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

Tri-Service General Hospital1 site in 1 country60 target enrollmentAugust 20, 2021

ConditionsFrozen Shoulder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Frozen Shoulder
Sponsor: Tri-Service General Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: the Shoulder Pain and Disability Index score
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

August 20, 2021

End Date

August 22, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group