Effect of Radiofrequency in Women With Chronic Pelvic Pain With an Associated Myofascial Syndrome Versus Myofascial Therapy and no Treatment: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Level
研究概览
简要总结
A randomised clinical trial is being conducted in the Gynecology Department of the Hospital Clinic de Barcelona in women presenting chronic pelvic pain syndrome due to a myofascial cause which is over a 4 score in the VAS scale and not related to an obstetric injury. This study presents 4 groups; two groups receive 8 radiofrequency sessions, one group receives 8 sessions of myofascial release therapy (MRT) and the last group receives no treatment at all (NT). The two RF groups have been divided into a RF intervention group (RFIG) and a RF control group (RFCG) which receives sham treatment. The RF groups are double-blinded. Other than RF, both groups perform daily Thiele massage at home. The sessions last for 20 minutes and take place once a week during 8 weeks.
The main variable evaluated is the level of pain during the muscular assessment carried out by an expert pelvic floor physical therapist using the Verbal numeric Scale in the first session and at the end of the 8 sessions. Secondary variables are: sexual function (throughout FSFI questionnaire), pain catastrophizing (ECD), quality of life (EQ5D), anxiety and depression (HADS), central sensitization (CSI) as well as other pelvic floor dysfunction symptoms (PFDI).
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
- Double (Participant, 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
- •included women who were:
- •At least 18 years of age
- •Presenting with pelvic pain persisting for at least 6 months
- •Diagnosed with myofascial syndrome of the pelvic floor muscles (PFM) by a specialist based on physical assessment
- •Presenting with pelvic pain intensity greater than 4 on the Visual Analog Scale (VAS) in the last 3 months
- •Agreed to sign the informed consent form.
排除标准
- •included the following:
- •Patients who were pregnant
- •Postpartum patients who had given birth within the last year
- •Patients with a history of vulvovaginal pathology
- •Contraindications for the use of radiofrequency: metal implants or active infection
- •Patients with a history of pelvic cancer, including those who had undergone chemotherapy, radiotherapy, and/or brachytherapy.
研究组 & 干预措施
ON RF
Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the intervention group 1 will receive treatment with activated RF, with the electrode at a medium intensity for 20 minutes per session during a total of 8 sessions, held weekly.
干预措施: Radiofrequency therapy (Device)
MYOFASCIAL MANUAL THERAPY
Application of the technique in the intervention group 2 (MYOFASCIAL MANUAL THERAPY): the intervention group 2 will receive treatment for 20 minutes per session during a total of 8 sessions, held weekly.
干预措施: myofascial manual therapy (Other)
OFF RF
Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the CONTROL group 2 will receive treatment with activated RF, with the electrode for 20 minutes per session during a total of 8 sessions, held weekly.
干预措施: Radiofrequency therapy (Device)
NO TREATMENT
Patients in waiting list, pending treatment will not receive treatment but symptoms will be monitored after 6 months
结局指标
主要结局
Pain Level
时间窗: 8 weeks
Pain Level using the Verbal Numeric Scale (VNS). The scores go from 0 (lowest) to 10 (highest)
次要结局
- Sexual function(8 weeks)
- Quality of life (QoL)(8 weeks)
- Pain catastrophizing(8 weeks)
- Anxiety and depression(8 weeks)
- Central sensitization(8 weeks)
研究者
Carla Box
Principal Investigator
Hospital Clinic of Barcelona