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

February 25, 2015 updated by: April Armstrong, Milton S. Hershey Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.
Drug: Lidocaine + Kenalog

5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint

Intra-articular injection with local anesthetic and steroid

Other Names:
  • Lidocaine
  • Kenalog
Drug: Lidocaine + Kenalog

5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space

Local anesthetic and steroid in to the subacromial space

Other Names:
  • Lidocaine
  • Kenalog
Active Comparator: Group 2
The patient receives subacromial steroid and local anesthetic injection under fluoroscopy.
Drug: Lidocaine + Kenalog

5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint

Intra-articular injection with local anesthetic and steroid

Other Names:
  • Lidocaine
  • Kenalog
Drug: Lidocaine + Kenalog

5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space

Local anesthetic and steroid in to the subacromial space

Other Names:
  • Lidocaine
  • Kenalog
Active Comparator: Group 3
The patient receives intra-articular local anesthetic injection under fluoroscopy.
Drug: Lidocaine

5ml 1% Lidocaine alone into the shoulder joint.

intra-articular local anesthetic injection

Drug: Lidocaine

5ml 1% Lidocaine alone into the subacromial space.

subacromial local anesthetic injection
Active Comparator: Group 4
The patient receives subacromial local anesthetic injection under fluoroscopy.
Drug: Lidocaine

5ml 1% Lidocaine alone into the shoulder joint.

intra-articular local anesthetic injection

Drug: Lidocaine

5ml 1% Lidocaine alone into the subacromial space.

subacromial local anesthetic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 6-8 months
6-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: April Armstrong, MD, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #26378

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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