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Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
This study has been withdrawn prior to enrollment.
(No enrollment)
Sponsor:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
April Armstrong, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00742846
First received: August 26, 2008
Last updated: February 25, 2015
Last verified: February 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Adhesive Capsulitis | Drug: Lidocaine + Kenalog Drug: Lidocaine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider) Primary Purpose: Treatment |
| Official Title: | Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis |
Resource links provided by NLM:
Further study details as provided by April Armstrong, Milton S. Hershey Medical Center:
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. [ Time Frame: 6-8 months ]
| Enrollment: | 0 |
| Study Start Date: | August 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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 subacromial space Local anesthetic and steroid in to the subacromial space Other Names:
|
|
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 |
|
Active Comparator: Group 4
The patient receives subacromial local anesthetic injection under fluoroscopy.
|
Drug: Lidocaine
5ml 1% Lidocaine alone into the subacromial space. subacromial local anesthetic injection |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00742846
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742846
Locations
| United States, Pennsylvania | |
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
| Principal Investigator: | April Armstrong, MD | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center |
More Information
Publications:
Richardson AT. Ernest Fletcher Lecture. The painful shoulder. Proc R Soc Med. 1975 Nov;68(11):731-6.
White, AET, Tuite, J.D. The accuracy and efficacy of shoulder injections in restrictive capsulitis. Journal of Orthopaedic Rheumatology 1996; 9: 37-40.
| Responsible Party: | April Armstrong, Associate Professor, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT00742846 History of Changes |
| Other Study ID Numbers: |
IRB #26378 |
| Study First Received: | August 26, 2008 |
| Last Updated: | February 25, 2015 |
Keywords provided by April Armstrong, Milton S. Hershey Medical Center:
|
Adhesive Capsulitis Subacromial injection Intraarticular injection |
Additional relevant MeSH terms:
|
Bursitis Periarthritis Rheumatic Diseases Joint Diseases Musculoskeletal Diseases Arthritis Connective Tissue Diseases Lidocaine Anesthetics, Local Anesthetics Triamcinolone hexacetonide Triamcinolone Acetonide Triamcinolone Triamcinolone diacetate Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 23, 2017