Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder
Primary Purpose
Adhesive Capsulitis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Triamcinolone (Shincort) injection to rotator interval
Triamcinolone (Shincort) injection to posterior glenuhumeral recess
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring adhesive capsulitis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of frozen shoulder by physical examination and ultrasonography
Exclusion Criteria:
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,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 xylocaine or corticosteroid
- pregnancy or lactation;
- received injection into the affected shoulder during the preceding 3 months
- history of surgeries on the affected shoulders
- Secondary frozen shoulder
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
rotator interval injection
posterior recess injection
Arm Description
patient received ultrasound-guided steroid injection via rotator interval
patient received ultrasound-guided steroid injection via posterior recess
Outcomes
Primary Outcome Measures
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.function. The score is divided into four sections: pain, activity of daily living, ROM and strength
Secondary Outcome Measures
pain intensity
pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.
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
NCT03678038
First Posted
September 9, 2018
Last Updated
April 27, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03678038
Brief Title
Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder
Official Title
Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)
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 via posterior approach versus rotator interval approach for treating patients with 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 rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.
Design: a prospective, single-blinded, randomized, clinical trial
Patient and methods:
Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided rotator interval injection ) and group 2 (ultrasound guided 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, Constant shoulder score, and 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
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rotator interval injection
Arm Type
Experimental
Arm Description
patient received ultrasound-guided steroid injection via rotator interval
Arm Title
posterior recess injection
Arm Type
Active Comparator
Arm Description
patient received ultrasound-guided steroid injection via posterior recess
Intervention Type
Drug
Intervention Name(s)
Triamcinolone (Shincort) injection to rotator interval
Intervention Description
via rotator interval.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone (Shincort) injection to posterior glenuhumeral recess
Intervention Description
via posterior glenuhumeral recess
Primary Outcome Measure Information:
Title
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.function. The score is divided into four sections: pain, activity of daily living, ROM and strength
Time Frame
Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Secondary Outcome Measure Information:
Title
pain intensity
Description
pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.
Time Frame
Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Title
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
Change at baseline, 6 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of frozen shoulder by physical examination and ultrasonography
Exclusion Criteria:
other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,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 xylocaine or corticosteroid
pregnancy or lactation;
received injection into the affected shoulder during the preceding 3 months
history of surgeries on the affected shoulders
Secondary frozen shoulder
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
241
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder
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