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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Troms
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Tromso, Troms, Норвегия, 9038
- University Hospital of North Norway
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Активный компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Changes in pelvic pain
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Changes in subjective health complaints
Временное ограничение: 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,
Временное ограничение: From baseline to 12 months after start of intervention
|
Measured with Tampa Scale of Kinesiophobia, a self-completed questionnaire.
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From baseline to 12 months after start of intervention
|
|
Changes in sexual function concerning pain during intercourse
Временное ограничение: 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".
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From baseline to 12 months after start of intervention
|
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Changes in general health condition
Временное ограничение: 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.
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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
Временное ограничение: From baseline to 12 months
|
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
Временное ограничение: 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.
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From baseline to 12 months after start of intervention
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Соавторы и исследователи
Соавторы
Следователи
- Учебный стул: Paal Oian, Professor MD, University Hospital of North Norway
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2014/1398 (REK)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .