Clinical trial

Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Name
2022-12-001B
Description
This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis
Trial arms
Trial start
2023-01-31
Estimated PCD
2024-01-31
Trial end
2024-02-01
Status
Recruiting
Treatment
steroid
triamcinolone 40mg 4cc
Arms:
high volume hydrodilatation, low volume hydrodilatation
Xylocaine 2 % Injectable Solution
xylocaine 2% 4cc
Arms:
high volume hydrodilatation, low volume hydrodilatation
Normal saline 2cc
normal saline 2cc
Arms:
low volume hydrodilatation
normal saline 12cc
normal saline 12cc
Arms:
high volume hydrodilatation
Size
86
Primary endpoint
change in visual analog scale visual analog scale
at 6, 12 wk
Eligibility criteria
Inclusion Criteria: 1) age 35-65 years (to prevent the inclusion of patients with secondary AC), 2) onset of shoulder stiffness since over a month, and 3) limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation. Exclusion Criteria: 1. ultrasound findings of rotator cuff tears, 2) plain radiography findings of significant glenohumeral joint arthritis, 3) accompanying cervical radiculopathy, 4) systemic inflammatory joint disease, 5) intraarticular injection into the glenohumeral joint within the past 3 months, 6) history of surgery on the affected shoulders, 7) regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, and 8) allergy to corticosteroid or lidocaine.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 86, 'type': 'ESTIMATED'}}
Updated at
2023-04-18

1 organization

3 products

1 drug

1 indication

Indication
Frozen Shoulder
Product
Xylocaine