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

Not Applicable

Withdrawn

• Conditions: Adhesive Capsulitis
• Interventions: Drug: Lidocaine + Kenalog; Drug: Lidocaine

• Registration Number: NCT00742846
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-25
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Lidocaine + Kenalog	The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.
Group 2	Lidocaine + Kenalog	The patient receives subacromial steroid and local anesthetic injection under fluoroscopy.
Group 3	Lidocaine	The patient receives intra-articular local anesthetic injection under fluoroscopy.
Group 4	Lidocaine	The patient receives subacromial local anesthetic injection under fluoroscopy.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States