Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder

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

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

Study Overview

• Status: Recruiting
• Conditions: Frozen Shoulder
• Intervention / Treatment: Other: injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CHIH-YA CHANG, MD; Phone Number: 13707 +287923311; Email: gradesboy@gmail.com

Study Locations

• Taiwan
  • Alberta
    • Taipei, Alberta, Taiwan
      • Recruiting
      • Tri-Service General Hospital
      • Contact: CHIH-YA CHANG, MD; Phone Number: 0287923311; Email: gradesboy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: evaluation prolotherapy for frozen shoulder; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the Shoulder Pain and Disability Index score	2 weeks

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Study Director: CHIH-YA CHANG, MD, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2021
• Primary Completion (ACTUAL): June 22, 2022
• Study Completion (ANTICIPATED): August 22, 2022

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (ACTUAL): July 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: C202105038 TSGHIRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after publish, we could share our plan
• IPD Sharing Time Frame: after publish
• IPD Sharing Access Criteria: we will discuss our all authors
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No