Dry Needling for Women With Provoked Vestibulodynia: A Feasibility and Acceptability Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Adherence to treatment sessions
研究概览
简要总结
This is a randomized and controlled study investigating the feasibility and acceptability of a dry needling treatment for women suffering from provoked vestibulodynia. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses of provoked vestibulodynia. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. The sham group will receive 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain intensity and quality, pain during palpation and pressure pain threshold, psychosexual variables, perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness and function.
详细描述
Up to 18% of reproductive-aged women experience chronic pain in the vulvar region during sexual intercourse. This chronic pain condition is called vulvodynia. The main subtype of this pain condition is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening when there is a pressure applied to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD suffer from sexual dysfunctions, psychological distress and worsened quality of life. The treatment options currently available are still quite limited and some women still experience pain despite undertaking all options available. We, therefore, proposed a randomized and controlled study to investigate the feasibility and acceptability of a dry needling treatment for women suffering from PVD. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. Participants and evaluators will be blinded. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. For the first three sessions, the dry needling/or sham techniques will be aimed at the muscles of the trunk, lower back, hips and SI joints. For the last 3 treatment sessions, the dry needling/or sham techniques will aimed at the pelvic floor muscles. The sham group will receive the same 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and 2 weeks post-treatment and will include: feasibility (adherence to treatment, retention rates, adverse effects, recruitment rates and data on dry needling (needles, # of insertions, pain related) and acceptability variables. Secondary outcomes will include pain intensity during intercourse (numeric scale) and quality (McGill pain questionnaire), pain during palpation and pressure pain threshold (Pressure algometer), psychosexual variables (sexual distress and sexual function), change in pain catastrophizing, change in quality of life in domains associated with chronic pelvic pain (Pelvic Pain Impact questionnaire, severity of symptoms related to central sensitization), perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness (shearwave elastography and dynamometric speculum)and function (dynamometric speculum), blinding efficacy.
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 standardised gynaecologic exam
- •Moderate to severe pain (≥ 5/10) in at least 90% of sexual intercourses or attempted sexual intercourse 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)
- •Post-menopausal state
- •Actual or past pregnancy in the last year
- •Urogynecological conditions (e.g., pelvic organs prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
- •Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organs prolapse surgery)
- •Prior use of dry needling or acupuncture treatments
- •Fear of needles or any contraindication to needling therapies
- •Changes of medication that could influence pain perception (e.g., analgesic, antidepressant) in the last 3 months
- •Other medical conditions that could interfere with the study
研究组 & 干预措施
Experimental: Real Dry needling
1 dry needling treatment per week for 6 consecutive weeks
干预措施: Real Dry needling (Other)
Sham: Non penetrating dry needling
1 non penetrating dry needling per week for 6 consecutive weeks
干预措施: Non penetrating dry needling (Other)
结局指标
主要结局
Adherence to treatment sessions
时间窗: Through treatment completion (session 1 to 6; 6 weeks of treatment)
a. To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Adherence to treatment protocol
时间窗: Through treatment completion (session 1 to 6; 6 weeks of treatment)
a. To determine feasibility by assessing adherence to treatment sessions.
Adverse effects
时间窗: Post-treatment assessment (2-week post-treatment)
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Retention rate
时间窗: Baseline to Post-treatment assessment (2-week post-treatment)
a. To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled
Intervention Acceptability Questionnaire
时间窗: Post-treatment assessment (2-week post-treatment)
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Recruitment rate
时间窗: Baseline
a. To determine feasibility by assessing the percentage of participants included versus the participants screened. The barriers and reasons for refusing to participate as well as the reasons for exclusion will be documented
次要结局
- Change in pain quality(Baseline to Post-treatment assessment (2-week post-treatment))
- Patient's global impression of change(Post-treatment assessment (2-week post-treatment))
- Changes in pelvic floor muscle function(Baseline to Post-treatment assessment (2-week post-treatment))
- Changes in pressure pain threshold(Baseline to Post-treatment assessment (2-week post-treatment))
- Change in pain catastrophizing(Baseline to Post-treatment assessment (2-week post-treatment))
- Change in sexual distress(Baseline to Post-treatment assessment (2-week post-treatment))
- Severity of symptoms related with central sensitization(Baseline to Post-treatment assessement (2-week post-treatment))
- Changes in pelvic floor muscle stiffness(Baseline to Post-treatment assessment (2-week post-treatment))
- Change in sexual function(Baseline to Post-treatment assessment (2-week post-treatment))
- Blinding effectiveness(Post-treatment assessment (2-week post-treatment))
- Change in pain intensity during intercourse(Baseline to Post-treatment assessment (2-week post-treatment))
- Change in fear of pain(Baseline to Post-treatment assessment (2-week post-treatment))
- Change in quality of life in the domains associated with chronic pelvic pain(Baseline to Post-treatment assessment (2-week post-treatment))
- Satisfaction with treatment(Post-treatment assessment (2-week post-treatment))
- Changes in pain at palpation(Baseline to Post-treatment assessment (2-week post-treatment))
研究者
Mélanie Morin
Principal investigator, professor and researcher, director of the research laboratory in urogynecology
Université de Sherbrooke