Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
Primary Purpose
Adhesive Capsulitis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lidocaine + Kenalog
Lidocaine + Kenalog
Lidocaine
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive Capsulitis, Subacromial injection, Intraarticular injection
Eligibility Criteria
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
Sites / Locations
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.
The patient receives subacromial steroid and local anesthetic injection under fluoroscopy.
The patient receives intra-articular local anesthetic injection under fluoroscopy.
The patient receives subacromial local anesthetic injection under fluoroscopy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00742846
First Posted
August 26, 2008
Last Updated
February 25, 2015
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00742846
Brief Title
Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
Official Title
Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No enrollment
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive Capsulitis, Subacromial injection, Intraarticular injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
The patient receives subacromial steroid and local anesthetic injection under fluoroscopy.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
The patient receives intra-articular local anesthetic injection under fluoroscopy.
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
The patient receives subacromial local anesthetic injection under fluoroscopy.
Intervention Type
Drug
Intervention Name(s)
Lidocaine + Kenalog
Other Intervention Name(s)
Kenalog, Lidocaine
Intervention Description
5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint
Intra-articular injection with local anesthetic and steroid
Intervention Type
Drug
Intervention Name(s)
Lidocaine + Kenalog
Other Intervention Name(s)
Lidocaine, Kenalog
Intervention Description
5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space
Local anesthetic and steroid in to the subacromial space
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
5ml 1% Lidocaine alone into the shoulder joint.
intra-articular local anesthetic injection
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
5ml 1% Lidocaine alone into the subacromial space.
subacromial local anesthetic injection
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April Armstrong, MD
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
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Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
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