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Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder

Primary Purpose

Frozen Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
injection
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

evaluation prolotherapy for frozen shoulder

Arm Description

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

Outcomes

Primary Outcome Measures

the Shoulder Pain and Disability Index score

Secondary Outcome Measures

Full Information

First Posted
July 2, 2022
Last Updated
July 2, 2022
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05448794
Brief Title
Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder
Official Title
Efficacy of Ultrasound-guided Intra-Articular Hypertonic Dextrose(Prolotherapy) and Hydrodilatation for Frozen Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
August 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
evaluation prolotherapy for frozen shoulder
Arm Type
Experimental
Arm Description
This pilot study highlighted that prospective studies are required to prove its clinical application for FS and other conditions.
Intervention Type
Other
Intervention Name(s)
injection
Intervention Description
ultrasound-guided hydrodilatation with hypertonic Dextrose
Primary Outcome Measure Information:
Title
the Shoulder Pain and Disability Index score
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHIH-YA CHANG, MD
Phone
+287923311
Ext
13707
Email
gradesboy@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHIH-YA CHANG, MD
Organizational Affiliation
Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan.
Official's Role
Study Director
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
State/Province
Alberta
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIH-YA CHANG, MD
Phone
0287923311
Email
gradesboy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Efficacy of Prolotherapy and Hydrodilatation for Frozen Shoulder

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