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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Esra Ülgen Kıratlıoğlu, MD
- Numéro de téléphone: +905079614194
- E-mail: esraulgen@gmail.com
Lieux d'étude
-
-
-
Ankara, Turquie (Türkiye)
- Recrutement
- Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
-
Contact:
- Esra Ülgen Kıratlıoğlu
- Numéro de téléphone: +905079614194
- E-mail: esraulgen@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
Délai: 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.
|
Baseline, 9 weeks, and 12 weeks after treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
Délai: 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.
|
Baseline, 9 weeks, and 12 weeks after treatment
|
|
Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey
Délai: 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.
|
Baseline, 9 weeks, and 12 weeks after treatment
|
|
Change in Supraspinatus Tendon Thickness Assessed by Ultrasonography
Délai: Baseline and 12 weeks after treatment
|
Supraspinatus tendon thickness will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
|
Baseline and 12 weeks after treatment
|
|
Change in Partial Rotator Cuff Defect Size Assessed by Ultrasonography
Délai: Baseline and 12 weeks after treatment
|
Partial rotator cuff defect size will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
|
Baseline and 12 weeks after treatment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: ESRA Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E2-26-14590
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .