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L'essai clinique NCT07416916 (CUSIS-FS) 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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Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder (CUSIS-FS) Phase IV 528 Exercice
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07416916 (CUSIS-FS) est conçu pour étudier le traitement de Épaule gelée. Il s'agit d'une étude interventionnel en Phase IV. Son statut actuel est : en recrutement. L'étude a débuté le 23 février 2026 et vise à recruter 528 participants. Dirigée par Second Affiliated Hospital, School of Medicine, Zhejiang University, l'étude devrait être terminée d'ici le 1 janvier 2031. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 25 février 2026.
Résumé succinct
The goal of this clinical trial is to determine if a gluteal muscle injection of compound betamethasone is as effective as an ultrasound-guided intra-articular injection in treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 65. The main questions it aims to answer are:
- Is gluteal injection as effective as ultrasound-guided intra-articular injection for improving shoulder function and reducing pain...
Titre officiel
Ultrasound-Guided Intra-Articular Versus Systemic Corticosteroid Injection for Frozen Shoulder: A Multicenter, Blinded, Randomized Controlled Trial
Pathologies
Épaule geléeAutres identifiants de l'étude
- CUSIS-FS
- 2024-0434
Numéro NCT
Date de début (réel)
2026-02-23
Dernière mise à jour publiée
2026-02-25
Date de fin (estimée)
2031-01
Inscription (estimée)
528
Type d'étude
Interventionnel
PHASE
Phase IV
Statut
En recrutement
Mots clés
frozen shoulder
intramuscular injection
compound betamethasone
ultrasound guidance
intra-articular injection
intramuscular injection
compound betamethasone
ultrasound guidance
intra-articular injection
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalSystemic steroid / Gluteal injection At Week 0 (baseline), participants receive a single dorsogluteal intramuscular injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single ultrasound-guided intra-articular glenohumeral injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for ...Afficher plus | Compound betamethasone injection (dorsogluteal intramuscular) A single dorsogluteal intramuscular injection at Week 0 (baseline): compound betamethasone 1 mL mixed with 0.9% sodium chloride 4 mL (total volume 5 mL), as part of a double-dummy design. 0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo) A single ultrasound-guided intra-articular glenohumeral placebo injection at Week 0 (baseline): 0.9% sodium chloride 5 mL, to mimic the local (intra-articular) injection in the double-dummy design. Standardized home-based shoulder rehabilitation exercise program All participants perform a standardized home-based rehabilitation exercise program for 12 weeks after outpatient instruction, approximately 40 minutes per day (twice daily, 20 minutes per session), following the study-provided instructional video. |
Comparateur actifLocal steroid / Intra-articular injection At Week 0 (baseline), participants receive a single ultrasound-guided intra-articular glenohumeral injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single dorsogluteal intramuscular injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for ...Afficher plus | Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral) A single ultrasound-guided intra-articular glenohumeral injection at Week 0 (baseline): compound betamethasone 1 mL mixed with 0.9% sodium chloride 4 mL (total volume 5 mL), as part of a double-dummy design. 0.9% sodium chloride injection (dorsogluteal intramuscular placebo) A single dorsogluteal intramuscular placebo injection at Week 0 (baseline): 0.9% sodium chloride 5 mL, to mimic the systemic (intramuscular) injection in the double-dummy design. Standardized home-based shoulder rehabilitation exercise program All participants perform a standardized home-based rehabilitation exercise program for 12 weeks after outpatient instruction, approximately 40 minutes per day (twice daily, 20 minutes per session), following the study-provided instructional video. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8 | Shoulder Pain and Disability Index (SPADI) total score (validated Simplified Chinese version; range 0-100, where 0 = no pain/disability and 100 = worst pain/disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Primary endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 8 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Change in QuickDASH Score from Baseline to Week 8 | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (official Simplified Chinese version; range 0-100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 8 |
Change in EQ-5D-5L Index Score from Baseline to Week 8 | EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (Simplified Chinese version; index derived using the Chinese value set; range -0.391 to 1.000, where 1.000 = full health and higher scores indicate better health-related quality of life). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); positive change indicates improvement. | Baseline (Week 0) to Week 8 |
Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 8 | Worst shoulder pain in the past 24 hours measured by a Numeric Rating Scale (NRS) item from the Brief Pain Inventory-Chinese version (BPI-C) (range 0-10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 8 |
Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 8 | Passive shoulder range of motion (ROM) of the affected shoulder assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Passive flexion measured by goniometer (0-180 degrees; higher degrees indicate better ROM), passive abduction by goniometer (0-180 degrees; higher degrees indicate better ROM), and passive external rotation at side by goniometer (-20 to 90 degrees; higher degrees indicate better ROM). Passive internal rotation is recorded as a 1-18 score based on the highest spinal level reached by the thumb tip behind the back (1-12 = T1-T12, 13-17 = L1-L5, 18 = sacral region or below; lower score indicates better ROM). Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0). | Week 0 (baseline) to Week 8 |
Change in SPADI Total Score from Baseline to Week 12 | Shoulder Pain and Disability Index (SPADI) total score (range 0-100, where 0 = no pain/disability and 100 = worst pain/disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 12 |
Change in QuickDASH Score from Baseline to Week 12 | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (range 0-100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 12 |
Change in EQ-5D-5L Index Score from Baseline to Week 12 | EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (index derived using the Chinese value set; range -0.391 to 1.000; higher scores indicate better health-related quality of life). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); positive change indicates improvement. | Baseline (Week 0) to Week 12 |
Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 12 | Worst shoulder pain in the past 24 hours measured by Numeric Rating Scale (NRS) (range 0-10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); negative change indicates improvement. | Baseline (Week 0) to Week 12 |
Change in Passive Shoulder ROM from Baseline to Week 12 | Passive shoulder range of motion (ROM) of the affected shoulder assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Passive flexion measured by goniometer (0-180 degrees; higher degrees indicate better ROM), passive abduction by goniometer (0-180 degrees; higher degrees indicate better ROM), and passive external rotation at side by goniometer (-20 to 90 degrees; higher degrees indicate better ROM). Passive internal rotation is recorded as a 1-18 score based on the highest spinal level reached by the thumb tip behind the back (1-12 = T1-T12, 13-17 = L1-L5, 18 = sacral region or below; lower score indicates better ROM). Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0). | Baseline (Week 0) to Week 12 |
Change in SPADI Total Score over 12 Weeks (Longitudinal) | Shoulder Pain and Disability Index (SPADI) total score (range 0-100, where 0 = no pain/disability and 100 = worst pain/disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in SPADI total score over 12 weeks will be evaluated; decreasing scores over time indicate improvement. | SPADI total score assessed at Weeks 0/2/4/8/12; longitudinal change over 12 weeks will be evaluated. |
Change in QuickDASH Score over 12 Weeks (Longitudinal) | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (range 0-100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in QuickDASH score over 12 weeks will be evaluated; decreasing scores over time indicate improvement. | Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12 |
Change in EQ-5D-5L Index Score over 12 Weeks (Longitudinal) | EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (index derived using the Chinese value set; range -0.391 to 1.000; higher scores indicate better health-related quality of life). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in EQ-5D-5L index over 12 weeks will be evaluated; increasing scores over time indicate improvement. | Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12 |
Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) over 12 Weeks (Longitudinal) | Worst shoulder pain in the past 24 hours measured by Numeric Rating Scale (NRS) (range 0-10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in NRS over 12 weeks will be evaluated; decreasing scores over time indicate improvement. | Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12 |
Change in Passive Shoulder Range of Motion (ROM) over 12 Weeks (Longitudinal) | Passive shoulder range of motion (ROM) of the affected shoulder assessed longitudinally at Weeks 0 (baseline), 2, 4, 8, and 12. Passive flexion measured by goniometer (0-180 degrees; higher degrees indicate better ROM), passive abduction by goniometer (0-180 degrees; higher degrees indicate better ROM), and passive external rotation at side by goniometer (-20 to 90 degrees; higher degrees indicate better ROM). Passive internal rotation is recorded as a 1-18 score based on the highest spinal level reached by the thumb tip behind the back (1-12 = T1-T12, 13-17 = L1-L5, 18 = sacral region or below; lower score indicates better ROM). Longitudinal change over 12 weeks will be evaluated. | Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Symptom duration ≤9 months; clinically diagnosed unilateral primary (idiopathic) frozen shoulder (including diabetes-associated frozen shoulder).
- Age 18 to 65 years.
- Worst shoulder pain in the past 24 hours (NRS-WP, 0-10) ≥4.
- Passive range of motion (ROM) limitation of the affected shoulder: compared with the contralateral normal shoulder, a decrease of ≥30° in at least two of the following three directions: forward flexion, abduction, and external rotation with the arm at the side.
- Radiographic exclusion of other shoulder pathology: Affected-shoulder anteroposterior (AP) radiograph excludes glenohumeral osteoarthritis, calcific tendinopathy, and other structural abnormalities; and axillary view and/or scapular Y (outlet) or transthoracic view excludes glenohumeral dislocation.
- Secondary frozen shoulder due to thyroid disease, cardiovascular disease, stroke, radiotherapy, prior neurosurgical or breast surgery, etc. (diabetes excluded from this item); or frozen shoulder secondary to major shoulder trauma requiring medical care (e.g., fracture, dislocation, rotator cuff tear).
- Confirmed or highly suspected full-thickness or massive rotator cuff tear causing functional pseudoparalysis (e.g., positive Jobe test with marked strength loss).
- Local infection of the affected shoulder or any contraindication to shoulder injection (e.g., uncorrected bleeding risk/coagulopathy).
- Contraindication to corticosteroid therapy (e.g., poorly controlled diabetes, systemic infection).
- Prior manipulation under anesthesia, arthroscopic capsular release, or open surgical release for frozen shoulder on the affected shoulder.
- Any corticosteroid treatment via any route within the past 3 months (including shoulder injection).
- Requires long-term or intermittent corticosteroid use for other conditions (e.g., autoimmune disease such as rheumatoid arthritis, acute asthma exacerbations).
- Bilateral frozen shoulder, or contralateral history of frozen shoulder not yet fully recovered.
- Conditions significantly affecting upper-limb function assessment or ability to perform rehabilitation (e.g., marked limb disability).
- Pregnant or breastfeeding.
- Lacks the cognitive ability to comply with study procedures.
- Does not reside in the region served by the participating hospital(s) (anticipated inability to complete follow-up).
- Compensation claims (e.g., work-related injury, traffic accident) or ongoing legal disputes/litigation.
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityContact central de l'étude
Contact: Bin Han, Medical Doctor, +86-13735402700, [email protected]
9 Centres de l'étude dans 1 pays
Shanghai Municipality
Yangpu District Central Hospital of Shanghai, Shanghai, Shanghai Municipality, 200082, China
Huaming Xue, Medical Doctor, Contact, +86-18964859835, [email protected]
Huaming Xue, Medical Doctor, Investigateur principal
Xuefeng Lei, Medical Master, Investigateur associé
Long Xue, Medical Master, Investigateur associé
Pas encore en recrutement
Zhejiang
The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310000, China
Yuepeng Xie, Medical Master, Contact, 86-15988115953, [email protected]
Yuepeng Xie, Medical Master, Investigateur principal
Yilei Jin, Bachelor of Science, Investigateur associé
Linfang Zhao, Medical Master, Investigateur associé
Pas encore en recrutement
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, China
Bin Han, Medical Doctor, Contact, +86-13735402700, [email protected]
Bin Han, Medical Doctor, Investigateur principal
Zhuolin Zhong, Medical Master, Investigateur associé
En recrutement
The First People's Hospital of Linping District, Hangzhou, Hangzhou, Zhejiang, 311199, China
Shenghua Wu, Medical Bachelor, Contact, +86-13372503239, [email protected]
Shenghua Wu, Medical Bachelor, Investigateur principal
Xiaobin Li, Medical Master, Investigateur associé
Xiufeng Kuang, Medical Master, Investigateur associé
Pas encore en recrutement
Huzhou Central Hospital, Huzhou, Zhejiang, 313000, China
Jianyou Li, Medical Doctor, Contact, +86-13857255511, [email protected]
Fengfeng Wu, Medical Doctor, Contact, +86-13567289166, [email protected]
Jianyou Li, Medical Doctor, Investigateur principal
Fengfeng Wu, Medical Doctor, Investigateur principal
Shiyun Shen, Medical Master, Investigateur associé
Yunsheng Han, Medical Bachelor, Investigateur associé
Qinguang Xu, Medical Doctor, Investigateur associé
Li Chen, Medical Master, Investigateur associé
Pas encore en recrutement
Pujiang People's Hospital, Jinhua, Zhejiang, 322200, China
Hongpeng Jian, Medical Bachelor, Contact, +86-18757991192, [email protected]
Hongpeng Jian, Medical Bachelor, Investigateur principal
Xiujuan Xu, Medical Bachelor, Investigateur associé
Muhan Hong, Medical Bachelor, Investigateur associé
Pas encore en recrutement
First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, 315020, China
Yunfeng Mi, Medical Doctor, Contact, +86-15968412281, [email protected]
Yunfeng Mi, Medical Doctor, Investigateur principal
Shaojie Zhou, Medical Bachelor, Investigateur associé
Yinfeng Hu, Medical Master, Investigateur associé
Pas encore en recrutement
Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group, Ningbo, Zhejiang, 315799, China
Lei Zhang, Medical Master, Contact, +86-18858222839, [email protected]
Lei Zhang, Medical Master, Investigateur principal
Yuqiong Gao, Medical Bachelor, Investigateur associé
Dong Sun, Medical Bachelor, Investigateur associé
Pas encore en recrutement
Shengzhou People's Hospital, Shanhu, Zhejiang, 312400, China
Haidong Zhou, Medical Master, Contact, +86-13858567997, [email protected]
Haidong Zhou, Medical Master, Investigateur principal
Lizhong Ren, Medical Bachelor, Investigateur associé
Yun Wang, Medical Master, Investigateur associé
Pas encore en recrutement