Chronic Pelvic Pain in Women - Conservative Multidisciplinary Group Treatment Compared to Standard Conservative Treatment. A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Changes in pelvic pain
研究概览
简要总结
The purpose of this study is to evaluate the effect of a multidisciplinary group based treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The hypothesis is that multidisciplinary group based treatment is more effective than standard physiotherapy for women with CPP. The participants will be randomized to one of two treatment arms, and the treatment effect will be evaluated 12 months after start of intervention.
详细描述
Background: Chronic pelvic pain (CPP) is a common source of pain and reduced quality of life among women throughout the world. CPP is a complex condition, and the understanding of both etiology and effective treatment is limited. The newest/latest clinical guidelines recommend a holistic and multidisciplinary treatment approach to this condition.
In accordance with the guidelines a multidisciplinary group based treatment for women with CPP has been started at the University Hospital of North Norway. The treatment is offered to patients who are considered to benefit from conservative treatment approach.
Method: To investigate the effect of a group based treatment compared to standard conservative treatment by physiotherapists in primary or secondary health care, a randomized controlled trial will be conducted.
Patients who are found eligible and consent to participate in the trial, will be randomized to one of the two treatment options. Data will be registered at baseline, 3, 6 and 12 months after start of treatment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chronic pelvic pain lasting minimum 6 months
- •Motivated for group intervention
排除标准
- •Pelvic pathology that needs medical treatment other than conservative
- •Pregnancy, or labour last 12 months.
- •Abdominal or pelvic surgery the last 6 months
- •Botox injections in pelvic areas last 4 months.
- •Drug addiction or using large dozes of analgesics
- •Serious psychiatric diagnosis. Consent capability is necessary.
- •Not speaking/writing Norwegian language
- •Previously treated by physiotherapist involved in the group intervention in this project
研究组 & 干预措施
Multidisciplinary group treatment
Multidisciplinary group intervention at the University Hospital of North Norway. The group intervention is led by physiotherapists, with contributions from a gynecologist, nutritionist and a peer patient. The treatment consists of active exercises and theory lessons. The focus is to enhance the participants body awareness and to recognize the integration of mental and physical processes. The aim is to create change in patterns that influence the participants health negatively.
The treatment lasts one year. The first meeting has a duration of 10 days, then follow-up after 3, 6 and 12 months.
干预措施: Multidisciplinary group treatment (Other)
Standard physiotherapy treatment
Standard treatment in primary or secondary health care physiotherapy. Patients are referred to a physiotherapist with appropriate training/competence, as close to their home as possible.
干预措施: Standard physiotherapy treatment (Other)
结局指标
主要结局
Changes in pelvic pain
时间窗: From baseline to 3, 6 and 12 months after start of intervention.
Self reported pelvic pain the last 7 days. The worst, the least and the mean pain are recorded. Each item is scored 0-10 (0=no pain, 10 = pain as bad as can be).
次要结局
- Changes in general health condition(From baseline to 3, 6 and 12 months after start of intervention)
- Changes in motor functions: posture, movement, gait, sitting posture, respiration(From baseline to 12 months after start of intervention)
- Changes in sexual function concerning pain during intercourse(From baseline to 12 months after start of intervention)
- Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation(From baseline to 12 months)
- Changes in subjective health complaints(From baseline to 3, 6 and 12 months after start of intervention)
- Changes in fear of movement,(From baseline to 12 months after start of intervention)