Back to resultsSteroid Injection for Adhesive Capsulitis
Primary Purpose
Adhesive Capsulitis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Triamcinolone Acetonide
lidocaine hydrochloride
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of adhesive capsulitis
- a duration of complaints more than 3 months
- a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.
Exclusion Criteria:
- prior manipulation of the affected shoulder under anesthesia;
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
- neurologic deficits affecting shoulder function in normal daily activities;
- shoulder pain caused by cervical radiculopathy
- a history of drug allergy to hyaluronic acid;
- pregnancy or lactation;
- received injection into the affected shoulder during the preceding 3 months
Sites / Locations
- Taipei veteran general hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
low dose steroid
high dose steroid
Arm Description
patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS
patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS
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
NCT ID
NCT04364425
First Posted
April 20, 2020
Last Updated
May 13, 2020
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04364425
Brief Title
Steroid Injection for Adhesive Capsulitis
Official Title
Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (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 low dose steroid with high dose 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 low dose steroid ) and group 2 (hydrodilatation with high dose 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, Constant shoulder score, 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
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low dose steroid
Arm Type
Experimental
Arm Description
patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS
Arm Title
high dose steroid
Arm Type
Active Comparator
Arm Description
patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
triamcinolone acetonide 10mg/ml (Shincort, YSP, Taiwan)
Intervention Description
ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
lidocaine hydrochloride
Other Intervention Name(s)
lidocaine hydrochloride (Xylocaine)
Intervention Description
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Ultrasound guided injection using 15ml or 12 ml of normal saline
Primary Outcome Measure Information:
Title
change in pain intensity
Description
pain intensity was measured by visual analog scale (0-10)
Time Frame
0, 6, 12 wks.
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 wks.
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, 12 wks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of adhesive capsulitis
a duration of complaints more than 3 months
a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.
Exclusion Criteria:
prior manipulation of the affected shoulder under anesthesia;
other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,osteoporosis, or malignancies in the shoulder region);
neurologic deficits affecting shoulder function in normal daily activities;
shoulder pain caused by cervical radiculopathy
a history of drug allergy to hyaluronic acid;
pregnancy or lactation;
received injection into the affected shoulder during the preceding 3 months
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 veteran general hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia chi Wang
Email
jcwang0726@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Steroid Injection for Adhesive Capsulitis
We'll reach out to this number within 24 hrs