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
• Status: Recruiting
• Phase: N/A
• 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
• 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 -

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

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