Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
調査の概要
状態
条件
詳細な説明
Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living.
Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT).
The study is designed as a randomised, single blind clinical controlled study.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Oslo、ノルウェー、0407
- Department for physical medicine and rehabilitation, Ullevaal University Hospital
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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:
- Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
- Dysfunction or pain on abduction
- Had a normal passive glenohumeral range of movement
- Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
- Positive Hawkins-Kennedys test.
Exclusion Criteria:
- Shoulder pain bilateral (both shoulders required treatment)
- Earlier operated in affected shoulder
- Had multidirectional instability
- Had the cervical syndrome
- Rheumatoid arthritis
- Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology
- Not able to understand spoken or written Norwegian
- Considerable emotional distress
- Needed anticoagulant medicine
- Being pregnant
- Had had Shock Wave Therapy or Supervised Exercises before.
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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アクティブコンパレータ：A
Supervised Exercises performed at ulleval Hospital for patients with shoulder pain.
Dosage: 45 minutes each time, max 2-3 times a week in max 12 weeks
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Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
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アクティブコンパレータ：B
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
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Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
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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 |
時間枠 |
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Shoulder Pain and Disability Index (SPADI)
時間枠：Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
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Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week.
時間枠：Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
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Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
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協力者と研究者
捜査官
- 主任研究者：Kaia Engebretsen, PhD、Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
出版物と役立つリンク
一般刊行物
- Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Juel NG, Brox JI. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther. 2011 Jan;91(1):37-47. doi: 10.2522/ptj.20090338. Epub 2010 Nov 18.
- Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Brox JI. Predictors of shoulder pain and disability index (SPADI) and work status after 1 year in patients with subacromial shoulder pain. BMC Musculoskelet Disord. 2010 Sep 23;11:218. doi: 10.1186/1471-2474-11-218.
- Engebretsen K, Grotle M, Bautz-Holter E, Sandvik L, Juel NG, Ekeberg OM, Brox JI. Radial extracorporeal shockwave treatment compared with supervised exercises in patients with subacromial pain syndrome: single blind randomised study. BMJ. 2009 Sep 15;339:b3360. doi: 10.1136/bmj.b3360.
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 (予想される)
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。
肩凝りの臨床試験
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