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

2 mai 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

62

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Comparateur actif: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in pelvic pain
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in subjective health complaints
Délai: 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,
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital of North Norway

Collaborateurs

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

Les enquêteurs

  • Chaise d'étude: Paal Oian, Professor MD, University Hospital of North Norway

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2015

Achèvement primaire (Réel)

1 janvier 2018

Achèvement de l'étude (Réel)

1 janvier 2018

Dates d'inscription aux études

Première soumission

2 février 2015

Première soumission répondant aux critères de contrôle qualité

2 février 2015

Première publication (Estimation)

5 février 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 mai 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 mai 2018

Dernière vérification

1 mai 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2014/1398 (REK)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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