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

Not Applicable

• Conditions: Frozen Shoulder; Adhesive Capsulitis
• Interventions: Procedure: Arthrographic distention; Drug: Intra-articular corticosteroid Depo Medrol

• Registration Number: NCT01983527
• Lead Sponsor: Imelda Hospital, Bonheiden

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-13
• Last Update Submitted: 2013-11-13
• Study First Posted: 2013-11-14
• Last Update Posted: 2013-11-14
• Study Start: 2013-12
• Primary Completion: 2014-12
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthrographic distention + intra-articular corticosteroid	Arthrographic distention	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.
Arthrographic distention + intra-articular corticosteroid	Intra-articular corticosteroid Depo Medrol	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.
Arthrographic distention	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.
Intra-articular corticosteroid	Intra-articular corticosteroid Depo Medrol	Arthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension).

Primary Outcome Measures

Name	Time	Method
Shoulder pain and disability index(SPADI)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Shoulder pain and disability index (SPADI)	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	* 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)
Overall pain score	weekly for a period of 3 months, plus at follow-up (4 months and 12 months)	Universal pain scale

Trial Locations

Locations (1)

Imelda Hospital; 🇧🇪 Bonheiden, Antwerpen, Belgium