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NCT05448794 Clinical Trial

Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder

Frozen Shoulder Clinical Trial

Official title:
Efficacy of Ultrasound-guided Intra-Articular Hypertonic Dextrose(Prolotherapy) and Hydrodilatation for Frozen Shoulder

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05448794
Other study ID # C202105038 TSGHIRB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 20, 2021
Est. completion date August 22, 2022

Study information
Verified date July 2022
Source Tri-Service General Hospital
Contact CHIH-YA CHANG, MD
Phone +287923311
Email gradesboy@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: To determine whether ultrasound-guided Intra-Articular Hypertonic Dextrose and hydrodilatation improves pain and function in patients with frozen shoulder(FS)

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date August 22, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• injection
ultrasound-guided hydrodilatation with hypertonic Dextrose

Locations
Country Name City State
Taiwan Tri-Service General Hospital Taipei Alberta

Sponsors (1)
Lead Sponsor Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary the Shoulder Pain and Disability Index score 2 weeks
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