Motor Control Training in Individuals With Subacromial Pain Syndrome
Motor Control Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial
調査の概要
詳細な説明
Methods: This is a randomized controlled trial which will be composed of volunteers of both genders, aged between 35 and 60 years. All volunteers will undergo pre-assessment (Av1): pain sensation, pain and function, shoulder range of motion, muscle strength, electromyographic activity and kinematics of the shoulder complex. After the initial evaluation, the volunteers will be randomly divided into two groups to carry out the intervention: exercises (GE - conventional exercises with elastic band) and motor control (GCM - motor control training). The intervention protocol will last eight weeks. After four weeks, the second assessment (AV2), similar to AV1, will be performed and the global change perception questionnaire will be added. At the end of the intervention protocol, the third evaluation (AV3), similar to AV2, will be performed. A follow-up will be performed after 4 weeks of the end of the intervention protocol, with the assessment being equal to AV3.
The project will be submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also be registered on the international clinical trial platform, ClinicalTrials.gov. The study will only begin after approval of the ethics and research committee. All volunteers should read and sign the terms of free and informed consent.
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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RN
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Natal、RN、ブラジル、59140-840
- Jamilson S Brasileiro
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Parnamirim、RN、ブラジル、59152820
- Karinna Sonálya Aires da Costa
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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:
- Present subacromial pain with a score greater than or equal to 2 (Visual Analog Scale) for more than 2 months;
- Positive Neer test;
- Positive Hawkins test;
- Positive Jobe test (pain);
- Positive Patte test (pain);
- Involvement of the supraspinatus and / or infraspinatus tendon (without degenerative characteristics) confirmed by Magnetic Nuclear Resonance (MRI) examination.
Exclusion Criteria:
- Intense pain during the evaluations;
- Fail to properly perform the evaluation procedures;
- Two consecutive or five alternating absences during the training protocol.
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：motor control training
8-week exercise program, twice a week, with motor control training
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The volunteers of the motor control group will initiate the exercises on a stable and rigid basis.
These will be progressed with adding an unstable base as the volunteer gains motor learning (between the fourth and fifth week of the protocol).
For the motor control group, two sets of 10 repetitions will be performed keeping in isometry for ten seconds each repetition.
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アクティブコンパレータ：exercises
8-week exercise program, twice a week.
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the protocol of strengthening and will have five elastic bands with different resistances available (extra-light, light, moderate, strong and extra-strong) for elbow flexion exercises progression, medial rotation and lateral rotation of the shoulder and scapular retraction.
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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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Shoulder pain
時間枠：Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Evaluation of pain level in the shoulder using the Numerical Pain Scale, graded from 0 to 10, where 0 indicates absence of pain and 10 indicates the worst pain imaginable.
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Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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肩の機能
時間枠：4週間、8週間での肩機能のベースラインからの変化、および介入プロトコル後の4週間のフォローアップ
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Disabilities of the Arm, Shoulder and Hand (DASH) を使用した肩の痛みと機能の評価。
質問票は、自己評価の上肢障害および症状の尺度として開発された自己管理型の地域固有の結果測定器です。
DASH は、主に 30 項目の障害/症状スケールで構成され、0 (障害なし) から 100 までのスコアが付けられます。
スコアが高いほど、機能障害が大きくなります。
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4週間、8週間での肩機能のベースラインからの変化、および介入プロトコル後の4週間のフォローアップ
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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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Root Mean Square (RMS)
時間枠：Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Analyze of the electromyographic activity of the muscles shoulder complex, after 4 and 8 weeks of the protocol and a follow up of 4 weeks after the intervention protocol, by Root Mean Square (RMS)
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Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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The kinematics of the scapula
時間枠：Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Analyze the kinematics of the scapula and glenohumeral in the slow and habitual movements after 8 weeks of the protocol and a follow up of 4 weeks.
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Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Peak of muscular torque
時間枠：Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Evaluate the peak of muscular torque, by means of the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
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Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Peak torque time
時間枠：Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Evaluate the peak torque time, using the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
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Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Range of motion
時間枠：Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Measure the range of motion for flexion, hyperextension, internal and external shoulder rotation 8 weeks of protocol and a follow up of 4 weeks, through the inclinometer.
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Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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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 (実際)
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 (実際)
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。