The comparison of the efficacy of cortisone injection compared with cortisone injection plus hydrodilatation for treatment of a stiff painful shoulder

Not Applicable

Active, not recruiting

• Conditions: Stiff painful shoulder; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12611000748910
• Lead Sponsor: Monash University

Brief Summary

Preliminary Results: Eighty-two patients were enrolled, 40male and 42 female aged 29-70 (av.54). Hand dominance was 75 right and 7 left. The dominant shoulder was affected in 49% of cases. The ROM motion improved by at least 30 degrees in 2 or more planes between baseline and 8 weeks in 40% in group 1(cortisone alone) and 36% in group 2 (cortisone plus Hydrodilatation) (p=0.689) and by 52% and 61% between baseline and 12 weeks in group 1 (cortisone) and group 2 (Hydro) respectively (p=0.485), indicating no statistically significant differences between the treatment groups at either follow up interval. Overall, regardless of treatment allocation, 26.83 % of patients showed no improvement in any plane at 8 weeks. In Group 1(cortisone) 25% of patients did not improve in any of the four planes, and Group 2 (Hydro) 28.6% did not improve in any plane (p = 0.715). In Group 1 (cortisone) there was improvement in all measured planes in 12.5% and in group 2 (hydro) 4.8% (p =0.259).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-18
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increased global painfree movement of the shoulder . Assessed by clinical examination and PROMS (patient reported outcome measures) the Constant score, SST,(simple shoulder test), ASES (American shoulder and elbow surgeons ) and SPADI (shoulder pain and disability index) 80 patients will be enrolled to give an 80% power to detect a clinical difference between the groups[ 8 and 12 weeks from intervention.]

Secondary Outcome Measures

Name	Time	Method
nil[ nil]