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

NCT ID: NCT01983527

Last Updated: 2013-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-11-30

Brief 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.

Conditions

Adhesive Capsulitis; Frozen Shoulder

Keywords

Arthrographic distention; Hydrodilatation; Intra-articular corticosteroid injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arthrographic distention + intra-articular corticosteroid

Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension), 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.

Group Type: EXPERIMENTAL

Arthrographic distention

Intervention Type: PROCEDURE

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

Intra-articular corticosteroid Depo Medrol

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Arthrographic distention

Intervention Type: PROCEDURE

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

Intra-articular corticosteroid

Arthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension).

Group Type: ACTIVE_COMPARATOR

Intra-articular corticosteroid Depo Medrol

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

Intra-articular corticosteroid Depo Medrol

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

Intervention Type: DRUG

Other Intervention Names

Hydrodilatation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Imelda Hospital, Bonheiden

OTHER

Sponsor Role: lead

Responsible Party

Symons Rolf

Symons Rolf, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolf Symons, MD

Role: PRINCIPAL_INVESTIGATOR

Imeldaziekenhuis

Locations

Imelda Hospital

Bonheiden, Antwerpen, Belgium

Countries

Belgium

Central Contacts

Rolf Symons, MD

Role: CONTACT

Phone: +32(0)15/50.62.31

Email: rolf.symons@imelda.be

Facility Contacts

Rolf Symons, MD

Role: primary

References

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. doi: 10.1136/bmj.302.6791.1498.

Reference Type: BACKGROUND

PMID: 1855018 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1562888 (View on PubMed)

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. doi: 10.1080/030097498442244.

Reference Type: BACKGROUND

PMID: 9855212 (View on PubMed)

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. doi: 10.1136/ard.2002.004655.

Reference Type: BACKGROUND

PMID: 14962967 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15695959 (View on PubMed)

Other Identifiers

CADAC

Identifier Type: -

Identifier Source: org_study_id