Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care
Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care: a Randomized Controlled Trial
調査の概要
状態
詳細な説明
The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.
Patients seeking care due to disabling back, neck or shoulder pain at seven primary health care units in the County of Dalarna, Sweden, was randomly allocated to ALAR or usual multimodal rehabilitation. Between and within-group differences on return-to-work, sickness absence and disability will be evaluated at 10 weeks, six months, one and two years post-treatment.
The enrollment of patients was ended on preterm in june 2013. Due to changes in the organization in primary health care it was no longer possible to ensure that treatment arms could be delivered as intended. Data collection up to 1-year follow-up is completed. Data from longterm follow-up at 2 years will be completed in june 2015. Data analyses and reporting of results is presently undertaken. The number of enrolled participants is not enough to reach statistical power. Thus, results will need to be interpreted with caution.
Still the results of this pragmatic study will be of importance for the planning of a full scale study to accurately evaluate the effects of ALAR, to be conducted in primary care.
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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Falun、スウェーデン、79182
- The County Council of Dalarna; Primary Health Care units
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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:
- Persons seeking primary health care due to back, neck or shoulder pain
- Aged 18 to 60 years
- Being on sick leave or disability compensation
- Able to understand, read and write Swedish
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：Activity targeted pain rehabilitation
A new activity and life-role targeting pain rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work.
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An activity and life-role targeting rehabilitation programme (ALAR) provided by one of the care givers in the multi-professional rehabilitation teams at each of the eight participating primary health care centres, by ten weekly 1-hour treatment sessions.
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アクティブコンパレータ：Treatment as usual
Usual treatment consisting of multimodal rehabilitation provided by multi-professional teams in primary health care in the County of Dalarna, Sweden.
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Usual treatment with type of treatment modalities, number, frequency and duration of visits according to the judgement of the muli-professional teams at each primary health care centre.
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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 |
|---|---|---|
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Number of days of sickness absence from work
時間枠：6 months
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Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
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6 months
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Number of days of sickness absence from work
時間枠：1 year
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Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
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1 year
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Number of days of sickness absence from work
時間枠：2 years
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Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.
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2 years
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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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Return-to-work after sickness absence
時間枠：Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
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Number of participants that return to work after sickness absence, i.e. that were on sick leave before the study and that has returned to work after the study.
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Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
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Disability
時間枠：Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
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Pain-related disability according to Pain Disability Index (PDI).
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Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)
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協力者と研究者
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 (見積もり)
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。
筋骨格系の首の痛みの臨床試験
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Dexa Medica Group完了
Activity targeted pain rehabilitationの臨床試験
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Bahçeşehir UniversityNevsehir Haci Bektas Veli Universityまだ募集していません