Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder

NCT ID: NCT05448794

Last Updated: 2022-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2022-08-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Frozen Shoulder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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evaluation prolotherapy for frozen shoulder

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

Group Type EXPERIMENTAL

injection

Intervention Type OTHER

ultrasound-guided hydrodilatation with hypertonic Dextrose

Interventions

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injection

ultrasound-guided hydrodilatation with hypertonic Dextrose

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chih-Ya Chang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CHIH-YA CHANG, MD

Role: STUDY_DIRECTOR

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

Locations

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Tri-Service General Hospital

Taipei, Alberta, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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CHIH-YA CHANG, MD

Role: CONTACT

+287923311 ext. 13707

Facility Contacts

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CHIH-YA CHANG, MD

Role: primary

0287923311

Other Identifiers

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C202105038 TSGHIRB

Identifier Type: -

Identifier Source: org_study_id

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