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L'essai clinique NCT06916650 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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Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder 180 Exercice
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L'essai clinique NCT06916650 est une étude interventionnel pour Épaule gelée. Son statut actuel est : en recrutement. L'étude a débuté le 25 avril 2025 et vise à recruter 180 participants. Dirigée par Al Hayah University In Cairo, l'étude devrait être terminée d'ici le 1 août 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 8 avril 2025.
Résumé succinct
This study compares three common treatments for frozen shoulder when added to a standard exercise program: High-Intensity Laser Therapy (HILT), a corticosteroid (steroid) injection into the shoulder joint, and hands-on manual therapy by a physical therapist. A fourth group will receive only the standard exercise program. The goal is to see which combination works best to reduce shoulder pain and improve shoulder func...Afficher plus
Titre officiel
Comparative Effectiveness of High-Intensity Laser Therapy Versus Corticosteroid Injection Versus Manual Therapy, Each Combined With Standard Exercise, for Frozen Shoulder (Adhesive Capsulitis): A Randomized Controlled Trial
Pathologies
Épaule geléeAutres identifiants de l'étude
- COMPARE-FS
Numéro NCT
Date de début (réel)
2025-04-25
Dernière mise à jour publiée
2025-04-08
Date de fin (estimée)
2027-08-01
Inscription (estimée)
180
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalHILT + Standard Exercise Participants receive High-Intensity Laser Therapy (HILT) 2 times/week for 6 weeks, plus the Standard Exercise Program. | High-Intensity Laser Therapy (HILT) Nd:YAG laser (1064 nm) applied to anterior, lateral, posterior glenohumeral joint aspects. Three-phase protocol per session: (1) 10 J/cm² @ 10 Hz; (2) 12 J/cm² @ 2000 Hz; (3) 10 J/cm² @ 15 Hz. Total energy \~1200 J/session. Frequency: 2 sessions/week for 6 weeks (12 sessions total). Delivered by trained PTs. Standard Exercise Program Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 wee...Afficher plus |
Comparateur actifCorticosteroid Injection + Standard Exercise Participants receive a single ultrasound-guided intra-articular corticosteroid injection at baseline, plus the Standard Exercise Program. | Ultrasound-Guided Intra-articular Corticosteroid Injection Single injection into the glenohumeral joint under ultrasound guidance. Consists of 40 mg methylprednisolone acetate combined with 4 ml of 1% lidocaine hydrochloride. Delivered at baseline by an experienced orthopedic physician. Standard Exercise Program Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 wee...Afficher plus |
Comparateur actifManual Therapy + Standard Exercise Participants receive manual therapy 2 times/week for 6 weeks, plus the Standard Exercise Program. | Thérapie manuelle Skilled hands-on techniques including glenohumeral joint mobilizations (Maitland grades III-IV), posterior capsule stretching, scapular mobilization, and soft tissue techniques targeting restricted tissues. Session duration: \~30 minutes. Frequency: 2 sessions/week for 6 weeks (12 sessions total). Delivered by PTs specialized in manual therapy. Standard Exercise Program Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 wee...Afficher plus |
Comparateur actifStandard Exercise Alone Participants receive the Standard Exercise Program only. | Standard Exercise Program Standardized program including pendulum exercises, active-assisted range of motion exercises (e.g., wand, wall climbs), stretching (e.g., cross-body, sleeper stretch), and progressive resistive exercises using resistance bands. Includes supervised instruction/progression and a daily home exercise program component. Supervised instruction frequency: 2 sessions/week for first 6 weeks, then 1 session/week for next 6 wee...Afficher plus |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in Shoulder Pain Intensity | Visual Analogue Scale (VAS) for Pain. Change from baseline in average shoulder pain over the past week, measured on a 10 cm horizontal VAS, where 0 cm = no pain and 10 cm = worst imaginable pain. Lower scores indicate less pain. MCID estimated at 1.4 cm. | Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3) |
Change in Shoulder Pain and Disability | Shoulder Pain and Disability Index (SPADI). Change from baseline in the total SPADI score. SPADI consists of 13 items assessing pain (5 items) and disability (8 items). Total score ranges from 0-100, with lower scores indicating less pain and disability. | Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3) |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in Passive Shoulder Range of Motion (ROM) | Change from baseline in passive shoulder ROM measured in degrees for: External Rotation (at side), Abduction (in scapular plane), Flexion, and Internal Rotation (vertebral level reached). Measured using a standard goniometer. | Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3) |
Patient Global Rating of Change | Global Rating of Change (GRC) Scale. Patient's self-rated overall change in their shoulder condition since starting the study, measured on a Likert scale (e.g., 7-point scale from "very much worse" to "very much improved"). Assessed relative to baseline. | 6 weeks (T1), 12 weeks (T2), 6 months (T3) |
Incidence of Adverse Events | Number, type, and severity of any adverse events (AEs) reported by participants or observed by study staff throughout the study duration, categorized by potential relationship to the assigned intervention (e.g., post-injection flare, skin reaction to HILT, increased pain after manual therapy/exercise). | Throughout study participation (up to 6 months) |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
40 Years
Sexes éligibles
Tous
Age between 40 and 70 years, inclusive. Clinical diagnosis of primary (idiopathic) frozen shoulder, defined by shoulder pain and ≥50% restriction in passive external rotation compared to the contralateral (unaffected) shoulder.
Symptom duration between 3 and 9 months. Average shoulder pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) over the past week.
Normal or age-appropriate radiographic findings of the glenohumeral joint (ruling out significant arthritis, fractures, calcific tendinitis).
Willingness and ability to attend scheduled treatment/assessment sessions. Ability to understand study procedures and provide written informed consent.
Secondary frozen shoulder (e.g., post-traumatic, post-surgical, related to systemic disease like diabetes - clarify if diabetes is excluded or just secondary FS from diabetes).
Clinical or imaging evidence of significant rotator cuff tear requiring specific management.
Radiographic evidence of moderate to severe glenohumeral osteoarthritis (e.g., Kellgren-Lawrence grade ≥ 3).
Previous surgery on the index shoulder. Significant neurological disorders affecting shoulder or upper extremity function (e.g., cervical radiculopathy, stroke).
Received a corticosteroid injection in the index shoulder within the past 3 months.
Known contraindications to corticosteroid injections (e.g., uncontrolled diabetes, allergy, local infection).
Known contraindications to High-Intensity Laser Therapy (e.g., active malignancy in the treatment area, photosensitivity, pacemaker over treatment area).
Current participation in another interventional clinical trial for shoulder pain.
Al Hayah University In CairoContact central de l'étude
Contact: Ibrahim Zoheiry, Ph.D, 01277774949, [email protected]
Contact: Mohamed ElMeligie, Ph.D, [email protected]
1 Centres de l'étude dans 1 pays
Faculty of Physical Therapy, Al Hayah University, Cairo, 12311, Egypt
Mohamed ElMeligie, Ph.D, Contact, 01159880001, [email protected]
En recrutement