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

Chronic Pelvic Pain in Women - Conservative Multidisciplinary Group Treatment Compared to Standard Conservative Treatment. A Randomised Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Pelvis Pain Chronic
• Intervention / Treatment: Other: Multidisciplinary group treatment; Other: Standard physiotherapy treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Troms
    • Tromso, Troms, Norway, 9038
      • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pelvic pain	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).	From baseline to 3, 6 and 12 months after start of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in subjective health complaints	Self reported health complaints last 30 days, using a standardized questionnaire.	From baseline to 3, 6 and 12 months after start of intervention
Changes in fear of movement,	Measured with Tampa Scale of Kinesiophobia, a self-completed questionnaire.	From baseline to 12 months after start of intervention
Changes in sexual function concerning pain during intercourse	Questionnaire recording sexual desire, orgasm problems and pain during intercourse. Each item is scored "all the time", "almost all the time", "often", "rarely" or "never".	From baseline to 12 months after start of intervention
Changes in general health condition	EQ-5D questionnaire recording mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	From baseline to 3, 6 and 12 months after start of intervention
Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation	Measured by the standardized St.Marks score, the ICIQ-UI_SF and the Obstructed Defecation Syndrome Score.	From baseline to 12 months
Changes in motor functions: posture, movement, gait, sitting posture, respiration	A standardized Mensendieck test is used. Motor functions are recorded and evaluated by a trained physiotherapist.	From baseline to 12 months after start of intervention

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: University of Tromso; The Royal Norwegian Ministry of Health; Norwegian Fund for Postgraduate Training in Physiotherapy
• Investigators: Study Chair: Paal Oian, Professor MD, University Hospital of North Norway

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: 2014/1398 (REK)