pain Anxiety Symptoms Scale (PASS-20), evaluating fear of pain, also shows good psychometric properties (Coons, Hadjistavropoulos & Asmundson, 2004; McCracken & Dhingra, 2002).
|
Change in the PASS-20 scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
|
Patient's global impression of change (PGIC)
大体时间：Change in the PGIC scores from 2-week post-treatment to 3-month post-treatment
|
Patient self-reported improvement [scale of 0 (completely dissatisfied) to 10 (completely satisfied)] and treatment satisfaction [scale of 0 (worse) to 10 (complete cure)] will be measured at the 2-week post-treatment and 3-month post-treatment structured interview in order to assess the clinical significance of results.
|
Change in the PGIC scores from 2-week post-treatment to 3-month post-treatment
|
|
Global Measure of Sexual Satisfaction scale (GMSS)
大体时间：Change in the GMSS scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
Sexual satisfaction will be assessed using the Global Measure of Sexual Satisfaction scale, which consists of 5 items assessing global sexual satisfaction.
Internal consistency of this scale is high (alpha = 0.90), as is test-retest reliability (r = 0.84) (Lawrance & Byers, 1998).
|
Change in the GMSS scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年11月1日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年11月1日
研究注册日期
首次提交
2015年9月4日
首先提交符合 QC 标准的
2015年9月4日
首次发布 (估计)
2015年9月7日
研究记录更新
最后更新发布 (实际的)
2017年5月2日
上次提交的符合 QC 标准的更新
2017年5月1日
最后验证
2017年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Active tDCS or Sham tDCS的临床试验
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of Waterloo招聘中
-
I.R.C.C.S. Fondazione Santa LuciaCampus Bio-Medico University完全的
-
Soterix MedicalGeorgetown University; National Institute of Neurological Disorders and Stroke (NINDS); University... 和其他合作者完全的