Corticosteroids and / or Arthrographic Distention in the Treatment of Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

— CADAC  

Official title:

A Prospective Randomized 3-arm Trial Comparing Intra-articular Corticosteroid Injection vs Arthrographic Distention vs Arthrographic Distention Plus Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01983527
• Other study ID #: CADAC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 7, 2013
• Last updated: November 13, 2013
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2013
• Source: Imelda Hospital, Bonheiden
• Contact: Rolf Symons, MD
• Phone: +32(0)15/50.62.31
• Email: rolf.symons[@]imelda.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

Arthrographic distention of the shoulder joint is an increasingly popular treatment option in the management of patients with frozen shoulder. Most have included the intra-articular injection of a corticosteroid as part of the procedure, but it is not known if this is necessary. It is also not known whether arthrographic distention using steroid and saline is better than intra-articular steroid injection alone.

The purpose of this study is to determine whether there is an additional benefit in the combination of arthrographic distention plus intra-articular corticosteroid injection compared to arthrographic distention or intra-articular corticosteroid injection alone.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: November 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pain and stiffness in predominantly 1 shoulder for 4 weeks or longer

• Restriction of passive motion of greater than 30° in 2 or more planes of movement (measured to onset of pain with goniometer)

Exclusion Criteria:

• Previous arthrographic distention and/or corticosteroid injection

• Systemic inflammatory joint disease

• Radiological evidence of osteoarthritis of the shoulder or fracture

• Signs of a complete rotator cuff tear

• Contraindications to arthrogram and/or distention

• Lack of written informed consent

Study Design

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Frozen Shoulder

Intervention

Procedure:
• Arthrographic distention
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.

Drug:
• Intra-articular corticosteroid Depo Medrol
Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden	Antwerpen

Sponsors (2)

Lead Sponsor	Collaborator
Imelda Hospital, Bonheiden	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Mar;63(3):302-9. — View Citation

Corbeil V, Dussault RG, Leduc BE, Fleury J. [Adhesive capsulitis of the shoulder: a comparative study of arthrography with intra-articular corticotherapy and with or without capsular distension]. Can Assoc Radiol J. 1992 Apr;43(2):127-30. French. — View Citation

Gam AN, Schydlowsky P, Rossel I, Remvig L, Jensen EM. Treatment of "frozen shoulder" with distension and glucorticoid compared with glucorticoid alone. A randomised controlled trial. Scand J Rheumatol. 1998;27(6):425-30. — View Citation

Jacobs LG, Barton MA, Wallace WA, Ferrousis J, Dunn NA, Bossingham DH. Intra-articular distension and steroids in the management of capsulitis of the shoulder. BMJ. 1991 Jun 22;302(6791):1498-501. — View Citation

Khan AA, Mowla A, Shakoor MA, Rahman MR. Arthrographic distension of the shoulder joint in the management of frozen shoulder. Mymensingh Med J. 2005 Jan;14(1):67-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain and disability index(SPADI)		4 weeks	No
Secondary	Shoulder pain and disability index (SPADI)		weekly for a period of 3 months plus at follow-up (4 months and 12 months)	No
Secondary	Overall pain score	Universal pain scale	weekly for a period of 3 months, plus at follow-up (4 months and 12 months)	No
Secondary	Range of motion	Total shoulder abduction (in degrees, measured with goniometer); External rotation in neutral position (in degrees, measured with goniometer); Hand behind back (highest reachable anatomical landmark)	4 weeks, 4 months and 12 months	No