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

NCT02356796 | Completed

• 1 other identifier: 2014/1398 (REK)
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvis Pain Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in subjective health complaints

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

• Changes in fear of movement,

  From baseline to 12 months after start of intervention

• Changes in sexual function concerning pain during intercourse

  From baseline to 12 months after start of intervention

• Changes in general health condition

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

• Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation

  From baseline to 12 months

Study Arms (2)

Multidisciplinary group treatment

EXPERIMENTAL

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

Standard physiotherapy treatment

ACTIVE COMPARATOR

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

Interventions

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.

Multidisciplinary group treatment

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.

Standard physiotherapy treatment

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic pelvic pain lasting minimum 6 months
• Motivated for group intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Royal Norwegian Ministry of Health: collaborator
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator
• University of Tromso: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Study Officials

• Paal Oian, Professor MD

  University Hospital of North Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 5, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

NO (1)