Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain
研究概览
简要总结
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain.
详细描述
It is evident that physiotherapeutic techniques and pain education are a first-line treatment for patients suffering from chronic pelvic pain. But there is no scientific evidence that resistive capacitive monopolar radiofrequency can be another treatment option for these patients, although at the clinical level there is evidence of its beneficial effects.
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, Care Provider, Investigator)
盲法说明
Triple blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an age equal to or greater than 18 years
- •Having chronic pelvic pain of six or more months of evolution.
排除标准
- •Failure to grant informed consent.
- •Have fibromyalgia.
- •Present a pacemaker or other type of electronic implant.
- •Suffer systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
- •Previous treatment with chemotherapy and / or radiotherapy in the pelvic area.
- •Suffering from neuromuscular diseases (amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis or spinal muscular atrophy).
- •Have myelopathy and osteomyelitis.
- •Have neurological and / or metabolic pathology that alters the response capacity: diabetes, parkinson's disease, senile dementia ...
- •Have an alteration of the central nervous system (traumatic or spinal vascular injury)
- •Suffer oncological processes with sacral involvement.
- •Have a severe mental disorder.
- •Have vulvodynia
- •Be pregnant.
- •Have undergone surgery in the last 3 months in the pelvic area.
- •Have hypersensitivity of the skin, hyposensitivity and / or rejection of manual contact.
- •Inability to correctly complete the questionnaires or understand the study protocol.
- •Having initiated other pelvic physiotherapy treatments during the study intervention.
结局指标
主要结局
Efficacy of resistive capacitive monopolar radiofrequency in the modification of the perception of pain
时间窗: baseline and 10 weeks
The objective is to assess if there is a change in the perception of pain intensity according to VAS (Visual Analog Scale). Compare baseline and at the end of the intervention. The Visual Analog Scale is a validated questionnaire that scores between 0 and 10 the perception of pain that the patient has. In a line of 10 cm the patient will mark his intensity of the pain taking into account that 0 means "I have no pain" and 10 means "I have an unbearable pain". The Visual Analog Scale (VAS) suitably collects the pain intensity perceived by the patient and allows to assess the severity of the disease, as well as the improvement obtained with the treatment.
次要结局
- Assess kinesiophobia(baseline, 5 and 10 weeks)
- Assess catastrophism(baseline, 5 and 10 weeks)
- Assess number of participants with high adherence to treatment(10 weeks)
- Assess quality of life(baseline, 5 and 10 weeks)
- Assess the degree of adherence to treatment(10 weeks)
- Assess number of participants with adverse effects(10 weeks)
研究者
Andrea Carralero Martínez
Physical therapist
RAPbarcelona