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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Troms
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Tromso、Troms、ノルウェー、9038
- University Hospital of North Norway
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in pelvic pain
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in subjective health complaints
時間枠：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,
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
協力者
捜査官
- スタディチェア：Paal Oian, Professor MD、University Hospital of North Norway
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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