Clinical trial NCT02356796: Chronic Pelvic Pain in Women - Conservative Group Treatment Compared to Standard Conservative Treatment.
Official title: Chronic Pelvic Pain in Women - Conservative Multidisciplinary Group Treatment Compared to Standard Conservative Treatment. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvis Pain Chronic
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
name: Norwegian Fund for Postgraduate Training in Physiotherapy
name: University of Tromso
First posted: 2015-02-05
Enrollment: 62
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in pelvic pain
timeFrame: From baseline to 3, 6 and 12 months after start of intervention.
Secondary outcomes:
measure: Changes in subjective health complaints
timeFrame: From baseline to 3, 6 and 12 months after start of intervention
measure: Changes in fear of movement,
timeFrame: From baseline to 12 months after start of intervention
measure: Changes in sexual function concerning pain during intercourse
timeFrame: From baseline to 12 months after start of intervention
measure: Changes in general health condition
timeFrame: From baseline to 3, 6 and 12 months after start of intervention
measure: Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation
timeFrame: From baseline to 12 months
measure: Changes in motor functions: posture, movement, gait, sitting posture, respiration
timeFrame: From baseline to 12 months after start of intervention
Other outcomes:
Locations:
city: Tromso
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Paal Oian, Professor MD
role: STUDY_CHAIR
References: