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

Imelda Hospital, Bonheiden

Status: Unknown

Conditions: Frozen Shoulder; Adhesive Capsulitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01983527

CADAC

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 3 patient groups

Arthrographic distention + intra-articular corticosteroid

Experimental group

Description:

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.

Treatment:

Procedure: Arthrographic distention

Drug: Intra-articular corticosteroid Depo Medrol

Arthrographic distention

Active Comparator group

Description:

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

Treatment:

Procedure: Arthrographic distention

Intra-articular corticosteroid

Active Comparator group

Description:

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

Treatment:

Drug: Intra-articular corticosteroid Depo Medrol