Physical Therapy After Reverse Total Shoulder Arthroplasty
Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial
調査の概要
詳細な説明
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.
There is very limited orthopaedic literature focusing on the postoperative rehabilitation after reverse TSA. The majority of research is in the physical therapy literature focusing on the actual rehabilitation protocol. However, there has never been a large, randomized clinical trial that asks the question of whether or not physical therapy after reverse TSA is even necessary, or if patients will have comparable outcomes if they perform their own at home rehabilitation. There are surgeons nationwide that are on either end of the spectrum. Some encourage patients to see a therapist for a prolonged period of time with a set regimen of exercises, while others do not encourage any formal physical therapy and instead give patients a list of movements not to perform and allow them to recover at their own pace. We hypothesize that there will be comparable clinical outcomes between patients randomized to receive physical therapy versus an at home, self-led rehabilitation protocol. There are no deleterious effects of either treatment wing.
Patients who agree to undergo reverse TSA after a preoperative appointment with their attending surgeon will be invited to participate in the study. They will complete the below mentioned survey instruments. They will receive their procedure and appropriate postoperative treatment. Patients will then be randomized to either the physical therapy or self-rehab group. Both groups will receive the standard postoperative physical therapy protocol. The only difference between the groups will be if a physical therapist sees the patients in their clinic, or if the patients self-rehabilitate with a list of limitations throughout their recovery course. The physical therapy protocol provided to the physical therapists and patients is attached.
Clinical outcomes will be measured using the attached survey instruments: Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons Shoulder Score (ASES-SS), and the Single Assessment Numeric Evaluation score (SANE). These are commonly used, validated survey instruments in the setting of orthopaedic shoulder research.
The physical exam component of the study will include range of motion testing (measuring the degrees of movement using a goniometer) and strength testing (measured using the dynamometer) in both shoulders.
These survey instruments and measurements will be performed at 3, 6, and 12 month postoperative follow up.
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
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35205
- UAB Hospital Highlands
-
-
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:
- • Patients who agree to receive a reverse total shoulder arthroplasty by one of our participating surgeons
Exclusion Criteria:
• Revision shoulder replacement surgery
- Mentally incompetent to provide informed consent
- Non-english speaking
- Minors (<18)
- Pregnant women
- Prison population
- Acute Shoulder Fractures
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Physical Therapy
This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.
|
These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
|
実験的:Self-Rehab
This group of patients will be provided with a list of actions not to perform during the stages of their rehab (to avoid injury), and allowed to rehab their shoulder at their own pace.
|
These patients will be provided with a list of actions NOT to perform and allowed to self rehabilitate.
They will not see a physical therapist.
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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 |
---|---|---|
Forward Flexion Range of Motion 1
時間枠:3 months followup
|
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
|
3 months followup
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Strength 1
時間枠:3 months followup
|
Strength measured using a dynamometer
|
3 months followup
|
Simple Shoulder Test Patient Reported Outcome 1
時間枠:3 months followup
|
12 question questionnaire, scores are 0-12, 12 is best score (normal)
|
3 months followup
|
Strength 2
時間枠:6 month followup
|
Strength measured using a dynamometer
|
6 month followup
|
Strength 3
時間枠:12 months followup
|
Strength measured using a dynamometer
|
12 months followup
|
Internal Rotation Range of Motion 1
時間枠:3 months followup
|
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
|
3 months followup
|
External Rotation Range of Motion 1
時間枠:3 months followup
|
Active range of motion in the shoulder joint in external rotation (measured in degrees)
|
3 months followup
|
Internal Rotation Range of Motion 2
時間枠:6 month followup
|
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
|
6 month followup
|
External Rotation Range of Motion 2
時間枠:6 month followup
|
Active range of motion in the shoulder joint in external rotation (measured in degrees)
|
6 month followup
|
Forward Flexion Range of Motion 2
時間枠:6 months followup
|
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
|
6 months followup
|
Forward Flexion Range of Motion 3
時間枠:12 months followup
|
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
|
12 months followup
|
Internal Rotation Range of Motion 2
時間枠:12 months followup
|
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
|
12 months followup
|
External Rotation Range of Motion 2
時間枠:12 months followup
|
Active range of motion in the shoulder joint in external rotation (measured in degrees)
|
12 months followup
|
American Shoulder and Elbow Surgeons Shoulder Score 1
時間枠:3 month followup
|
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
|
3 month followup
|
Simple Shoulder Test Patient Reported Outcome 2
時間枠:6 month followup
|
12 question questionnaire, scores are 0-12, 12 is best score (normal)
|
6 month followup
|
Simple Shoulder Test Patient Reported Outcome 3
時間枠:12 month followup
|
12 question questionnaire, scores are 0-12, 12 is best score (normal)
|
12 month followup
|
Single Assessment Numeric Evaluation (SANE) Score 1
時間枠:3 month followup
|
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
|
3 month followup
|
American Shoulder and Elbow Surgeons Shoulder Score 2
時間枠:6 month followup
|
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
|
6 month followup
|
American Shoulder and Elbow Surgeons Shoulder Score 3
時間枠:12 month followup
|
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
|
12 month followup
|
Single Assessment Numeric Evaluation (SANE) Score 2
時間枠:6 month followup
|
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
|
6 month followup
|
Single Assessment Numeric Evaluation (SANE) Score 3
時間枠:12 month followup
|
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
|
12 month followup
|
協力者と研究者
捜査官
- 主任研究者:Amit M Momaya, MD、University of Alabama at Birmingham
研究記録日
主要日程の研究
研究開始 (実際)
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研究の完了 (実際)
試験登録日
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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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- F11223344
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