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L'essai clinique NCT06725823 pour Épaule gelée est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Therapeutic Effect of Shoulder Anterior Capsular Block Versus Suprascapular Nerve Block in Patients With Frozen Shoulder 50 Randomisé
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L'essai clinique NCT06725823 est une étude interventionnel pour Épaule gelée. Son statut actuel est : en recrutement. L'étude a débuté le 10 janvier 2025 et vise à recruter 50 participants. Dirigée par l'Université de Sohag, l'étude devrait être terminée d'ici le 1 juillet 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 15 mai 2025.
Résumé succinct
he study will include 50 patients with frozen shoulder with no healthy volunteer , Patients in this study will be randomized into two groups suprascapular nerve block and Shoulder anterior capsular block
Description détaillée
The study will include 50 patients with frozen shoulder with no healthy volunteer , Patients in this study will be randomized into two groups according to the treatment performed .
Shoulder anterior capsular block group
Description:
Ultrasound guided injection For the SHAC block, with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes ...
Afficher plusTitre officiel
Therapeutic Effect of Shoulder Anterior Capsular Block (SHAC) Versus Suprascapular Nerve Block in Patients With Frozen Shoulder
Pathologies
Épaule geléePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- Soh-Med-24-11__2MD
Numéro NCT
Date de début (réel)
2025-01-10
Dernière mise à jour publiée
2025-05-15
Date de fin (estimée)
2026-07-01
Inscription (estimée)
50
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Groupe unique
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifsuprascapular nerve block group Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine the needle will be inserted .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed | suprascapular nerve block group A volume of (10 ml) of 2% lidocaine (7ml), 3% Mepivacaine (2ml), 1 ml methyl-prednisolone acetate (40 mg) will be injected to both groups. |
Comparateur actifshoulder anterior capsular block group Ultrasound guided injection For the SHAC block, with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible. With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the s...Afficher plus | shoulder anterior capsular block group A volume of (10ml) of 2% lidocaine (7ml), 3% Mepivacaine (2ml), 1 ml methyl-prednisolone acetate (40mg) will be injected to both groups. |
Critère principal d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Pain (Visual analogue scale) | s a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. | at baseline and post-procedure at 1, 3 and 6 months. |
total pain scores | is a combination of simple pain score, radiation, and sleep disturbance score | at baseline and post-procedure at 1, 3 and 6 months. |
shoulder pain disability index | The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder. | at baseline and post-procedure at 1, 3 and 6 months. |
active range of movement of the shoulder joint | The active and passive range of abduction, adduction, flexion , extension , internal rotation and external rotation will be measured using goniometry | at baseline and post-procedure at 1, 3 and 6 months. |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
19 Years
Sexes éligibles
Tous
Age above 18 years.
- Both sexes, males and females.
- History of complaint >6 weeks
- Restricted shoulder movement unilaterally in at least 2 planes including abduction, external rotation, and internal rotation and restricted passive movement.
Patient refusal.
- -Allergy to local anaesthetics.
- -Infection at the site of injection .
- -Coagulopathy
- -Prolonged opioid medication
- -Pregnancy
- -Acute trauma, fracture of the shoulder
- People who had received an intra-articular shoulder injection within the last 6 months.
- Patients with tendon tear
Partie responsable de l'étude
Ayat Abdulwahab Othman, Investigateur principal, Assistant lecturer of Physical Medicine, Rheumatology &Rehabilitation, Sohag University
Contact central de l'étude
Contact: Hanan Sayed Mohamed AboZaid, Professor, 01017049050, [email protected]
1 Centres de l'étude dans 1 pays
Sohag university, Sohag, Egypt
Hanan S Mohamed AboZaid, professor, Contact, 01017049050, [email protected]
Ayat Abdulwahab Othman Mahmoud, MSc, Investigateur principal
En recrutement