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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Troms
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Tromso, Troms, Noorwegen, 9038
- University Hospital of North Norway
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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. |
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. |
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Actieve vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in pelvic pain
Tijdsspanne: From baseline to 3, 6 and 12 months after start of intervention.
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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).
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From baseline to 3, 6 and 12 months after start of intervention.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in subjective health complaints
Tijdsspanne: From baseline to 3, 6 and 12 months after start of intervention
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Self reported health complaints last 30 days, using a standardized questionnaire.
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From baseline to 3, 6 and 12 months after start of intervention
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Changes in fear of movement,
Tijdsspanne: From baseline to 12 months after start of intervention
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Measured with Tampa Scale of Kinesiophobia, a self-completed questionnaire.
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From baseline to 12 months after start of intervention
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Changes in sexual function concerning pain during intercourse
Tijdsspanne: From baseline to 12 months after start of intervention
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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".
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From baseline to 12 months after start of intervention
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Changes in general health condition
Tijdsspanne: From baseline to 3, 6 and 12 months after start of intervention
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EQ-5D questionnaire recording mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
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From baseline to 3, 6 and 12 months after start of intervention
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Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation
Tijdsspanne: From baseline to 12 months
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Measured by the standardized St.Marks score, the ICIQ-UI_SF and the Obstructed Defecation Syndrome Score.
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From baseline to 12 months
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Changes in motor functions: posture, movement, gait, sitting posture, respiration
Tijdsspanne: From baseline to 12 months after start of intervention
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A standardized Mensendieck test is used.
Motor functions are recorded and evaluated by a trained physiotherapist.
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From baseline to 12 months after start of intervention
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Paal Oian, Professor MD, University Hospital of North Norway
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2014/1398 (REK)
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