None listed
Conditions
Brief summary
A comparison of two currently used treatments for a stiff painful shoulder (adhesive capsulitis, frozen shoulder). Under x-ray control a radiologist (X-Ray doctor) injects cortisone and local anaesthetic into the patient's shoulder joint. There are two groups of patients. One group then receives an additional injection of normal saline (up to around 50 mls of sterile salty water) to try to stretch the shoulder ligaments (capsule) . The patients are then assessed clinically and by questionnaire at 8 and 12 weeks post procedure to assess increased shoulder movement. Both techniques are curently used. if one is demonstrably better than the other then it may change clinical practice.
Interventions
The cortisone injection plus an additional hydrodilatation is the intervention treatment. A radiologically assisted intra-articular (gleno-humeral joint) injection of 4mls of local anaesthetic (marcaine), 4 mls of celestone chondrose (betamethasone 5.7mgs per 2 mls) and normal saline to expand the joint capsule to capsular rupture, is administered once only. Following the injection the patients will be clinically assessed at 8 weeks and 12 weeks post procedure.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria Pain and stiffness of the shoulder ranging from 3 weeks to 9months. Restriction of passive range of movement of the glenohumeral joint by more than 30 degrees in 2 or more planes of motion. Age 18-90
Exclusion criteria
Exclusion criteria Age<18yo ; age>90yo Osteoarthritis of the glenohumeral joint as demonstrated on plain Xray. Calcific tendonitis of the shoulder as demonstrated on plain Xray. Avascular necrosis of any bone on the ipsilateral shoulder as demonstrated on plain Xray or MRI. Systemic inflammatory disorder – e.g. rheumatoid arthritis, systemic lupus erythematosus. Previous ipsilateral shoulder surgery involving a replacement or repair which include rotator cuff repair or stabilisations. Previous internal fixation of the ipsilateral proximal humerus. Full thickness rotator cuff tear defined radiologically on ultrasound or MRI. Rotator cuff tear demonstrated radiologically during the trial contrast injection. Soft tissue or bony tumors around or involving the ipsilateral shoulder as demonstrated on plain Xray or MRI. Previous intra-articular corticosteroid injection or hydrodilatation injection within 12 months Pregnant Cervical radiculopathy Contraindications to the procedure: contrast allergy Major trauma within 6 months of presentation involving:- any bony fracture(demonstrated on plain Xray) of the upper limb requiring immobilisation of the glenohumeral joint any bony fracture(demonstrated on plain Xray) or ligamentous injury of the pectoral girdle up to and including the sternoclavicular joint requiring immobilisation of the glenohumeral joint Manipulation under general anaesthetic Complex regional pain syndrome Mental illness Intellectual Disability Unable to converse or read in English Refused to participate in the trial (Subacromial injection is not an exclusion)
Outcome results
None listed