Chronic Pelvic Pain in Women - Conservative Group Treatment Compared to Standard Conservative Treatment. (CPP)

University Hospital of North Norway

Status: Completed

Conditions: Pelvis Pain Chronic

Treatments: Other: Standard physiotherapy treatment; Other: Multidisciplinary group treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02356796

2014/1398 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

62 participants in 2 patient groups

Multidisciplinary group treatment

Experimental group

Description:

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.

Treatment:

Other: Multidisciplinary group treatment

Standard physiotherapy treatment

Active Comparator group

Description:

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.

Treatment:

Other: Standard physiotherapy treatment