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
Overview
- Phase
- Not Applicable
- Intervention
- Arthrographic distention
- Conditions
- Adhesive Capsulitis
- Sponsor
- Imelda Hospital, Bonheiden
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Shoulder pain and disability index(SPADI)
- Last Updated
- 12 years ago
Overview
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.
Investigators
Symons Rolf
Symons Rolf, MD
Imelda Hospital, Bonheiden
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
Arms & Interventions
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.
Intervention: Arthrographic distention
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.
Intervention: Intra-articular corticosteroid Depo Medrol
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: Arthrographic distention
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).
Intervention: Intra-articular corticosteroid Depo Medrol
Outcomes
Primary Outcomes
Shoulder pain and disability index(SPADI)
Time Frame: 4 weeks
Secondary Outcomes
- 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)
- Overall pain score(weekly for a period of 3 months, plus at follow-up (4 months and 12 months))