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This study has been withdrawn prior to enrollment.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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 Penn State University:

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 ] [ Designated as safety issue: No ]

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:
  • Kenalog
  • Lidocaine
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:
  • Lidocaine
  • Kenalog
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

Other Name: Lidocaine
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

Other Name: Lidocaine

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Penn State University
Investigators
Principal Investigator: April Armstrong, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

Publications:
Dias R, Cutts S, Massoud S. "Frozen shoulder". BMJ. 2005 Dec 17;33(7350):1453-6. Review
Parlier-Cuau C, Champsaur P, Nizard R, Wybier M, Bacque MC, Laredo JD. "Percutaneous treatments of painful shoulder." Radiol Clin North Am. 1998 May;36(3):589-96.
Richardson, A.T. The painful shoulder. Proceedings of the Royal Society of Medicine 1975; 68(11): 731-736.
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, Penn State University
ClinicalTrials.gov Identifier: NCT00742846     History of Changes
Other Study ID Numbers: IRB #26378
Study First Received: August 26, 2008
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Adhesive Capsulitis
Subacromial injection
Intraarticular injection

Additional relevant MeSH terms:
Bursitis
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis
Anesthetics, Local
Lidocaine
Anesthetics
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014