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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adhesive Capsulitis, Frozen Shoulder

Intervention / Treatment
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* Procedure: Arthrographic distention
* Drug: Intra-articular corticosteroid Depo Medrol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthrographic distention + intra-articular corticosteroid<br>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<br>* Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.<br>* Other names: Hydrodilatation;Drug: Intra-articular corticosteroid Depo Medrol<br>* Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)<br>|
| Active Comparator: Arthrographic distention<br>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<br>* Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.<br>* Other names: Hydrodilatation;|
| Active Comparator: Intra-articular corticosteroid<br>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<br>* Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain and disability index(SPADI) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Universal pain scale | weekly for a period of 3 months, plus at follow-up (4 months and 12 months) | 
| Range of motion | 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) | 4 weeks, 4 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthrographic distention, Hydrodilatation, Intra-articular corticosteroid injection