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

NCT ID: NCT02356796

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-01-31

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.

Conditions

Pelvis Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multidisciplinary group treatment

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard physiotherapy treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Royal Norwegian Ministry of Health

OTHER

Sponsor Role: collaborator

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paal Oian, Professor MD

Role: STUDY_CHAIR

University Hospital of North Norway

Locations

University Hospital of North Norway

Tromsø, Troms, Norway

Countries

Norway

Other Identifiers

2014/1398 (REK)

Identifier Type: -

Identifier Source: org_study_id