Platelet Rich Plasma vs Open Surgery in the Treatment of Chronic Lateral Epicondylar Tendinopathy (Tennis Elbow) A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
研究概览
简要总结
Chronic Lateral Epicondylar Tendinopathy is a debilitating condition that is associated with repetitive use of the forearm extensor muscles. Though often self-limiting in nature there are a proportion of patients who fail to respond to conservative treatments such as rest, activity modification, physiotherapy and the use of a brace. Though previously a common treatment modality steroid injections have been shown to be detrimental in the longer term. Present practice is to offer those patients who do not respond to conservative treatment surgical debridement. Though often effective this is an invasive procedure. Platelet rich plasma injections may offer a viable alternative in chronic cases however there is no systematic evidence of its efficacy.
Methods 12 patients, diagnosed with chronic lateral epicondylar tendinopathy, will be randomly assigned to receive either open surgical debridement or platelet rich plasma injections. Following treatment, they will be followed up at intervals of 6 weeks and 3, 6 and 12 months. The outcome of each treatment will be assessed using validated outcome scoring measures specifically designed for upper limb pathology. The results of this pilot study will be used to construct a larger randomised control trial.
详细描述
Research Question
There is no difference in patient reported outcome measures between open surgical release and platelet rich plasma injection in the treatment of chronic lateral epicondylar tendinopathy (Tennis Elbow).
Aims
- To estimate the distribution of patient-reported outcome measures (PROMS) at 6 weeks, 3 months, 6 months and 1 year
- To record any adverse events associated with either treatment
- To test the feasibility of the study design in preparation for a larger randomised trial
- To collect data that will allow a power calculation for a larger randomised trial
- To use the data for a larger grant application
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient who:
- •Has experienced more than 6 months of symptoms from tennis elbow (pain on the lateral elbow that radiates down the forearm, point tenderness over the origin of the extensor muscles or at its close proximity (within 2.5cm) and pain on resisted extension of the Wrist).
- •Patients must also have failed conservative treatment (a course of physiotherapy and activity modification)
- •Baseline elbow pain >3/10 on VAS during resisted elbow extension.
排除标准
- •Presence of a full tendon tear on pre-intervention ultrasound
- •Unfit for surgical intervention
- •Have undergone previous elbow surgery,
- •Have previously undergone PRP injection therapy
- •Systemic autoimmune rheumatological disease
- •Receiving immunosuppressive treatments
- •Received local steroid injection within 3 months of randomization
- •Unable to comply with follow-up.
研究组 & 干预措施
Platelet Rich Plasma injection
In the outpatient setting a sample of venous whole blood will be taken from the patient (40mls), from the antecubital fossa using standard phlebotomy techniques. The Angel™ system will be in the available also in the outpatient clinic and will be used to separate the blood to yield a PRP sample (approximately 15 minutes preparation time). The PRP sample is then injected into the common extensor origin.
2 injections will be used per patient over 2 weeks.
干预措施: Platelet Rich Plasma Injection (Procedure)
Open Surgical Release
Standardised surgical technique based on the Nirschl technique will be used. The patient will then have a small scar centred over the lateral epicondyle and the plane opened between ECRL (Extensor Carpi Radialis Longus) and EDC (Extensor Digitorum Communis) to expose the damaged ECRB (Extensor Carpi Radialis Brevis) tendon. The amount of abnormal tendon will be documented and excised. EDC will also be inspected and any abnormal tissue documented then excised. The footprint of the excised ECRB +/- EDC is cleared of soft tissue and the bone scored with an osteotome to promote bleeding. The interval is closed with suture material and the skin wound closed.
干预措施: Open Surgical Release (Procedure)
结局指标
主要结局
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
时间窗: To be completed pre-intervention and at 3 months post-intervention
patient compiled questionnaire based on specific elbow symptoms of Tennis Elbow
次要结局
- Change in Disabilities of the Arm, Shoulder and Hand (quickDASH)(To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention)
- Change in Oxford Elbow Score (OES)(To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention)
- Change in Visual Analogue Scale (VAS)(To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention)
- Adverse events(peri-procedural, 6 weeks, 3 months, 6 months and 12 months)