Intralesional Versus Perilesional 5% Dextrose Injection in Partial Rotator Cuff Tears
Comparison of Clinical and Ultrasonographic Outcomes of Intralesional and Perilesional 5% Dextrose Injection in Patients With Partial Rotator Cuff Tears: A Prospective Randomized Double-Blind Controlled Trial
調査の概要
状態
詳細な説明
Rotator cuff tears are one of the leading causes of shoulder pain and functional limitation. Partial rotator cuff tears may become chronic and may not respond adequately to conventional conservative treatments such as activity modification, physical therapy, and nonsteroidal anti-inflammatory drugs.
Dextrose injection is a regenerative injection therapy that aims to stimulate tissue healing responses in chronic musculoskeletal disorders. It is thought to promote fibroblast activation, collagen synthesis, and proliferative healing processes in degenerative tendon, ligament, and enthesis lesions. Ultrasound guidance allows accurate and safe delivery of the injectate to the target tissue and enables objective follow-up of tendon morphology during the treatment process.
This study will include adult patients with partial rotator cuff tears diagnosed by clinical examination and imaging. Participants will be randomized into two groups using a computer-based random number system. The researcher performing the randomization will know the treatment allocation, while the participants and the physician assessing the clinical outcomes will be blinded to treatment groups.
Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. The intralesional group will additionally receive intralesional 5% dextrose injection, and the perilesional group will additionally receive perilesional 5% dextrose injection. Injections will be applied using the peppering technique, with 0.1-0.2 cc administered to each point. A total of three treatment sessions will be performed at 21-day intervals.
Clinical outcomes will include shoulder pain assessed by the Numeric Rating Scale, shoulder pain and disability assessed by the Shoulder Pain and Disability Index, and health-related quality of life assessed by the Short Form-12 Health Survey. Ultrasonographic outcomes will include supraspinatus tendon thickness and partial defect size. Clinical evaluations will be performed at baseline, 9 weeks, and 12 weeks after treatment. Ultrasonographic evaluations will be performed at baseline and 12 weeks.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Esra Ülgen Kıratlıoğlu, MD
- 電話番号：+905079614194
- メール：esraulgen@gmail.com
研究場所
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-
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Ankara、トルコ（Türkiye）
- 募集
- Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
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コンタクト：
- Esra Ülgen Kıratlıoğlu
- 電話番号：+905079614194
- メール：esraulgen@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Diagnosis of partial rotator cuff tear by a specialist physician after appropriate clinical examination and imaging evaluation
- Shoulder pain and functional limitation lasting for at least 3 months
- Clinically confirmed shoulder impingement findings, defined as at least one positive test among Neer, Hawkins-Kennedy, or painful arc tests
- Age between 18 and 75 years
- Ability to comply with the study procedures and attend follow-up visits regularly
- Willingness to participate in the study and provide written informed consent
Exclusion Criteria:
- Advanced cognitive impairment or dementia preventing reliable completion of questionnaires
- Refusal to participate in the study or inability to provide informed consent
- Full-thickness rotator cuff tear
- Major tendon pathology other than the supraspinatus tendon, such as full-thickness subscapularis tear or biceps tendon rupture
- Advanced acromioclavicular joint osteoarthritis, marked impingement, or marked adhesive capsulitis
- Advanced glenohumeral joint arthritis
- Active infection, cellulitis, or dermatologic lesion at the injection site
- Bleeding diathesis or anticoagulant use
- Known allergy or intolerance to dextrose injection
- Intra-articular shoulder injection, including steroid, platelet-rich plasma, or prolotherapy, within the last 3 months
- Previous shoulder surgery
- Uncontrolled diabetes mellitus, defined as HbA1c >8.5%, or severe endocrine or metabolic disorder
- Immunosuppression or active infection
- Rheumatologic shoulder involvement
- Neurological disease affecting shoulder movements
- Pregnancy
- Active malignancy
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 |
|---|---|
|
実験的：Intralesional 5% Dextrose Injection
Participants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis.
In addition, intralesional 5% dextrose injection will be applied to the partial rotator cuff tear using the peppering technique.
Injections will be performed in three treatment sessions at 21-day intervals.
All participants will receive a home-based exercise program after completion of the injection treatments.
|
Ultrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally into the partial tear lesion using the peppering technique.
A volume of 0.1-0.2
cc will be administered to each point.
The treatment will consist of three sessions performed at 21-day intervals.
|
|
アクティブコンパレータ：Perilesional 5% Dextrose Injection
Participants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis.
In addition, perilesional 5% dextrose injection will be applied around the partial rotator cuff tear using the peppering technique.
Injections will be performed in three treatment sessions at 21-day intervals.
All participants will receive a home-based exercise program after completion of the injection treatments.
|
Ultrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally around the partial tear lesion using the peppering technique.
A volume of 0.1-0.2
cc will be administered to each point.
The treatment will consist of three sessions performed at 21-day intervals.
|
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 |
|---|---|---|
|
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
時間枠：Baseline, 9 weeks, and 12 weeks after treatment
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Shoulder pain intensity will be assessed using the Numeric Rating Scale.
Night pain, worst daytime shoulder pain, and average shoulder pain will be evaluated on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate greater pain intensity.
|
Baseline, 9 weeks, and 12 weeks after treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
時間枠：Baseline, 9 weeks, and 12 weeks after treatment
|
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index.
The scale consists of 13 items in two domains: pain and disability.
Each item is scored from 0 to 10, and the total score is converted to a 0-100 scale.
Higher scores indicate greater pain and functional impairment.
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Baseline, 9 weeks, and 12 weeks after treatment
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Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey
時間枠：Baseline, 9 weeks, and 12 weeks after treatment
|
Health-related quality of life will be assessed using the Short Form-12 Health Survey.
The questionnaire includes 12 items and provides physical component summary and mental component summary scores.
Higher scores indicate better health-related quality of life.
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Baseline, 9 weeks, and 12 weeks after treatment
|
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Change in Supraspinatus Tendon Thickness Assessed by Ultrasonography
時間枠：Baseline and 12 weeks after treatment
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Supraspinatus tendon thickness will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
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Baseline and 12 weeks after treatment
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Change in Partial Rotator Cuff Defect Size Assessed by Ultrasonography
時間枠：Baseline and 12 weeks after treatment
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Partial rotator cuff defect size will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
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Baseline and 12 weeks after treatment
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協力者と研究者
捜査官
- 主任研究者：ESRA Ülgen Kıratlıoğlu、Ankara City Hospital Bilkent
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
キーワード
その他の研究ID番号
- E2-26-14590
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