Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis

Study Overview
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Brief Summary
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The primary objective is to compare the clinical outcomes of patients with a clinical diagnosis of Adhesive Capsulitis who receive intra-articular versus subacromial steroid injections. The secondary objective is to verify that steroid injections in combination with physical therapy lead to more favorable outcomes than local anesthetic injections in combination with physical therapy.

Detailed Description
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Current treatment for Adhesive Capsulitis involves physical therapy. Steroid injections have not been shown to be as effective alone without the physical therapy. However, there are multiple studies that document the benefit of adding a steroid injection to the physical therapy. After a review of the literature, there are studies that compare different dosages of intra-articular steroid injections,value and site of the injections, and accuracy of clinical injections. There are currently no studies that compare the results after intra-articular versus subacromial injections in combination with physical therapy. This study would help us determine if location of the injection is a major factor in regaining motion. If it is significantly important to be intra-articular with the steroid, than it may be important to send patients for fluoroscopic guided injections routinely rather than risk the chance of not being within the joint.

Official Title
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Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Drug: Lidocaine + Kenalog
* Drug: Lidocaine + Kenalog
* Drug: Lidocaine
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet clinical diagnosis of primary Adhesive Capsulitis Restriction in abduction to less than 130 degrees 50% reduction in external rotation as compared with the contralateral side An intact rotator cuff Between 18-75 years of age Exclusion Criteria: Previous shoulder capsular surgery History of steroid injection(s) into affected shoulder Inability to provide informed consent Iodinated contrast dye allergy Allergy to lidocaine Other suspected shoulder pathology (i.e., tumor, rotator cuff rupture. infection, arthritis) Known bleeding diathesis Cervical spine pathology History of trauma to the shoulder Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy. | Drug: Lidocaine + Kenalog<br>* 5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint Intra-articular injection with local anesthetic and steroid<br>* Other names: Lidocaine;|
| Active Comparator: Group 2<br>The patient receives subacromial steroid and local anesthetic injection under fluoroscopy. | Drug: Lidocaine + Kenalog<br>* 5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space Local anesthetic and steroid in to the subacromial space<br>* Other names: Kenalog;|
| Active Comparator: Group 3<br>The patient receives intra-articular local anesthetic injection under fluoroscopy. | Drug: Lidocaine<br>* 5ml 1% Lidocaine alone into the shoulder joint. intra-articular local anesthetic injection<br>|
| Active Comparator: Group 4<br>The patient receives subacromial local anesthetic injection under fluoroscopy. | Drug: Lidocaine<br>* 5ml 1% Lidocaine alone into the subacromial space. subacromial local anesthetic injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary goal of this study is to document the return of shoulder motion and resolution of adhesive capsulitis after intra-articular versus subacromial steroid injections versus anesthetic injections in combination with physical therapy. |  | 6-8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesive Capsulitis, Subacromial injection, Intraarticular injection