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

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adhesive Capsulitis

Intervention: Lidocaine + Kenalog (Drug); Lidocaine + Kenalog (Drug); Lidocaine (Drug); Lidocaine (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
April Armstrong, MD, Principal Investigator, Affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: 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.

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

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

Related publications:

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Arslan S, Celiker R. Comparison of the efficacy of local corticosteroid injection and physical therapy for the treatment of adhesive capsulitis. Rheumatol Int. 2001 Sep;21(1):20-3.

Bert J. Shoulder injections for subacromial bursitis. Minn Med. 1996 Sep;79(9):6.

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Starting date: August 2008
Last updated: February 25, 2015

Page last updated: August 23, 2015

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