Platelet Rich Plasma vs Open Surgery in the Treatment of Tennis Elbow

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 To randomise patients who have failed conservative management of tennis elbow to one of two treatment methods: Platelet Rich Plasma or Open Surgical Release To collect treatment outcome data in the form of a visual analogue scale, Oxford Elbow Score and DASH (Disability of Arm, Shoulder and Hand) score To use the current best guidance and administer leucocyte-rich PRP (L-PRP) under ultrasound guidance To use the data gained from a pilot study to assess the viability of a larger randomised control trial Research design This pilot study will be conducted as a randomised controlled pilot trial at the Royal Devon and Exeter Hospital, UK. Patient Selection Patients will be selected from those who attend the outpatient elbow clinic at the Royal Devon and Exeter Hospital. All patients will be reviewed by a Consultant Orthopaedic Surgeon specialised in Elbow surgery. The inclusion criteria will be any patient who has experienced more than 6 months of symptoms from tennis elbow, that include 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) and have a baseline elbow pain >3/10 on VAS during resisted elbow extension. Patients will be excluded: in the presence of a full tendon tear on pre-intervention ultrasound, are 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 or are unable to comply with follow-up. Intervention The 2 arms of the trial will include PRP therapy or Open surgical debridement Platelet Rich Plasma injection Open Surgical Release (presently standard treatment regimen) Both groups of patients will be given an identical physiotherapy programme and followed-up at identical timeframes to record the outcomes of the interventions. Sample size The present proposal is intended to be a pilot study. As such the intention will be to randomise 6 patients to each arm of the trial, 12 patients in total. It has been estimated that 1 suitable patient is likely to be seen in the outpatient clinic each week. Owing for attrition and patient suitability it is hoped that a 6 month enrolment period will yield 12 patients. Randomisation The participating patients will be randomised in a 1:1 allocation to open surgery or PRP injections. The randomisation will be administered by a central independent randomisation service, provided by a medical secretary using a computer-generated randomisation sequence and sealed in sequentially numbered envelopes, who is completely independent of the trial. Outcome scoring Primary outcome measures will be in the form of Patient Reported Outcome Measures (PROMS) and Range of Motion (ROM) Primary Outcome: Change in Patient Rated Tennis Elbow Evaluation (PRTEE) between pre-intervention and at 3 months post-intervention - patient compiled questionnaire based on specific elbow symptoms of Tennis Elbow All secondary outcome measures to be completed pre-operatively and at 6 weeks, 3 months, 6 months and 12 months. ● PROMS Visual Analogue Scale (VAS) - Using a linear scale of 10cms length. Assessed through change in score over time. Disabilities of the Arm, Shoulder and Hand (quickDASH) - patient compiled questionnaire based on subjective assessment of symptoms and abilities to perform activities of daily living over the last week. Oxford Elbow Score (OES) - patient compiled questionnaire based on specific elbow symptoms related activities of daily living over the past 4 weeks. Adverse events - peri-procedural, 6 weeks, 3 months, 6 months and 12 months

Official Title
-----------------
Platelet Rich Plasma vs Open Surgery in the Treatment of Chronic Lateral Epicondylar Tendinopathy (Tennis Elbow) A Pilot Randomized Control Trial

Conditions
-----------------
Tennis Elbow

Intervention / Treatment
-----------------
* Procedure: Platelet Rich Plasma Injection
* Procedure: Open Surgical Release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma injection<br>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. | Procedure: Platelet Rich Plasma Injection<br>* See Arms<br>|
| Active Comparator: Open Surgical Release<br>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. | Procedure: Open Surgical Release<br>* See arms<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Rated Tennis Elbow Evaluation (PRTEE) | patient compiled questionnaire based on specific elbow symptoms of Tennis Elbow | To be completed pre-intervention and at 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Scale (VAS) | - Using a linear scale of 10cms length. Assessed through change in score over time. | To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention | 
| Change in Disabilities of the Arm, Shoulder and Hand (quickDASH) | - patient compiled questionnaire based on subjective assessment of symptoms and abilities to perform activities of daily living over the last week. | To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention | 
| Change in Oxford Elbow Score (OES) | - patient compiled questionnaire based on specific elbow symptoms related activities of daily living over the past 4 weeks. | To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention | 
| Adverse events | Safety assessment | peri-procedural, 6 weeks, 3 months, 6 months and 12 months |