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

2 maggio 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

62

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Comparatore attivo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in pelvic pain
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in subjective health complaints
Lasso di tempo: 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,
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital of North Norway

Collaboratori

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

Investigatori

  • Cattedra di studio: Paal Oian, Professor MD, University Hospital of North Norway

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2015

Completamento primario (Effettivo)

1 gennaio 2018

Completamento dello studio (Effettivo)

1 gennaio 2018

Date di iscrizione allo studio

Primo inviato

2 febbraio 2015

Primo inviato che soddisfa i criteri di controllo qualità

2 febbraio 2015

Primo Inserito (Stima)

5 febbraio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 maggio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2014/1398 (REK)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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