Adhesive Capsulitis
Conditions
Brief summary
The purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder.
Interventions
PROCEDUREisotonic saline injection into the glenohumeral joint
* Total volume of injection drugs: 8ml * isotonic saline 4ml + telebrix(contrast media) 4ml * The number of injections : only once during the study period * Injection site : glenohumeral joint * Material : 22-gauze spinal needle * Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.
* Total volume of injection drugs: 8ml * triamcinolone(40mg)1ml + isotonic saline 3ml + telebrix(contrast media)4ml * The number of injections : only once during the study period * Injection Site : glenohumeral joint * Material : 22-gauze spinal needle * Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.
PROCEDUREsodium hyaluronate injection into the glenohumeral joint
* Total volume of injection drugs: 8ml * sodium hyaluronate 2ml + isotonic saline 2ml + telebrix(contrast media)4ml * The number of injections : only once during the study period * Injection Site : glenohumeral joint * Material : 22-gauze spinal needle * Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.
PROCEDUREsteroid and hyaluronate injection into the glenohumeral joint
* Total volume of injection drugs: 8ml * triamcinolone(40mg)1ml + sodium hyaluronate 2ml + isotonic saline 1ml + telebrix(contrast media)4ml * The number of injections : only once during the study period * Injection Site : glenohumeral joint * Material : 22-gauze spinal needle * Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis : Adhesive Capsulitis of the Shoulder * defining of adhesive capsulitis * the presence of shoulder pain * limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions(abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder * duration : symptomatic for \< 1 year
Exclusion criteria
* bilateral symptoms * uncontrolled diabetes mellitus * overt hypothyroidism or hyperthyroidism * previous shoulder surgery * previous glenohumeral joint injection within recent 6months * trauma to the shoulder the last six months that required hospital care * neurological symptoms * allergy to injection material * secondary adhesive capsulitis * systemic inflammatory ds including rheumatoid arthritis * degenerative arthritis of shoulder joint * infectious arthritis of shoulder joint * dislocation of shoulder joint * blood coagulation disease * rotator cuff tear * serious mental illness * pregnancy * fracture in shoulder lesion * CVA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPADI Score (Shoulder Pain and Disability Index) | Postinjection 1month |
Countries
South Korea
Outcome results
None listed