Chronic Pelvic Pain in Women - Conservative Multidisciplinary Group Treatment Compared to Standard Conservative Treatment. A Randomised Controlled Trial.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pelvis Pain Chronic
- Sponsor
- University Hospital of North Norway
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Changes in pelvic pain
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic pelvic pain lasting minimum 6 months
- •Motivated for group intervention
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Changes in pelvic pain
Time Frame: 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).
Secondary Outcomes
- 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)