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

Milton S. Hershey Medical Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Adhesive Capsulitis

Interventions

Lidocaine + KenalogDRUG

5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint Intra-articular injection with local anesthetic and steroid

Lidocaine + KenalogDRUG

5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space Local anesthetic and steroid in to the subacromial space

LidocaineDRUG

5ml 1% Lidocaine alone into the shoulder joint. intra-articular local anesthetic injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 6-8 months

Data from ClinicalTrials.gov

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