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Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
normal saline
(Sodium Hyaluronate (Hyruan One , LG)
lidocaine hydrochloride
Triamcinolone Acetonide
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

Eligibility Criteria

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

Inclusion Criteria: age 35-65 years onset of shoulder stiffness since over a month 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, plain radiography findings of significant glenohumeral joint arthritis, accompanying cervical radiculopathy, systemic inflammatory joint disease, intraarticular injection into the glenohumeral joint within the past 3 months history of surgery on the affected shoulders, regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, 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

hydrodilatation with steroid

hydrodilatation with hyaluronic acid and steroid

Arm Description

patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine

patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine

Outcomes

Primary Outcome Measures

change in pain intensity
pain intensity was measured by visual analog scale (0-10)

Secondary Outcome Measures

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 glenohumeral joint range of motion
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.

Full Information

First Posted
April 5, 2023
Last Updated
June 16, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05861570
Brief Title
Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
Official Title
Steroid and Sodium Hyaluronate Hydrodilatation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
April 6, 2024 (Anticipated)
Study Completion Date
April 6, 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

5. Study Description

Brief Summary
This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.
Detailed Description
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 (hydrodilatation with steroid ) and group 2 (hydrodilatation with hyaluronic acid and steroid). 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hydrodilatation with steroid
Arm Type
Experimental
Arm Description
patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine
Arm Title
hydrodilatation with hyaluronic acid and steroid
Arm Type
Active Comparator
Arm Description
patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Ultrasound guided injection using 3ml normal saline
Intervention Type
Drug
Intervention Name(s)
(Sodium Hyaluronate (Hyruan One , LG)
Intervention Description
Ultrasound guided injection using 3ml of Sodium Hyaluronate
Intervention Type
Drug
Intervention Name(s)
lidocaine hydrochloride
Intervention Description
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide
Primary Outcome Measure Information:
Title
change in pain intensity
Description
pain intensity was measured by visual analog scale (0-10)
Time Frame
0, 6, 12weeks
Secondary Outcome Measure Information:
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
0, 6, 12 weeks
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
0, 6, 12weeks

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: age 35-65 years onset of shoulder stiffness since over a month 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, plain radiography findings of significant glenohumeral joint arthritis, accompanying cervical radiculopathy, systemic inflammatory joint disease, intraarticular injection into the glenohumeral joint within the past 3 months history of surgery on the affected shoulders, regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids, allergy to corticosteroid or lidocaine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia chi 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

Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

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