Efficacy of High Intensity Laser Therapy for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 8
- 主要终点
- Change in pain intensity during intercourse
研究概览
简要总结
This is a multicenter randomized controlled trial (RCT) investigating the effects of laser treatments in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses. Eligible participants will then be asked to complete a consent form and the baseline assessment. The baseline assessment consists of the completion of validated questionnaires (outcome measures). Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of active high intensity laser therapy (HILT) (30 minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30 minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcome measures (validated questionnaires) will also be assessed 2 weeks post-treatment as well as 6 months post-treatment (follow-up assessment).
详细描述
Vulvodynia, a chronic vulvar pain condition, affects between 8 and 18% of reproductive-aged women. The main subtype of vulvodynia is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening while applying pressure to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD experience greater psychological distress, a worsened quality of life and overall well-being as well as sexual dysfunctions for both the women and their intimate partners. Women suffering from PVD have limited treatment options, and some women have persistent pain despite the available treatment options. Therefore, a new therapeutic avenue needs to be explored. High intensity laser therapy (HILT), a non-invasive and non-ablative laser technique, was found to be effective in several chronic pain conditions. Our randomized pilot study confirmed that HILT is feasible for treating PVD. The promising findings obtained provided support for conducting this large multicenter randomized controlled 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)
盲法说明
Participants, investigators, outcomes assessors and data analysts will be masked to group assignation.
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
- •Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourse or attempted sexual intercourse for at least 3 months
- •Provoked vestibulodynia of at least 3 months duration prior to the study and diagnosed by a standardized gynaecologic exam
排除标准
- •Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvovaginal atrophy)
- •Post-menopausal state
- •Current pregnancy or pregnancy in the last year
- •Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
- •Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organ prolapse surgery)
- •Prior use of laser treatments for vulvar pain
- •Expected changes of medication that could influence pain perception (e.g., analgesic, antidepressant)
- •Other medical conditions that could interfere with the study
研究组 & 干预措施
High Intensity Laser Therapy (HILT)
Active high intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
干预措施: High Intensity Laser Therapy (HILT) (Radiation)
Sham High Intensity Laser Therapy
Sham high-intensity laser therapy for 12 biweekly sessions (6 consecutive weeks of biweekly treatments)
干预措施: Sham High Intensity Laser Therapy (Radiation)
结局指标
主要结局
Change in pain intensity during intercourse
时间窗: Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment
To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever)
次要结局
- Change in pain quality(Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment)
- Change in the life impact of pelvic pain(Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment)
- Level of satisfaction with treatment(2-week post-treatment evaluation, 6-months follow-up assessment)
- Patient's global impression of change(2-week post-treatment evaluation, 6-months follow-up assessment)
- Change in sexual distress(Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment)
- Change in fear of pain(Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment)
- Change in pain catastrophizing(Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment)
- Change in sexual function(Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment)
- Change in intercourse self-efficacy(Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment)
- Change in cognitions regarding vaginal penetration(Baseline, 2-week post-treatment evaluation, 6-months follow-up assessment)