Physical Therapy as Adjuvant Treatment of Vulvodynia: a Randomized Controled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Pain Scale Measurement
研究概览
简要总结
INTRODUCTION: Vulvodynia (chronic vulvar pain in the absence of clinical findings) has a negative impact over quality of life in women with this diagnose. The existing treatments, however, are manifold but insufficient. This study aims to verify the effectiveness of kinesiotherapy and electrotherapy as adjuvant methods in the treatment of vulvodynia. METHODS: A single-blind randomized controlled trial will examine 58 women, divided into three treatment arms: use of tricyclic antidepressant alone (hydrochloride Amitriptyline), amitriptyline hydrochloride associated with pelvic floor muscle exercises and amitriptyline hydrochloride associated with electrotherapy (interferential current). Exclusion criteria are: presence of infections or genital cancers, chronic degenerative diseases; younger than 18 years, neurological disease that jeopardizes the contraction of the muscles of the pelvic floor, taking antidepressant drugs that have interaction with amitriptyline hydrochloride and being pacemakers use. The parameters analyzed before and after treatment will be: muscle volume of the anus elevator and perfusion of the pudendal artery obtained with 3D ultrasound, subjective pain in vaginal intercourse (visual analog scale), monthly frequency of vaginal intercourse, pain referred within vulvar touch on physical examination (swab test from zero to 10) and female sexual function (Female Sexual Function questionnaire - FSFI). There will be a follow up of subjective pain in vaginal intercourse and monthly frequency of vaginal intercourse obtained by telephone contact with the voluntary on one, six and twelve months after the end of interventions. The data will be analyzed using Chi-square test of Pearson, Fisher exact and Mann-Whitney. The beginning and end of treatment will be compared using the Wilcoxon test (related samples) and McNemar (effect of the intervention), considering statistical significance level of 5%. The software used is the statistical analysis software (SAS) - Release 9.1, SAS Institute, Cary, North Carolina, USA, 2002-2003 and Statistical Package for the Social Sciences (SPSS) -Release 17.0.
详细描述
GOALS
- General Check the effectiveness of physical therapy applied to the pelvic floor muscles used as an adjunct to standard treatment (amitriptyline hydrochloride) on the improvement of symptoms of vulvodynia.
- Specific
Check and compare in women with vulvodynia before and after being randomly assigned to three treatment arms (drug only drug associated with therapeutic exercise or medication associated with electrotherapy with CI):
- Pain during intercourse and during the swab test obtained by Visual Analogue Scale (VAS);
- The scores obtained in the questionnaire Female Sexual Function Index (FSFI);
- The change in the volume of puborectal, pubococcygeus and iliococcygeal muscles accessed through Tridimensional Ultrasound (US3D);
- The variation of the perfusion of the pelvic floor muscles by pudendal artery obtained by 3D ultrasound;
- The effectiveness of therapeutic exercise in the improvement of vulvar pain to test swab and sexual intercourse by penetration in women diagnosed with vulvodynia;
- The effectiveness of electrical therapy with interferential current in the improvement of vulvar pain to test swab and sexual intercourse by penetration of women diagnosed with vulvodynia;
- Compare the effectiveness of electrical therapy and kinesiotherapy in the improvement of vulvar pain;
- Compare the effectiveness of physical therapy as an adjunct to standard against standard treatment alone.
SUBJECTS AND METHODS:
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having had previous vaginal penetration
- •Accept to perform kinesiotherapy sessions or electrical therapy once a week for two months
- •Accept using medication (Amitriptyline hydrochloride) during the treatment period
排除标准
- •Being pregnant
- •Using drugs that negatively interfere with the hydrochloride Amtriptilina (ANNEX II)
- •Having cognitive or literacy difficulties that prevent the understanding of self answered questionnaires such Female Sexual Function Index (FSFI).
- •Refusing to sign the Informed Consent
- •Neuromuscular disorders that interfere on the proper contraction of the pelvic floor muscles
- •Having decompensated chronic degenerative diseases (tuberculosis, AIDS, hepatitis, diabetes, etc.)
- •Using pacemaker or having cardiac arrhythmia
- •Taking antidepressant monoamine oxidase inhibitor (MAOI) or Ayahuasca tea
研究组 & 干预措施
Amitriptyline
This group will be treated with medication alone (amitriptyline hydrochloride, 25 mg) for chronic vulvar pain (vulvodynia).
干预措施: Amitriptyline (Drug)
Amitriptyline plus kinesiotherapy
This group will be treated with medication (amitriptyline hydrochloride, 25 mg) plus pelvic floor exercises such as Kegel contractions and stretching of pelvic floor muscles with patients own hands.
干预措施: Amitriptyline (Drug)
Amitriptyline plus kinesiotherapy
This group will be treated with medication (amitriptyline hydrochloride, 25 mg) plus pelvic floor exercises such as Kegel contractions and stretching of pelvic floor muscles with patients own hands.
干预措施: Kinesiotherapy (Other)
Amitriptyline plus IC (Quark)
This group will be treated with medication (amitriptyline hydrochloride, 25 mg) plus electrical stimulation with Interferential Current (manufacturer: Quark Medical; Model: Dualpex 961 - program number 42): two electrodes put into the perineal surface area emitting interferential current, once a week for twenty minutes each, for eight weeks long.
干预措施: Amitriptyline (Drug)
Amitriptyline plus IC (Quark)
This group will be treated with medication (amitriptyline hydrochloride, 25 mg) plus electrical stimulation with Interferential Current (manufacturer: Quark Medical; Model: Dualpex 961 - program number 42): two electrodes put into the perineal surface area emitting interferential current, once a week for twenty minutes each, for eight weeks long.
干预措施: IC (Quark) (Device)
结局指标
主要结局
Pain Scale Measurement
时间窗: Eight weeks
Effectiveness of the treatment for vulvodynia will be accessed through pain score scale from zero to ten, compared from day zero of treatment to day eight
次要结局
- Female Sexual Index Function Improvement(Eight weeks)
- 3D Ultrasound measurement of Pelvic Floor Muscle thickness and pudendal artery flow(Eight weeks)
研究者
Marcela Grigol Bardin
Master in Obstetrics and Gynecology
University of Campinas, Brazil