Adhesive Capsulitis, Frozen Shoulder
Conditions
Keywords
Arthrographic distention, Hydrodilatation, Intra-articular corticosteroid injection
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.
Interventions
PROCEDUREArthrographic distention
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
DRUGIntra-articular corticosteroid Depo Medrol
Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)
Sponsors
Universitaire Ziekenhuizen KU Leuven
Imelda Hospital, Bonheiden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder pain and disability index(SPADI) | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Universal pain scale |
| 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) |
Countries
Belgium
Contacts
Primary ContactRolf Symons, MD
Outcome results
None listed