Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
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ClinicalTrials.gov Identifier: NCT00742846 |
Recruitment Status
:
Withdrawn
(No enrollment)
First Posted
: August 28, 2008
Last Update Posted
: February 27, 2015
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Adhesive Capsulitis | Drug: Lidocaine + Kenalog Drug: Lidocaine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

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:
|
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 |
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742846
United States, Pennsylvania | |
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | April Armstrong, MD | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center |
Publications:
Responsible Party: | April Armstrong, Associate Professor, Milton S. Hershey Medical Center |
ClinicalTrials.gov Identifier: | NCT00742846 History of Changes |
Other Study ID Numbers: |
IRB #26378 |
First Posted: | August 28, 2008 Key Record Dates |
Last Update Posted: | February 27, 2015 |
Last Verified: | February 2015 |
Keywords provided by April Armstrong, Milton S. Hershey Medical Center:
Adhesive Capsulitis Subacromial injection Intraarticular injection |
Additional relevant MeSH terms:
Bursitis Joint Diseases Musculoskeletal 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 |