search
Back to results

Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
steroid
Xylocaine 2 % Injectable Solution
Normal saline 2cc
normal saline 12cc
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring adhesive capsulitis

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1) age 35-65 years (to prevent the inclusion of patients with secondary AC), 2) onset of shoulder stiffness since over a month, and 3) limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation. Exclusion Criteria: ultrasound findings of rotator cuff tears, 2) plain radiography findings of significant glenohumeral joint arthritis, 3) accompanying cervical radiculopathy, 4) systemic inflammatory joint disease, 5) intraarticular injection into the glenohumeral joint within the past 3 months, 6) history of surgery on the affected shoulders, 7) regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, and 8) allergy to corticosteroid or lidocaine.

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low volume hydrodilatation

high volume hydrodilatation

Arm Description

patient received ultrasound-guided low volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +2cc normal saline)

patient received ultrasound-guided high volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +12cc normal saline)

Outcomes

Primary Outcome Measures

change in visual analog scale visual analog scale
visual analog scale

Secondary Outcome Measures

change in glenohumeral joint range of motion
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
change in Shoulder Pain And disability index
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
change in pain intensity
pain intensity was measured by visual analog scale.

Full Information

First Posted
April 5, 2023
Last Updated
April 5, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT05818111
Brief Title
Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
Official Title
Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

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

5. Study Description

Brief Summary
This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis
Detailed Description
adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis Design: a prospective, double-blinded, randomized, clinical trial Patient and methods: Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (10cc steroid hydrodilatation under ultrasonographic guidance ) and group 2 (20cc steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Shoulder Pain And Disability Index

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
adhesive capsulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low volume hydrodilatation
Arm Type
Experimental
Arm Description
patient received ultrasound-guided low volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +2cc normal saline)
Arm Title
high volume hydrodilatation
Arm Type
Active Comparator
Arm Description
patient received ultrasound-guided high volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +12cc normal saline)
Intervention Type
Drug
Intervention Name(s)
steroid
Intervention Description
triamcinolone 40mg 4cc
Intervention Type
Drug
Intervention Name(s)
Xylocaine 2 % Injectable Solution
Intervention Description
xylocaine 2% 4cc
Intervention Type
Drug
Intervention Name(s)
Normal saline 2cc
Intervention Description
normal saline 2cc
Intervention Type
Drug
Intervention Name(s)
normal saline 12cc
Intervention Description
normal saline 12cc
Primary Outcome Measure Information:
Title
change in visual analog scale visual analog scale
Description
visual analog scale
Time Frame
at 6, 12 wk
Secondary Outcome Measure Information:
Title
change in glenohumeral joint range of motion
Description
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
Time Frame
at 6, 12 wk
Title
change in Shoulder Pain And disability index
Description
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Time Frame
at 6, 12 wk
Title
change in pain intensity
Description
pain intensity was measured by visual analog scale.
Time Frame
at 6, 12 wk

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) age 35-65 years (to prevent the inclusion of patients with secondary AC), 2) onset of shoulder stiffness since over a month, and 3) limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation. Exclusion Criteria: ultrasound findings of rotator cuff tears, 2) plain radiography findings of significant glenohumeral joint arthritis, 3) accompanying cervical radiculopathy, 4) systemic inflammatory joint disease, 5) intraarticular injection into the glenohumeral joint within the past 3 months, 6) history of surgery on the affected shoulders, 7) regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, and 8) allergy to corticosteroid or lidocaine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia chi C Wang
Phone
0919527693
Email
jcwang0726@gmail.com
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia chi Wang
Phone
0919527693
Email
jcwang0726@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

We'll reach out to this number within 24 hrs