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

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:

Drug Information available for: Triamcinolone diacetate Lidocaine hydrochloride Triamcinolone acetonide Triamcinolone Lidocaine Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by 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 ] [ 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
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)
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

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:

Alvado A, Pélissier J, Bénaim C, Petiot S, Hérisson C. [Physical therapy of frozen shoulder: literature review]. Ann Readapt Med Phys. 2001 Mar;44(2):59-71. French.

Andrieu V, Dromer C, Fourcade D, Zabraniecki L, Ginesty E, Marc V, Railhac JJ, Fournié B. Adhesive capsulitis of the shoulder: therapeutic contribution of subacromial bursography. Rev Rhum Engl Ed. 1998 Dec;65(12):771-7.

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.

Carette S, Moffet H, Tardif J, Bessette L, Morin F, Frémont P, Bykerk V, Thorne C, Bell M, Bensen W, Blanchette C. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003 Mar;48(3):829-38.

Chen MJ, Lew HL, Hsu TC, Tsai WC, Lin WC, Tang SF, Lee YC, Hsu RC, Chen CP. Ultrasound-guided shoulder injections in the treatment of subacromial bursitis. Am J Phys Med Rehabil. 2006 Jan;85(1):31-5.

Dacre JE, Beeney N, Scott DL. Injections and physiotherapy for the painful stiff shoulder. Ann Rheum Dis. 1989 Apr;48(4):322-5.

Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. Review.

Fouquet B, Griffoul I, Borie MJ, Roger R, Bonnin B, Metivier JC, Pellieux S. [Adhesive capsulitis: evaluation of a treatment coupling capsular distension and intensive rehabilitation]. Ann Readapt Med Phys. 2006 Mar;49(2):68-74. Epub 2005 Sep 27. French.

de Jong BA, Dahmen R, Hogeweg JA, Marti RK. Intra-articular triamcinolone acetonide injection in patients with capsulitis of the shoulder: a comparative study of two dose regimens. Clin Rehabil. 1998 Jun;12(3):211-5.

Hollingworth GR, Ellis RM, Hattersley TS. Comparison of injection techniques for shoulder pain: results of a double blind, randomised study. Br Med J (Clin Res Ed). 1983 Nov 5;287(6402):1339-41.

Kivimäki J, Pohjolainen T. Manipulation under anesthesia for frozen shoulder with and without steroid injection. Arch Phys Med Rehabil. 2001 Sep;82(9):1188-90.

Loyd JA, Loyd HM. Adhesive capsulitis of the shoulder: arthrographic diagnosis and treatment. South Med J. 1983 Jul;76(7):879-83.

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. Review.

Richardson AT. Ernest Fletcher Lecture. The painful shoulder. Proc R Soc Med. 1975 Nov;68(11):731-6.

Rizk TE, Pinals RS, Talaiver AS. Corticosteroid injections in adhesive capsulitis: investigation of their value and site. Arch Phys Med Rehabil. 1991 Jan;72(1):20-2.

Ryans I, Montgomery A, Galway R, Kernohan WG, McKane R. A randomized controlled trial of intra-articular triamcinolone and/or physiotherapy in shoulder capsulitis. Rheumatology (Oxford). 2005 Apr;44(4):529-35. Epub 2005 Jan 18.

Tallia AF, Cardone DA. Diagnostic and therapeutic injection of the shoulder region. Am Fam Physician. 2003 Mar 15;67(6):1271-8. Review.

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
Health Authority:	United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:


Adhesive Capsulitis Subacromial injection Intraarticular injection

Additional relevant MeSH terms:


Periarthritis Rheumatic Diseases Bursitis Arthritis Joint Diseases Musculoskeletal Diseases 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

Periarthritis
Rheumatic Diseases
Bursitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
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 September 27, 2016