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

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00742846
• Other study ID #: IRB #26378
• Status: Withdrawn
• Phase: N/A
• First received: August 26, 2008
• Last updated: February 25, 2015
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Periarthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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

White, AET, Tuite, J.D. The accuracy and efficacy of shoulder injections in restrictive capsulitis. Journal of Orthopaedic Rheumatology 1996; 9: 37-40.

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6-8 months	No