An interventional study of injection in Frozen Shoulder, sponsored by Tri-Service General Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by Tri-Service General Hospital · Not applicable, Interventional, and Treatment
Objective: To determine whether ultrasound-guided Intra-Articular Hypertonic Dextrose and hydrodilatation improves pain and function in patients with frozen shoulder(FS)
Setting: a medical center hospital. Participants: Subjects with primary FS with shoulder pain more than 3 months. Interventions: Participants randomly be assigned into A and B group: group A received ultrasound-guided hydrodilatation with hypertonic Dextrose with a mixture of 2mL of 50%, 1mL of 2% lidocaine, and 6ml normative saline ; group B : ultrasound-guided hydrodilatation with 9 mL of normative saline and 1 mL of 2% lidocaine.
Main Outcome Measures: The primary outcome measure was the Shoulder Pain and Disability Index score. Secondary outcomes were the VAS of shoulder pain level, muscle power and angles of shoulder passive range of motion, including flexion, abduction, extension, external rotation, and internal rotation at pretreatment and weeks 2, 4, 8, 12 and 24 of post-treatment.
411 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 371 interventional studies indexed under Bursitis.
Browse Bursitis studies →Tri-Service General Hospital is the lead sponsor of 109 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants diagnosed with primary FS who had experienced shoulder pain for more than 6 months and a reduction > 30° in passive ROM of the affected shoulder in at least two directions (forward flexion, abduction, or external rotation) compared with the contralateral side were evaluated for eligibility. 23 Subjects with any degree of tear or calcified tendinitis of rotator cuff tendons, previous shoulder surgery, previous intra-articular injection for the affected shoulder within 3 months of the study; or any secondary FS caused by metabolic, rheumatic, infectious arthritis, stroke, tumor, shoulder fracture/dislocation, or acute cervical radiculopathy were excluded. 23
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This pilot study highlighted that prospective studies are required to prove its clinical application for FS and other conditions.
Other: injection
ultrasound-guided hydrodilatation with hypertonic Dextrose
the Shoulder Pain and Disability Index score
Time frame: 2 weeks
Plan to share: Yes — after publish, we could share our plan
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Tri-Service General Hospital