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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
April Armstrong, Penn State University
ClinicalTrials.gov Identifier:
NCT00742846
First received: August 26, 2008
Last updated: May 23, 2012
Last verified: May 2012

August 26, 2008
May 23, 2012
August 2008
December 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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: When enrollment is completed. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00742846 on ClinicalTrials.gov Archive Site
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Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Adhesive Capsulitis
  • Drug: Lidocaine + Kenalog

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

    Intra-articular injection with local anesthetic and steroid

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

    5ml 1% Lidocaine alone into the shoulder joint.

    intra-articular local anesthetic injection

    Other Name: Lidocaine
  • Drug: Lidocaine

    5ml 1% Lidocaine alone into the subacromial space.

    subacromial local anesthetic injection

    Other Name: Lidocaine
  • Active Comparator: Group 1
    The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.
    Intervention: Drug: Lidocaine + Kenalog
  • Active Comparator: Group 2
    The patient receives subacromial steroid and local anesthetic injection under fluoroscopy.
    Intervention: Drug: Lidocaine + Kenalog
  • Active Comparator: Group 3
    The patient receives intra-articular local anesthetic injection under fluoroscopy.
    Intervention: Drug: Lidocaine
  • Active Comparator: Group 4
    The patient receives subacromial local anesthetic injection under fluoroscopy.
    Intervention: Drug: Lidocaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00742846
IRB #26378
No
April Armstrong, Penn State University
Penn State University
Not Provided
Principal Investigator: April Armstrong, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Penn State University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP