Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder
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|ClinicalTrials.gov Identifier: NCT03678038|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adhesive Capsulitis||Drug: triamcinolone, shincort||Not Applicable|
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 for at least 3 months 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder|
|Actual Study Start Date :||September 28, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Experimental: rotator interval injection
patient received ultrasound-guided steroid injection via rotator interval
Drug: triamcinolone, shincort
via rotator interval.
Active Comparator: posterior recess injection
patient received ultrasound-guided steroid injection via posterior recess
Drug: triamcinolone, shincort
via rotator interval posterior recess
- constant shoulder score [ Time Frame: 12 weeks ]the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength
- pain intensity [ Time Frame: 0, 6, 12 weeks ]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.
- Shoulder Pain And disability index [ Time Frame: 0, 6, 12 weeks ]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.
- glenohumeral joint range of motion [ Time Frame: 0, 6, 12 weeks ]Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678038
|Contact: Jia chi Wangemail@example.com|
|Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 241|
|Contact: Jia c Wang, MD 919527693 firstname.lastname@example.org|