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

Primary Purpose

Pelvis Pain Chronic

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Multidisciplinary group treatment
Standard physiotherapy treatment
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvis Pain Chronic

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multidisciplinary group treatment

Standard physiotherapy treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Changes in subjective health complaints
Self reported health complaints last 30 days, using a standardized questionnaire.
Changes in fear of movement,
Measured with Tampa Scale of Kinesiophobia, a self-completed questionnaire.
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".
Changes in general health condition
EQ-5D questionnaire recording mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
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.
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.

Full Information

First Posted
February 2, 2015
Last Updated
May 2, 2018
Sponsor
University Hospital of North Norway
Collaborators
The Royal Norwegian Ministry of Health, Norwegian Fund for Postgraduate Training in Physiotherapy, University of Tromso
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1. Study Identification

Unique Protocol Identification Number
NCT02356796
Brief Title
Chronic Pelvic Pain in Women - Conservative Group Treatment Compared to Standard Conservative Treatment.
Acronym
CPP
Official Title
Chronic Pelvic Pain in Women - Conservative Multidisciplinary Group Treatment Compared to Standard Conservative Treatment. A Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
The Royal Norwegian Ministry of Health, Norwegian Fund for Postgraduate Training in Physiotherapy, University of Tromso

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvis Pain Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinary group treatment
Arm Type
Experimental
Arm 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.
Arm Title
Standard physiotherapy treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary group treatment
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Standard physiotherapy treatment
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in pelvic pain
Description
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).
Time Frame
From baseline to 3, 6 and 12 months after start of intervention.
Secondary Outcome Measure Information:
Title
Changes in subjective health complaints
Description
Self reported health complaints last 30 days, using a standardized questionnaire.
Time Frame
From baseline to 3, 6 and 12 months after start of intervention
Title
Changes in fear of movement,
Description
Measured with Tampa Scale of Kinesiophobia, a self-completed questionnaire.
Time Frame
From baseline to 12 months after start of intervention
Title
Changes in sexual function concerning pain during intercourse
Description
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".
Time Frame
From baseline to 12 months after start of intervention
Title
Changes in general health condition
Description
EQ-5D questionnaire recording mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time Frame
From baseline to 3, 6 and 12 months after start of intervention
Title
Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation
Description
Measured by the standardized St.Marks score, the ICIQ-UI_SF and the Obstructed Defecation Syndrome Score.
Time Frame
From baseline to 12 months
Title
Changes in motor functions: posture, movement, gait, sitting posture, respiration
Description
A standardized Mensendieck test is used. Motor functions are recorded and evaluated by a trained physiotherapist.
Time Frame
From baseline to 12 months after start of intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paal Oian, Professor MD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromso
State/Province
Troms
ZIP/Postal Code
9038
Country
Norway

12. IPD Sharing Statement

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

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