Comparing Injection Treatments for Tennis Elbow
brief summary
Tennis elbow is one of the most common musculoskeletal problems affecting the arm and is thought to be mainly due to overuse of the muscles that extend the wrist. The pain arises from the lateral epicondyle of the humerus, where the tendons of the wrist extensor muscles attach. There are many treatment options available for tennis elbow including oral medication, physiotherapy and injection therapy. Surgical options are reserved for those who fail to respond to more conservative treatments. Physiotherapy is a widely used, non-invasive treatment option for the management of tennis elbow. Research has shown that in the longer term, physiotherapy is superior to corticosteroid injection in the treatment of tennis elbow and a meta-analysis of published research concluded that Platelet Rich Plasma injection and Hyaluronic Acid injection are superior to corticosteroid for long term pain relief in tennis elbow. At present there is not enough evidence to indicate what the 'Gold Standard' treatment for tennis elbow is, and more research is therefore needed to help guide decision-making. The aim of this study is therefore to examine the effects of injection therapy in addition to physiotherapy treatment, in comparison to physiotherapy and a control injection on pain and function in patients with tennis elbow. All participants in this study will undergo a structured, specifically designed, class-based physiotherapy intervention, in addition to being randomly allocated to receive one of the following three types of injection: (a) a control injection whereby a needle is inserted into the skin but no therapeutic substance is injection, (b) a single therapeutic injection of platelet-rich plasm or (c) a single therapeutic injection of hyaluronic acid. Baseline data will be collected at the time of recruitment and participants will be followed up at 3 months and 12 months post treatment. Outcomes will be assessed using various patient-reported outcome measures in addition to clinical examination. The primary outcome for this study is the improvement in the quick DASH score at 12 months post-treatment compared to baseline.
detailed description
The design of the current study is a prospective, randomised, controlled, double blinded, single centre trial.
On the day of their initial appointment in the outpatient department, patients diagnosed with tennis elbow by their consultant who meet all of the necessary inclusion and exclusion criteria will be introduced to the study by the consultant. They will also be provided with a copy of the participant information sheet.
When the potential participant then attends their pre-operative assessment appointment, they will be invited to discuss the study further with a member of the host Trust's research team. If they then wish to proceed, they will be invited to read and sign a copy of the study consent form. Consenting patients will then be asked to complete a questionnaire designed to record all relevant demographic data including: Age, gender, affected side, dominant side, weight, height (so that BMI may be calculated), duration of symptoms, current use of pain-relieving medications, occupation, leisure activities and ethnicity. They will also be asked to complete a visual analogue pain scale, and the following 4 validated patient reported outcome measures.
Following completion of the patient reported outcome questionnaires, participants will then be randomised to one of the following three treatment groups: Group(A)will receive a standardised, class-based physiotherapy program in addition to a single therapeutic injection of Platelet-Rich Plasma; Group (B) will undergo an identical physiotherapy program to group A, but with a single therapeutic injection of sodium hyaluronate with mannitol; or group (C) who will undergo an identical physiotherapy program to both groups (A) and (B), however they will receive a sham injection, which will penetrate the skin, but no therapeutic substance will be injected.
The randomisation sequence will be generated using freely available online randomisation facilities prior to the start of the study. Participants will be randomised to either Group A, Group B or Group C in a 1:1:1 ratio (see above for group descriptions). The allocation sequence will be concealed in sealed opaque envelopes which will be prepared prior to the start of the study and will be opened after informed consent has been gained and baseline data has been collected.
Consenting participants will all attend Wrightington Hospital for their allocated injection to be administered under ultrasound guidance to ensure accurate needle placement. All participants will have 30mls of whole blood drawn under aseptic conditions in order to aid blinding of participants to their treatment allocation.
official title
A Prospective, Double Blind, Single Centre, RCT, Comparing the Effectiveness of Physiotherapy in Addition to One of 3 Types of Image Guided Injection of the Common Extensor Tendon, on Pain and Function in Patients With Tennis Elbow.