Comparing Injection Treatments for Tennis Elbow

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.

For those allocated to receive a PRP injection (Group A), the whole blood will be placed in a cell separator and centrifuged at 32000 rpm for 15 minutes. Whilst the blood is being centrifuged, 2ml of 2% plain lidocaine will be injected into the subcutaneus layer at the site where the PRP is to be injected. 1ml of the PRP produced will then be drawn into a syringe which will be wrapped in silver foil so as to conceal the contents from the participants. The PRP will then be injected into the lateral epicondyle via a blue (20 gauge) hypodermic needle using a peppering technique under ultrasound control.

For Groups (B) and (C), the withdrawn blood will be discarded into a suitable clinical waste container out of sight of the participant in an adjoining room. The centrifuge, also in the adjoining room, will be set to run at 32000rpm for 15 minutes in order to aid in participant blinding. For those in group (B), whilst the centrifuge is running, 2ml of 2% plain lidocaine will be injected into the subcutaneous layer at the site of injection. A pre-prepared 'Ostenil Tendon' syringe will be wrapped in silver foil (again to help conceal the nature of the contents from the participants) and 2ml will be injected into the peri-tendinous area via a blue (20 gauge) hypodermic needle under ultrasound control.

For those in group (C) whilst the centrifuge is running, 2ml of 2% plain lidocaine will be injected into the subcutaneous layer at the site of injection. An empty syringe wrapped in silver foil with a blue (20 gauge) will then be used to perform a sham injection into the subcutaneous tissue only, by passing the needles into the tissue with no injectate.

In order to further aid blinding of participants, during the procedure they will be distracted by asking them to confirm their personal details.

In order to gain a measure of how the participant's pain changes in the days and weeks following surgery, they will be given a pain diary on the day of their treatment to complete on days 1,2,3,7,14, and at 6 and 12 weeks.

Prior to discharge from the hospital participants will be taught basic home exercises by a physiotherapist who is unaware of the participant's group allocation. they will then begin a specifically designed, formal, class-based physiotherapy program 5-15 days post-injection. Exercises taught on the day of treatment will include eccentric loading exercises of the wrist extensors and they will be asked to commence these exercises the day after the injection and to complete 3 sets of 15 repetitions 3 times per day. They will also be taught simple stretches of the wrist extensors to complete after each set of eccentric strengthening exercises.

The formal physiotherapy program will include fortnightly physiotherapy classes taught by a blinded physiotherapist. After being taught the exercises on a 1:1 basis in order to ensure correct technique, the participants will be supervised during a circuit style exercise program. The circuit will include exercises to load the common extensors, strengthening of the rotator cuff muscles, strengthening of the scapular stabilising muscles and upper limb strengthening using the full kinetic chain. Participants will also be taught a home exercise program which will reflect the content of the class circuit.

At 3 months and 12 months post-injection participants will be assessed by a clinician who again is unaware of the participant's grouping. At each follow-up, the participants will be asked to complete the patient reported outcome questionnaires. They will also be asked regarding their use of rescue medication (i.e. how much analgesic medication they require to manage their pain) and this will be recorded by the clinician.

If any participant is unable to attend the hospital for follow-up at either the 3 or 12 month time-point, they will be contacted by telephone to gather the outcome information. All participants will be discharged from the care of the treating consultant at 12 weeks unless enduring or subsequently manifesting symptoms are present and the final 12 month visit will therefore be solely for the purposes of research.

• The change from baseline in objective pain scores as evidenced by the Visual Analogue Pain Scale (VAS) at 12 months post-treatment. [Срок оценки: The VAS will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.]
• The change in objective functional assessment as evidenced by the Oxford Elbow Score (OES) [Срок оценки: The OES will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.]
• Change in general health-related quality of life as evidenced by change in the EQ-5D general health questionnaire. [Срок оценки: The EQ-5D will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.]
• Relationship of pre-injection Hospital Anxiety and Depression Scale (HADS) score to the outcome [Срок оценки: The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.]
• Change in HADS score at 12 months compared to baseline [Срок оценки: The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.]