Clinical trial
Effectiveness of Hydrodilatation With Hypertonic Dextrose Solution Injection After Intra-articular Steroid Injection for Frozen Shoulder Treatment: A Randomized Controlled Trial
Name
B202305141
Description
This study aims to investigate whether intra-articular corticosteroid injection, followed by hypertonic dextrose injection and shoulder joint capsular distension, is more effective than saline injection and shoulder joint capsular distension for treating frozen shoulder.
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-12-30
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
Intra-articular corticosteroid injection
Ultrasound-guided intra-articular corticosteroid injection treatment in the shoulder joint (2 ml SHINCORT INJ 10 MG/ML + 2 ml 2% Xylocaine) is performed once for the patient at the first week.
Arms:
Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose, Intra-articular corticosteroid injection and hydrodilation with Normal saline
hydrodilation with 15% hypertonic dextrose
The second round of ultrasound-guided shoulder joint injection is performed at the fourth week during the follow-up period and the injectate is 15% hypertonic dextrose (6 ml 50% Dextrose + 2 ml 2% Xylocaine + 12 ml normal saline, totaling 20 ml).
Arms:
Intra-articular corticosteroid injection and hydrodilation with 15% hypertonic dextrose
hydrodilation with Normal saline
The second round of ultrasound-guided shoulder joint injection is performed at the fourth week during the follow-up period and the injectate is Normal saline (2 ml 2% Xylocaine + 18 ml normal saline, totaling 20 ml).
Arms:
Intra-articular corticosteroid injection and hydrodilation with Normal saline
Size
60
Primary endpoint
Visual Analogue Scale (VAS)
the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months
Eligibility criteria
Inclusion Criteria:
1. The diagnosis of frozen shoulder is determined by physicians through an evaluation of the patient's medical history, physical examination, and assessment of X-ray and ultrasound reports.
2. The duration of symptoms should be more than 3 months.
3. There should be a decrease of at least 30 degrees in a minimum of two shoulder joint angles (shoulder flexion, abduction, and external rotation) compared to the corresponding angles on the healthy side.
Exclusion Criteria:
1. Ultrasound examination of the shoulder muscles must not reveal a complete tear or massive tear of the rotator cuff tendon or evidence of calcific tendinitis.
2. Presence of systemic rheumatic disease.
3. History of previous shoulder fracture or undergoing surgical intervention.
4. Receipt of shoulder joint injections within the last 3 months.
5. Acute cervical nerve root compression.
6. Current status of pregnancy or breastfeeding.
7. Poorly controlled diabetes (since intravenous glucose injection may cause temporary blood sugar elevation).
8. Patients with a history of cancer.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-12-12
1 organization
3 products
1 indication
Organization
Tri-Service General HospitalIndication
Adhesive CapsulitisProduct
Hydrodilation