Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

Study Overview
=================
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.

Official Title
-----------------
Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder

Conditions
-----------------
Adhesive Capsulitis

Intervention / Treatment
-----------------
* Drug: Triamcinolone (Shincort) injection to rotator interval
* Drug: Triamcinolone (Shincort) injection to posterior glenuhumeral recess


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rotator interval injection<br>patient received ultrasound-guided steroid injection via rotator interval | Drug: Triamcinolone (Shincort) injection to rotator interval<br>* via rotator interval.<br>|
| Active Comparator: posterior recess injection<br>patient received ultrasound-guided steroid injection via posterior recess | Drug: Triamcinolone (Shincort) injection to posterior glenuhumeral recess<br>* via posterior glenuhumeral recess<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline | 
| glenohumeral joint range of motion | Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position | Change at baseline, 6 weeks, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adhesive capsulitis