Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00742846

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Milton S. Hershey Medical Center · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGLidocaine + Kenalog5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint Intra-articular injection with local anesthetic and steroid
DRUGLidocaine + Kenalog5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space Local anesthetic and steroid in to the subacromial space
DRUGLidocaine5ml 1% Lidocaine alone into the shoulder joint. intra-articular local anesthetic injection
DRUGLidocaine5ml 1% Lidocaine alone into the subacromial space. subacromial local anesthetic injection

Timeline

Start date
2008-08-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2008-08-28
Last updated
2015-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00742846. Inclusion in this directory is not an endorsement.