Prospective Observational Study That Evaluates Predictor Tests for the Success of Myofascial Pelvic Floor Muscles for the Treatment of PBS
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Reduction of pain level
研究概览
简要总结
Study aims to: (1) evaluate the role of morphological and physiological characteristics of the pelvic floor, pain-related psychological and -psychophysical variables in prediction of the success of myofascial physical therapy (MPT) for the treatment of painful bladder syndrome Patients with clinical symptoms of PBS will undergo physical examination, sensory testing in the genital area, perineal ultrasound examination for the evaluation of the length of the levator muscles before MPT and following 10 consecutive sessions of MPT.
Improvement in clinical symptoms will be assessed and evaluated for correlations with psychophysical examinations.
详细描述
Background: Chronic pelvic pain syndrome (CPPS) is highly prevalent, yet its etiology and the treatment approach are not clear. Painful bladder syndrome (PBS), a subtype of CPPS, is commonly treated by Myofascial physical therapy (MPT), however its efficiency is limited to portion of patients. The relative contribution of local factors such as pelvic anatomical and physiological function compared with systemic pain- related psychological and psychophysical parameters in the prediction of MPT outcome has not been illumined yet.
Hypothesis and aims: Assuming that MPT has mainly local effect its treatment success can be predicted by local impairment of pelvic anatomical and physiological function assessed pretreatment.
Study aims to: (1) evaluate the role of morphological and physiological characteristics of the pelvic floor, pain-related psychological and -psychophysical variables in prediction of MPT success, (2) to assess the effect of MPT on these parameters.
Methods: PBS patients will be evaluated for symptoms severity prior to MPT by: (1) pelvic physical examination for identification of trigger points, (2) self-report of pelvic pain intensity on visual analogue scale (VAS), (3) filling a questionnaire for urinary urgency symptoms, (4) evaluation of morphological and physiological characters of pelvic muscles floor by ultrasound and Doppler, respectively, (5) assessment of pain-related psychological variables (depression, somatization and pain catastrophizing) by questionnaires, and (6) psychophysical tests of experimental pain perception. Following 3 months treatment of MPT, patients will be reevaluated for the same tests. Treatment success will be determined by 30% reduction in pain and urinary urgency.
Expected results: Patients with shorter levator muscles and reduced blood flow in the pelvic region will benefit from MPT compared to patients with augmented pain sensitivity and higher depression, pain catastrophizing and somatization scores. MPT will elongate levator muscles and increased blood flow to the pelvic region that will be associated with the improvement in PBS symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 18 years old
- •urinary frequency of at least 10 per 24 hr including one nighttime voiding
- •complaints of bladder pain that has been present for at least 3 months
- •pain intensity rated at least four on a VAS from 0 ''no pain at all'' to 10 ''worst imaginable pain'' during the previous month
- •pelvic digital exam reveals at least three different TrPs in the levator ani muscles that are verbally confirmed.
- •Exclusion criteria:
- •history of pelvic cancer or radiation
- •pelvic or abdominal surgery within 3 months
- •urinary tract infection within the last month
- •diagnosis of fibromyalgia or irritable bowel disease
- •diagnosis of neurologic disorder; diabetes; pregnancy;
- •pelvic pain and/ or urgency symptoms presented only during menses.
排除标准
- 未提供
结局指标
主要结局
Reduction of pain level
时间窗: 3 months
Following MPT it is expected that patients PBS symptoms will be improved as will be evaluated by VAS.
次要结局
- Elongation of levator ani muscles.(3 months)