Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder

NCT05448794 | Unknown DMC

• 1 other identifier: C202105038 TSGHIRB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

• the Shoulder Pain and Disability Index score

  2 weeks

Study Arms (1)

evaluation prolotherapy for frozen shoulder

EXPERIMENTAL

This pilot study highlighted that prospective studies are required to prove its clinical application for FS and other conditions.

Other: injection

Interventions

injection OTHER

ultrasound-guided hydrodilatation with hypertonic Dextrose

evaluation prolotherapy for frozen shoulder

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \-

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Alberta, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Injections

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• CHIH-YA CHANG, MD

  Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan.

  STUDY DIRECTOR

Central Study Contacts

CHIH-YA CHANG, MD

CONTACT

+287923311; gradesboy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 7, 2022
• Study Start: August 20, 2021
• Primary Completion: June 22, 2022
• Study Completion: August 22, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after publish
• Access Criteria: we will discuss our all authors

Locations

TW (1)