Adhesive Capsulitis
Conditions
Keywords
shoulder
Brief summary
Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to affect 25% of the general population. Many forms of treatment have been advocated for frozen shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid, manipulation under anesthetic and arthroscopic releases. There is no general agreement in favour of one form of treatment, and the response to a particular treatment varies in different series. A few randomized controlled trials appear in the literature. Most of these showed improvements with steroid use, but the results were not always statistically significant. One randomized control trial reported superior results in favor of arthrographic joint distension with steroid compared to a saline placebo. To our knowledge there have been no other similar randomized trials to support these results. The objective of this study is to determine if arthrographic distension of the shoulder joint with steriods is an effective treatment modality for adhesive capsulitis as compared to injection with local anesthetic and contrast alone. The study design is a placebo-controlled, double blind clinical trial where participants will undergo distension arthrogram of the shoulder and be randomized to receive either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and contrast alone.
Interventions
OTHERLidocaine
receive once
DRUGTriamcinalone (steroid) and lidocaine
receive once
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age range 19-70 * Female and male * Ability to understand and give consent * Diagnosis of adhesive capsulitis (frozen shoulder) pain and stiffness for at least 3 months.
Exclusion criteria
* • Frozen shoulder secondary to trauma * Previous surgery on the affected shoulder * Age less than 19 or greater than 70 * Systemic inflammatory joint disease such as Rheumatoid Arthritis * Radiographic evidence of osteoarthritis of the shoulder * Allergy to contrast material * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| functional outcomes as determined by the SPADI | change in baseline at 1 year. |
Secondary
| Measure | Time frame |
|---|---|
| passive range of motion | baseline, 3 and 6 and 12 week post injection. |
Countries
Canada
Outcome results
None listed