Comparison of the efficacy of cortisone injection with cortisone injection plus hydrodilatation for treatment of stiff painful shoulders.
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
- •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)