Steroid Injection for Adhesive Capsulitis
Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis
1 other identifier
interventional
80
1 country
1
Brief Summary
This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose 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 2020
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 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedStudy Start
First participant enrolled
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedMay 14, 2020
May 1, 2020
1.3 years
April 20, 2020
May 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
change in pain intensity
pain intensity was measured by visual analog scale (0-10)
0, 6, 12 wks.
Secondary Outcomes (2)
change in Shoulder Pain And disability index
0, 6, 12 wks.
change in glenohumeral joint range of motion
0, 6, 12 wks.
Study Arms (2)
low dose steroid
EXPERIMENTALpatient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS
high dose steroid
ACTIVE COMPARATORpatient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS
Interventions
ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
Ultrasound guided injection using 15ml or 12 ml of normal saline
Eligibility Criteria
You may qualify if:
- clinical diagnosis of adhesive capsulitis
- a duration of complaints more than 3 months
- a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.
You may not qualify if:
- prior manipulation of the affected shoulder under anesthesia;
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
- neurologic deficits affecting shoulder function in normal daily activities;
- shoulder pain caused by cervical radiculopathy
- a history of drug allergy to hyaluronic acid;
- pregnancy or lactation;
- received injection into the affected shoulder during the preceding 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei veteran general hospital
Taipei, Taiwan
Related Publications (1)
Wang JC, Hsu PC, Wang KA, Wu WT, Chang KV. Comparative Effectiveness of Corticosteroid Dosages for Ultrasound-Guided Glenohumeral Joint Hydrodilatation in Adhesive Capsulitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):745-752. doi: 10.1016/j.apmr.2022.11.007. Epub 2022 Dec 12.
PMID: 36521580DERIVED
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 28, 2020
Study Start
May 4, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
May 14, 2020
Record last verified: 2020-05