Comparison of effects of intra-articular platelet rich plasma and corticosteroid injection in Adhesive capsulitis of shoulder joint: a double blinded randomized control study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Reduction of disability and improvement of Range of motion.
研究概览
简要总结
Patients between 18-70 years of either sex who comes to orthopaedic OPD, clinically diagnosed with adhesive capsulitis during my study period, who are fulfilling the inclusion criteria will be explained about study purpose, procedures, potential risks, and benefits. Informed consent will be taken. The first patient will be allotted in group A(methylprednisolone acetate) and the next patient will be allotted to group B (PRP). Same pattern will be continued for the study. This way randomization is done. Relevant
blood investigations, x-ray / ultrasonography evaluation of the shoulder will be done to rule out other causes. Both patients and trained personal who is giving the injection will be unaware of the group in which the patient is allotted. Identical syringes (covered) are used to maintain blinding.
Intra-articular injections of methylprednisolone acetate (40mg) or platelet rich plasma will given to the respective groups according to the randomization. Injection will be administered by a trained personal under ultrasound guidance. Patients are seated on a chair, in an upright position with their hands positioned on their thigh. A 23- gauge, 7cmlong needle will be inserted parallel to the ultrasound
probe until tip of the needle is inside the gleno-humeral joint. Preparation of PRP: - Draw 20 ml of venous blood and collect it in the PRP tube Centrifuge the PRP tube at 4400 RPM for 12 minutes followed by 2200 RPM for 10 minutes. Aspirate the Platelet rich plasma, from the Buffy coat layer.
All injections ,IA-PRP (2 ml) and IA- Methylprednisolone acetate 2ml ( 1ml of methyl prednisolone acetate + 1ml of 2% of lignocaine) to be given under aseptic condition. After giving injection, patients will be given Paracetamol + Tramadol for the initial pain relief. Patients will be advised for physiotherapy and follow up at 2 weeks, 6 weeks, 3 months and 6 months in orthopaedic OPD. Schedule regular follow-up assessments to monitor participants progress, including range of motion, pain levels by visual analogue scale (VAS) score, Shoulder Pain And Disability Index (SPADI) Collect quantitative data on outcomes, ensuring standardized measurement score are used consistently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed as primary AC, with duration of symptoms less than 6 months,
- •Normal radiograph of the affected shoulder,
- •Moderate to severe VAS Score and limitation of both Active and passive movements of gleno-humeral joint in 2 or more directions (abduction, adduction, flexion, extension, external rotation, internal rotation).
- •4.If bilateral involvement and qualify for inclusion, only dominant arm is considered for intervention.
排除标准
- •1.secondary adhesive capsulitis, secondary to inflammatory joint disease, structural ,functional limitations in the shoulder joint from any other pre-existing musculoskeletal pathology or neurological disorder 2.Uncontrolled Diabetes Mellitus 3.Underwent any intra-articular injection/ invasive procedure/surgery in the shoulder joints.
- •4.Who are unable to follow exercise program.
- •5.Any local skin pathology at injection site.
结局指标
主要结局
Reduction of disability and improvement of Range of motion.
时间窗: 6 months
次要结局
- Compare the outcome of intra-articular PRP vs CS injection in the treatment of adhesive capsulitis.(6 months)
研究者
Dr Sreeju R S
SDM college of medical sciences and Hospital Dharwad– 580009.