Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis
NCT ID: NCT00742846
Last Updated: 2015-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2008-08-31
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1
The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.
Lidocaine + Kenalog
5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint
Intra-articular injection with local anesthetic and steroid
Group 2
The patient receives subacromial steroid and local anesthetic injection under fluoroscopy.
Lidocaine + Kenalog
5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space
Local anesthetic and steroid in to the subacromial space
Group 3
The patient receives intra-articular local anesthetic injection under fluoroscopy.
Lidocaine
5ml 1% Lidocaine alone into the shoulder joint.
intra-articular local anesthetic injection
Group 4
The patient receives subacromial local anesthetic injection under fluoroscopy.
Lidocaine
5ml 1% Lidocaine alone into the subacromial space.
subacromial local anesthetic injection
Interventions
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Lidocaine + Kenalog
5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint
Intra-articular injection with local anesthetic and steroid
Lidocaine + Kenalog
5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space
Local anesthetic and steroid in to the subacromial space
Lidocaine
5ml 1% Lidocaine alone into the shoulder joint.
intra-articular local anesthetic injection
Lidocaine
5ml 1% Lidocaine alone into the subacromial space.
subacromial local anesthetic injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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April Armstrong
Associate Professor
Principal Investigators
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April Armstrong, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Locations
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Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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Alvado A, Pelissier J, Benaim C, Petiot S, Herisson C. [Physical therapy of frozen shoulder: literature review]. Ann Readapt Med Phys. 2001 Mar;44(2):59-71. doi: 10.1016/s0168-6054(00)00062-3. French.
Andrieu V, Dromer C, Fourcade D, Zabraniecki L, Ginesty E, Marc V, Railhac JJ, Fournie 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. doi: 10.1007/s002960100127.
Bert J. Shoulder injections for subacromial bursitis. Minn Med. 1996 Sep;79(9):6. No abstract available.
Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont 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. doi: 10.1002/art.10954.
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. doi: 10.1097/01.phm.0000184158.85689.5e.
Dacre JE, Beeney N, Scott DL. Injections and physiotherapy for the painful stiff shoulder. Ann Rheum Dis. 1989 Apr;48(4):322-5. doi: 10.1136/ard.48.4.322.
Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
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. doi: 10.1016/j.annrmp.2005.09.001. 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. doi: 10.1191/026921598673772420.
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. doi: 10.1136/bmj.287.6402.1339.
Kivimaki J, Pohjolainen T. Manipulation under anesthesia for frozen shoulder with and without steroid injection. Arch Phys Med Rehabil. 2001 Sep;82(9):1188-90. doi: 10.1053/apmr.2001.24169.
Loyd JA, Loyd HM. Adhesive capsulitis of the shoulder: arthrographic diagnosis and treatment. South Med J. 1983 Jul;76(7):879-83. doi: 10.1097/00007611-198307000-00016.
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. doi: 10.1016/s0033-8389(05)70047-6.
Richardson AT. Ernest Fletcher Lecture. The painful shoulder. Proc R Soc Med. 1975 Nov;68(11):731-6. doi: 10.1177/003591577506801137. No abstract available.
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. doi: 10.1093/rheumatology/keh535. 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.
White, AET, Tuite, J.D. The accuracy and efficacy of shoulder injections in restrictive capsulitis. Journal of Orthopaedic Rheumatology 1996; 9: 37-40.
Other Identifiers
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IRB #26378
Identifier Type: -
Identifier Source: org_study_id
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