Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
Steroid and Sodium Hyaluronate Hydrodilatation
1 other identifier
interventional
84
1 country
1
Brief Summary
This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedStudy Start
First participant enrolled
May 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2024
CompletedJune 18, 2023
April 1, 2023
11 months
April 5, 2023
June 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
change in pain intensity
pain intensity was measured by visual analog scale (0-10)
0, 6, 12weeks
Secondary Outcomes (2)
change in Shoulder Pain And disability index
0, 6, 12 weeks
change in glenohumeral joint range of motion
0, 6, 12weeks
Study Arms (2)
hydrodilatation with steroid
EXPERIMENTALpatient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine
hydrodilatation with hyaluronic acid and steroid
ACTIVE COMPARATORpatient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine
Interventions
Ultrasound guided injection using 3ml of Sodium Hyaluronate
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide
Eligibility Criteria
You may qualify if:
- age 35-65 years
- onset of shoulder stiffness since over a month
- 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.
You may not qualify if:
- ultrasound findings of rotator cuff tears,
- plain radiography findings of significant glenohumeral joint arthritis,
- accompanying cervical radiculopathy,
- systemic inflammatory joint disease,
- intraarticular injection into the glenohumeral joint within the past 3 months
- history of surgery on the affected shoulders,
- regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids,
- allergy to corticosteroid or lidocaine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double (Participant, Outcomes Assessor)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2023
First Posted
May 17, 2023
Study Start
May 18, 2023
Primary Completion
April 6, 2024
Study Completion
April 6, 2024
Last Updated
June 18, 2023
Record last verified: 2023-04