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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Esra Ülgen Kıratlıoğlu, MD
- Telefonszám: +905079614194
- E-mail: esraulgen@gmail.com
Tanulmányi helyek
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-
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Ankara, Törökország (Türkiye)
- Toborzás
- Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
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Kapcsolatba lépni:
- Esra Ülgen Kıratlıoğlu
- Telefonszám: +905079614194
- E-mail: esraulgen@gmail.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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.
|
|
Aktív összehasonlító: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
Időkeret: Baseline, 9 weeks, and 12 weeks after treatment
|
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.
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Baseline, 9 weeks, and 12 weeks after treatment
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
Időkeret: Baseline, 9 weeks, and 12 weeks after treatment
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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
Időkeret: Baseline, 9 weeks, and 12 weeks after treatment
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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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: ESRA Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- E2-26-14590
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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