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

NCT01983527 | Unknown DMC

• 1 other identifier: CADAC
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Shoulder pain and disability index(SPADI)

  4 weeks

Secondary Outcomes (3)

• Shoulder pain and disability index (SPADI)

  weekly for a period of 3 months plus at follow-up (4 months and 12 months)

• Overall pain score

  weekly for a period of 3 months, plus at follow-up (4 months and 12 months)

• Range of motion

  4 weeks, 4 months and 12 months

Study Arms (3)

Arthrographic distention + intra-articular corticosteroid

EXPERIMENTAL

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.

Procedure: Arthrographic distention; Drug: Intra-articular corticosteroid Depo Medrol

Arthrographic distention

ACTIVE COMPARATOR

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

Procedure: Arthrographic distention

Intra-articular corticosteroid

ACTIVE COMPARATOR

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

Drug: Intra-articular corticosteroid Depo Medrol

Interventions

Arthrographic distention PROCEDURE

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

Also known as: Hydrodilatation

Arthrographic distention; Arthrographic distention + intra-articular corticosteroid

Intra-articular corticosteroid Depo Medrol DRUG

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

Arthrographic distention + intra-articular corticosteroid; Intra-articular corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imelda Hospital, Bonheiden: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

Imelda Hospital

Bonheiden, Antwerpen, 2820, Belgium

Location

Related Publications (5)

• 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.

  PMID: 1855018 BACKGROUND

• 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.

  PMID: 1562888 BACKGROUND

• 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.

  PMID: 9855212 BACKGROUND

• 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.

  PMID: 14962967 BACKGROUND

• 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.

  PMID: 15695959 BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Rolf Symons, MD

  Imeldaziekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rolf Symons, MD

CONTACT

+32(0)15/50.62.31; rolf.symons@imelda.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Symons Rolf, MD

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: November 1, 2015
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

BE (1)