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.