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

2. Mai 2018 aktualisiert von: University Hospital of North Norway

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

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

62

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Norwegen
    • Troms
      • Tromso, Troms, Norwegen, 9038
        • University Hospital of North Norway

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: 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.
Aktiver Komparator: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in pelvic pain
Zeitfenster: 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).
From baseline to 3, 6 and 12 months after start of intervention.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in subjective health complaints
Zeitfenster: From baseline to 3, 6 and 12 months after start of intervention
Self reported health complaints last 30 days, using a standardized questionnaire.
From baseline to 3, 6 and 12 months after start of intervention
Changes in fear of movement,
Zeitfenster: From baseline to 12 months after start of intervention
Measured with Tampa Scale of Kinesiophobia, a self-completed questionnaire.
From baseline to 12 months after start of intervention
Changes in sexual function concerning pain during intercourse
Zeitfenster: 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".
From baseline to 12 months after start of intervention
Changes in general health condition
Zeitfenster: 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.
From baseline to 3, 6 and 12 months after start of intervention
Changes in fecal incontinence, urinary incontinence (UI), obstructed defecation
Zeitfenster: From baseline to 12 months
Measured by the standardized St.Marks score, the ICIQ-UI_SF and the Obstructed Defecation Syndrome Score.
From baseline to 12 months
Changes in motor functions: posture, movement, gait, sitting posture, respiration
Zeitfenster: 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.
From baseline to 12 months after start of intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital of North Norway

Mitarbeiter

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

Ermittler

  • Studienstuhl: Paal Oian, Professor MD, University Hospital of North Norway

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2015

Primärer Abschluss (Tatsächlich)

1. Januar 2018

Studienabschluss (Tatsächlich)

1. Januar 2018

Studienanmeldedaten

Zuerst eingereicht

2. Februar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Februar 2015

Zuerst gepostet (Schätzen)

5. Februar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Mai 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Mai 2018

Zuletzt verifiziert

1. Mai 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2014/1398 (REK)

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