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Completed

NCT Number: NCT02356796

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

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.

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Key information

Conditions

Pelvis Pain Chronic

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidisciplinary group treatment

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

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.

Primary outcomes

  1. 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

  1. Changes in subjective health complaints

    Time frame: From baseline to 3, 6 and 12 months after start of intervention

    Self reported health complaints last 30 days, using a standardized questionnaire.

  2. Changes in fear of movement,

    Time frame: From baseline to 12 months after start of intervention

    Measured with Tampa Scale of Kinesiophobia, a self-completed questionnaire.

  3. Changes in sexual function concerning pain during intercourse

    Time frame: From baseline to 12 months after start of intervention

    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".

  4. Changes in general health condition

    Time frame: From baseline to 3, 6 and 12 months after start of intervention

    EQ-5D questionnaire recording mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  5. Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation

    Time frame: From baseline to 12 months

    Measured by the standardized St.Marks score, the ICIQ-UI_SF and the Obstructed Defecation Syndrome Score.

  6. Changes in motor functions: posture, movement, gait, sitting posture, respiration

    Time frame: From baseline to 12 months after start of intervention

    A standardized Mensendieck test is used. Motor functions are recorded and evaluated by a trained physiotherapist.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • The Royal Norwegian Ministry of Health
  • University of Tromso

Registry information

Official study title

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

Acronym: CPP

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2015
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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