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.
Phase: NA
Conditions: Tennis Elbow, Lateral Epicondylitis, Elbows Tendonitis
Sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust

1 
PROTOCOL 
Full Study Title : A Prospective, Controlled, Randomised, Double Blind, 
Single Centre Study, Comparing the Effectiveness of Physiotherapy and Image 
Guided Injection of the Lateral Epicondyle of the Common Extensor Tendon with 
either Sodium Hyaluronate with Mannitol (Ostenil TendonTM),  Platelet Rich Plasma 
(PRP), or Sham Injection on Pain and Function in Patients with Lateral Epicondyle 
Tendinosis.  
 
Modified title compliant with character restrictions on clinicaltrials.gov register: 
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. 
 
Version 10 
23rd May 2018 
 
Brief Title: Comparing Injection Treatments for Tennis Elbow (CITTE) Trial. 
 
IRAS number 223134 
 
Investigators:  Professor Adam Watts 
                                    
Study venue: Wrightington Hospital 
 
 
 
 
 

2 
Aim : To determine the effect of a structure physiotherapy programme and a single image guided 
peri-tendinous injection to the lateral epicondyle, of either; Sodium Hyaluronate with mannitol 
(Ostenil Tendon™), Platelet Rich Plasma (PRP), or sham Injection on pain and function in 
patients with established elbow tendinopathy. 
 
Background. 
 
Tendinopathy of the common extensor tendon is one of the most prevalent musculoskeletal 
disorders of the arm, typically attributed to excessive use of the extensor and/or flexor muscles 
of the wrist, it is an overloading-induced injury resulting in pain and functional disability, often 
leading to limitation or cessation of activity and absence from work. Historically this syndrome 
has been referred to as lateral epicondylitis, which presents somewhat of a misnomer as 
histological evaluation typically displays no evidence of either acute or chronic 
inflammation.[1,2] Rather, repetitive muscle contraction leads to a neurocellular response 
provoking degradation by enzymes leading to angiofibroblastic degeneration and collagen 
disarray. Thus the current nomenclature includes ‘lateral epicondyle tendinopathy’, ‘lateral 
epicondyle tendinosis’, ‘lateral epicondylalgia’ or, more colloquially, ‘tennis elbow’.[2] 
 
Prevalence amongst the general population is reported to be between 1 and 3 percent, with an 
incidence rate of general practice consultations estimated to be between 0.3 to 1.1 per 100 
population per year.[1,3,5] Peak prevalence has been documented to be highest amongst subjects 
aged 45–54 years.[5] No distinct correlation has been identified between gender and incidence, 
however the condition appears to be more persistent and of greater symptomatic severity in 
females.[6] Smoking and obesity have been identified as associated risk factors.[5] Typical 
episodic duration lasts, on average, 6 to 24 months.[7] The dominant arm is affected in 75% of 
cases, reinforcing the view of the condition as an overuse syndrome.[8] Despite the sporting 
connotation, tennis players represent only 5% of all lateral epicondyle tendinopathy cases seen 
in clinical practice; yet between 40 to 50% of racket sport players will be diagnosed with the 
condition in their lifetime.[9,10] Most presentations are idiopathic in nature, not necessarily 
induced by sport, but associated with physical load factors: repetitive, manually intensive, high 
force demands.[4]  
 
ANATOMY AND DIAGNOSIS. 
 
The lateral epicondyle of the humerus provides attachment to the origin of the extensor carpi 
radialis brevis (ECRB), the extensor carpi radialis longus (ECRL), the extensor digitorum and the 
extensor carpi ulnaris - the primary motion of this muscle group is to extend the hand at the 
wrist. The primary locus of pathology in tendinopathy of the ECRB tendon is at the origin on the 
lateral epicondyle. Tendons are considered to be predisposed to degeneration at their insertion 
points, due to their relative hypovascularity in this region[3] 
 
Diagnosis of lateral epicondyle tendinopathy, which has a well-defined clinical presentation, is 
based on patient symptoms, a thorough consideration of the patient’s history, and physical 
evaluation. Imaging modalities are not required for diagnosis, although these can serve to more 

3 
fully determine the extent of tissue damage and identify differential diagnoses. Onset of lateral 
epicondyle tendinopathy commonly occurs with an absence of traumatic injury but rather as a 
gradual onset of symptoms.[4] Upon clinical examination, the area of maximum tenderness is 
usually defined distal to the origin of the extensor muscles of the forearm at the lateral 
epicondyle. Pain is exacerbated by active and resisted movement of the forearm. Range of 
motion may be affected in severe cases especially first thing in the morning and swelling may 
be observed in individuals with less subcutaneous fat. 
Treatment Options 
 
There are various treatment options available for lateral epicondyle tendinopathy. At present, 
however, there is a lack of objective evidence to support a universal consensus as to which 
constitutes the most effective or “Gold Standard” therapeutic intervention. Whilst no formal 
guidelines exist, a conservative approach has been advocated for initial management, with over 
90% of lateral epicondyle tendinopathy cases successfully resolving within 2 years of non-
surgical treatment, although surgery remains the ultimate option for those who fail to respond 
sufficiently to non-operative measures.[2,11] 
 
Over 80% of patients with lateral epicondyle tendinopathy report improvement within 1 year, 
which supports the often adopted wait-and-see policy.[7] Within this period, workload and 
activity modification is recommended to remove any exacerbating stimulus, relieve strain and 
allow time for healing.[12] Topical non-steroidal anti-inflammatory drugs (NSAIDs) may provide 
beneficial relief from pain compared with placebo in the short term (3-4 weeks)[13-16]. Oral 
NSAIDs have not been found to provide longer-term effects (> 4 weeks), however the risk of 
gastro-intestinal adverse effects is significantly increased.[13-17] The Cochrane review of NSAIDs 
for treating lateral elbow pain concludes that evidence on which to base recommendations for 
the longer-term use of NSAIDs is insufficient.[14] Local corticosteroid injections have been found  
to provide beneficial short-term therapeutic effect (< 6 weeks), however this was not continued 
into the intermediate (6 weeks to 6 months) or longer (> 6 months) terms.[15,18-19] Biset et al. 
found corticosteroid injection to be superior compared with physiotherapy at 6 weeks, 
however high reoccurrence rates were observed (47 of 65 patients deemed initial successes 
subsequently represented), and long term outcomes were found to be significantly poorer 
compared with physiotherapy.[20] Adverse effects include: post-injection pain, skin 
depigmentation, subcutaneous fat atrophy, and, in some instances, tendon and ligament 
rupture.[21,22] 
 
 
HYALURONIC ACID  
Hyaluronic acid (HA) is a naturally occurring polymer, ubiquitous to the human body. HA, in its 
aggregated form, is an important structural component of the articular cartilage matrix, 
imbibing water molecules to provide cartilage resilience to compressive forces. Unaggregated,  
HA is the main macro-molecular constituent of synovial fluid and is fundamental to its 
characteristic viscoelastic properties. This enables the intra-articular fluid to function as a 
lubricant and a shock absorber between congruent cartilaginous surfaces. HA does not only 

4 
exert a positive mechanical effect but serves a biological role, regulating matrix turnover and 
joint homeostasis, promoting the release of prostaglandins and interacting with various 
inflammatory mediators, inhibiting phagocytic activity of macrophage and leukocytes, and thus 
conferring a chondroprotective effect. [23-25] Viscosupplementation with HA is well established 
internationally as a safe and effective intervention in the management of osteoarthritis.[26-29] 
Furthermore, administration of exogenous HA has been shown to offer significant therapeutic 
benefit within degenerate or compromised peri-articular structures, such as rotator cuff disease 
and lateral ankle sprain.[30-31] HA is secreted by the tendon sheath and, as for joints, allows for 
smooth tendon gliding and contributes to the nutrition of the tendon. Peri-tendinous and intra-
sheath instillation of HA for the treatment of tendon disorders is generating a rapidly growing 
research base, with promising clinical results and few reported adverse events to date.  
 
The natural tendon healing process proceeds along a complex pathway beginning with 
inflammation and cellular proliferation, followed by tissue formation and maturation, with each 
phase lasting days, weeks, and months, respectively. Following tendon damage, a common and 
inevitable complication is the formation of peri-tendinous adhesions; these fibrous 
agglutinations form between the tendon surface and overlying tissues, inhibiting tendon gliding 
and impeding tendon repair.[32] The basic premise of intra-sheath or peri-tendinous HA injection 
is to promote both tendon gliding and the tendon repair process - HA is naturally antagonistic 
towards fibronectin, the pre-cursor to cell-cell adhesions, and plays a crucial role in 
proliferation and differentiation of various cells.[33] Comper et al. found that HA forms a 
macromolecular network which functions as a barrier to the diffusion of fibronectin, thereby 
reducing 
the 
formation 
of 
a 
fibrin 
web, 
which 
in 
turn 
suppresses 
adhesion 
formation.[34] Yoneda et al. found concentrations of more than 1 mg/mL HA inhibit fibroblast 
proliferation, thereby reducing the amount of adhesions.[35] As to the ability of HA to suppress 
adhesion formation yet not impede the healing process, Bentley et al. reported that the natural  
response in surrounding tissue following trauma is an increase in the concentration of 
hyaluronic acid.[36] Hellstrom et al. conclude that HA may help tendon healing process by 
affecting 
the 
orientation 
of 
fibroblasts 
and 
collagen fibres and 
thus 
accelerate 
the reorganisation process of fibrous layers, reducing scar formation and tissue granulation.[37] 
 
Hart et al. conducted a meta-analysis of 41 studies to determine the efficacy and risk of adverse 
effects of peritendinous corticosteroid and other injection therapies in the management of 
tendinopathy.[38] Hart concluded that corticosteroid injection is beneficial in the short term for 
the treatment of tendinopathies but may be worse than other treatments in the intermediate 
and long terms, and that no clear evidence of benefit of other injections was shown, except for 
HA in the short and long terms. Saito et al. conducted a meta - analysis into therapeutic effects 
of subacromial HA injection in patients with chronic shoulder pain.[39] 19 randomised controlled 
trails were included totalling 2,120 patients. The study concluded that HA injection is effective 
for the relief of pain and is a safe alternative to corticosteroid injection for chronic painful 
shoulder. Ostenil™ (HA) has been shown to substantiate these findings in patients presenting 
with primary subacromial impingement syndrome, with Funk et al concluding “HA appears to 
be as effective as depomedrone in reducing subacromial impingement pain but does not 
produce the pain surge associated with depomedrone in the first 72 hours post-injection.”[40] 

5 
 
Petrella et al. evaluated the treatment of 331 competitive racket sport athletes with chronic 
lateral epicondyle tendinopathy (> 3 months) in a double-blind, randomised, placebo-controlled 
trail over a one year period.[41] 2 subcutaneous injections were administered, of either1% 
Sodium Hyaluronate (SH) or saline injection: the first injection at baseline evaluation, the 
second one week later. Post-injection care of rest, ice, compression, and elevation was 
instructed and no formal adjunct physiotherapy was prescribed. VAS pain at rest significantly 
improved in the HA group compared with control, which corresponded to a statistically 
significant improvement in maximal grip strength. These differences persisted at the 90-day 
and 365-day follow-up appointments. Time to return to pain-free and disability-free sport was 
18 days in the HA group, but was not achieved at any time point within the study in the control 
group. 
 
Ostenil Tendon™, a novel, patented 2% concentration of fermentative source HA with the 
addition of Mannitol has previously been shown to relieve pain and improve function in 
patients with partial thickness tears of the supraspinatus tendon and in patients with Achilles, 
lateral epicondyle and peroneal tendinopathies.[42, 43] 
 
 
PLATELET-RICH PLASMA 
 
Platelet-rich plasma (PRP) describes an autologous blood plasma fraction, enriched with 
platelets, thus presenting a high concentration of protein growth factors. The extracted and 
prepared fluid is injected at the sight of tendon injury, theoretically acting as an adjuvant to  
complement and promote the natural healing process. The use of PRP in the management of 
musculoskeletal injuries has increased, based on in vitro studies reporting an enhancement of 
the recruitment, proliferation, and differentiation of the cells involved in muscular tissue 
regeneration.[44] 
 
PRP exerts it effects via the degranulation of the α-granules in platelets, which release various 
fundamental growth factors and cytokines; active secretion is initiated by the blood clotting 
process and begins within 10 minutes of clotting.[45] As the platelets are activated, the growth 
factors are secreted from the cell through the cell membrane, the secreted growth factors 
immediately bind to the external surface of cell membranes within the wound, and in turn 
induce an activation of an endogenous internal signal protein, which causes the expression of a 
specific gene sequence of the cell such as cellular proliferation, matrix formation, osteoid 
production, or collagen synthesis.[44] 
 
Mishra et al. evaluated 140 patients with lateral elbow tendinopathy; patients had initially 
undergone a standardised physical therapy protocol and a variety of nonsurgical treatments. 20 
patients experienced persistent pain and failed to respond adequately, this cohort were then 
given either a single percutaneous injection of platelet-rich plasma or bupivacaine as a 
control.[48] Eight weeks post-injection, the study group reported a 60% improvement in pain 

6 
compared with a 16% improvement in the control group. At six months response within study 
group had increased to 80% improvement. 
 
De Vos et al. recently published a systematic review of PRP injections for chronic lateral 
epicondyle tendinopathy.[46] Five of the six studies included found no significant benefit in the 
study group compared with their respective controls at follow-up. The final study showed a 
beneficial effect compared with corticosteroid injection.  
 
Krogh et al. examined whether a single injection of platelet-rich plasma (PRP) is more effective 
than saline or glucocorticoid in reducing pain in adults with lateral epicondyle tendinopathy at 
three months post-injection.[47] The authors conclude that neither injection of PRP nor 
glucocorticoid was superior to saline with regard to pain reduction in lateral epicondyle 
tendinopathy at the primary end point (3 months), however the study may be criticized due to 
the needling technique used to administer the saline, as this may have a therapeutic effect. 
 
The current study will seek to identify any statistically significant differences in pain and 
function, as evinced by validated objective and subjective measures, in patients with a 
diagnosis of Lateral Epicondyle Tendinopathy/Entheseopathy, following a single, peri-tendinous 
injection into the affected elbow, administered under real time ultra-sonographic imaging, of 
either; 2ml 2% solution of Non-Animal Derived, Non-Chemically Modified Sodium Hyaluronate 
with Mannitol (Ostenil Tendon), or 2ml of PRP prepared with the Biomet Recover Miniplatelet 
System, reported to provide 8x the circulating concentration of platelets, or a subcutaneous 
sham injection under ultrasound control.  All patients will undergo a standardised 
physiotherapy programme post injection. 
 
 
 
Methodology. 
 
Study Design. Prospective, randomised, controlled, double blinded, single centre trial. 
 
Selection Criteria. Invitations to participate in the study will be extended to male and female 
patients, 18 years and above, referred to the Orthopaedic Departments who receive a diagnosis 
of Lateral Condyle Tendinosis (with or without degenerative changes) with symptoms present 
for > 3 months, whose symptoms and clinical evaluation warrant the prescription of a peri-
tendinous injection to relieve symptoms and who are competent to give informed consent.  
 
Demographic data collection 
Age 
Handedness 
Occupation 
Ethnicity 
 
 

7 
Exclusion Criteria. 
 
 Absence of tenderness at the lateral epicondyle. 
 
 Congenital or traumatic bio-mechanical deformities of Elbow complex. 
 
 
 Previous Corticosteroidal, Local Anaesthetic, PRP or Hyaluronic Acid injections to target 
elbow within the last three months. 
 
 Known hypersensitivity to PRP, Hyaluronic acid or any excipients associated with any of 
the prescribed injections. 
 
 Known contra-indication to any treatments constituting normal/appropriate therapy in 
the view of the Consulting clinician. 
 
 Ipsilateral arm pathology severe enough to cause confusion of localised pain perception. 
 
 Pregnancy, lactating women, local infection. 
 
 Pain score less than 4/10 
 
 Patients commenced on medication for the treatment of anxiety or depression within 
the last 6 weeks 
 
 Previous involved in research in last 12 months 
 
 Any progressive, degenerative neuromuscular disorder 
 
Withdrawal Criteria.  
Patients may be withdrawn from the study when: 
 Patient expresses desire to withdraw. 
 Major repeated protocol deviation 
 Non-compliance of patient 
 
 
 

8 
Adverse event and Side Effect Reporting. 
Any adverse event reported by a participating patient to a member of the clinical care team at 
any follow up visit, or between visits to the patient’s GP or other physician will be recorded and 
detailed in an AE report.  The lead investigator will examine the reporting patient as soon as 
possible following the generation of a report and where appropriate, order any tests or 
prescribe such medicines or treatment as deemed to be necessary.  
If any patient is admitted via Accident & Emergency for any reason either connected or 
unconnected with the study, either the lead investigator or a designated member of the clinical 
care team will liaise with the appropriate Consulting clinician.  The details of any reported AE 
will be specified in terms of subjectively reported symptoms and sensations, along with a 
qualified medical opinion from either the lead investigator or a designated member of the 
clinical care team as to likely cause of any signs or symptoms presenting at examination. Where 
diagnostic tests (e.g. blood tests, laboratory cultures) are ordered, a copy of the test results will 
be appended to the patient record card. Following due scrutiny, any side effects in either study 
group will be determined as either; 1. Unrelated to study treatment in any way.  2. Related to 
injection (needle placement, injection site reaction to needling, infection). 3. Related to local 
anaesthetic, as designated on the summary of product characteristics under known side effects. 
4. Related to PRP, as designated on the summary of product characteristics under known side 
effects. 5. Related to Ostenil Tendon™, as designated on the summary of product 
characteristics under known side effects.    
Procedure.  
Recruitment: In order to encourage timely recruitment for this study, local GPs will be informed 
by letter that the study is ongoing and will be sent a copy of the study protocol for their 
information. This will allow GPs to discuss the study with any potentially eligible participants 
presenting to them with Tennis Elbow, to establish if the participant wishes to be referred to 
the host Trust to be offered the opportunity to participate in the study. The GPs will not 
themselves be recruiting patients to the study, and it will be made clear to any patient 
expressing an interest in participation, that their eligibility for inclusion will be decided by their 
treating consultant as described below. 
At their initial outpatient appointment, potential participants will be thoroughly examined by 
their treating consultant or a senior member of the consultant’s team. A clinical diagnosis will 
be confirmed by careful history-taking and examination, and only those patients with a 
diagnosis of lateral epicondylosis, who meet the inclusion criteria, will be informed about the 
study. These individuals will receive a brief verbal explanation of the study by their treating 
clinician and they will also be provided with a copy of the study participant information sheet to 
read at their leisure. Alternatively, any patients eligible for recruitment in this study who had 
already been listed for a PRP injection prior to the start of this study, will be contacted by post 
via the treating consultant’s team, with a copy of the PIS and a covering letter. The letter will 
explain that their consultant has identified that they may be eligible for inclusion in the study 

9 
and they are invited to read the PIS and consider the option of participation. The letter will also 
explain that unless they contact the consultant’s secretary to object, a member of the research 
team will contact them by telephone to establish if they are interested in taking part or if they 
have any questions regarding the content of the PIS. Should they wish to discuss the study 
further with a member of the research team in person, a convenient time for them to attend 
the hospital to do so will be arranged.  
When the patient attends the hospital for their pre-operative assessment, they will then be 
approached by a member of the host Trust research team who will answer any further 
questions they may have about the study procedures and record their informed consent if they 
decide to proceed with participation. 
Consenting participants will be randomised to Study Group A (physio and PRP), Study Group B 
(physio and Ostenil Tendon™), or Control Group C (physio and sham injection) once informed 
consent has been recorded and baseline data has been collected.  
Treatment and follow-up will be the same for those patients who wish to take part in the study 
and for those patients who decline to take part but whose condition makes a peri-tendinous 
injection clinically appropriate. Following informed consent, patients will be assessed for 
demographic detail (age, gender, ethnicity, occupation, affected elbow, height and weight/BMI, 
duration of symptoms, relevant diagnosis, current medication), and given patient completed 
questionnaires to assess pain and function (Oxford Elbow Score (OES), Quick DASH Score, 100 
mm visual analogue pain scale with terminal descriptors), Hospital Anxiety and Depression 
(HAD) Score and asked to complete EQ5D at the initial consultation (V1).  
Treatment: Consenting patients will attend for the injection to be administered under 
ultrasound guidance. All participants will have 30ml of whole venous blood withdrawn under 
aseptic conditions.   
Out of sight of the patient the whole venous blood will either be; 
placed in the cell separator and centrifuged at 32000 rpm for 15 minutes for subjects in group 
A.  During the centrifugation process 2ml of 2% plain lidocaine will be injected into the 
subcutaneous layer at the site of injection of the PRP.  One millilitre (2ml) of PRP produced will 
be drawn into a syringe wrapped in silver foil and injected under ultrasound control via a blue 
(20 gauge) hypodermic needle into the lateral epicondyle using a peppering technique. 
Or 
discarded for those in group B and C.  The centrifuge will be set to run at 32000rpm for 15 
minutes with a saline counterbalance.    During the centrifugation process 2ml of 2% plain 
lidocaine will be injected into the subcutaneous layer at the site of injection.  For those in group 
B a pre-prepared “Ostenil Tendon” syringe will be wrapped in silver foil and 2ml will be injected 
into the peri-tendinous area via a blue (20 gauge) hypodermic needle under ultrasound control. 

10 
For those in group C an empty syringe wrapped in silver foil with a blue (20 gauge) hypodermic 
needle will be used to perform a sham injection into the subcutaneous tissue only by passing 
the needle into the tissue with no injectate. 
During the procedure the patient will be distracted by being asked to confirm their personal 
details. 
Patients will be given pain report diaries which will be completed on days 1, 2, 3, 7, and 14, and 
at 6 weeks, 12 weeks (final clinical follow up visit prior to discharge). Patients will be taught 
home exercises by a blinded physiotherapist prior to discharge, a formal class based 
physiotherapy programme will commence at 5-15 days post injection.  The patient will be 
assessed by a blinded clinician at 3 months and 12 months post treatment. Telephone follow-up 
calls will be made to patients 3 months and 12 months post treatment if the patient declines to 
attend a follow-up appointment.  The Consulting physician will discharge patients from his 
direct care at 12 weeks unless enduring or subsequently manifesting symptoms persist. Pain 
scores, amount of rescue medication (codeine & Paracetamol) and QOL questionnaires will be 
completed at all visits. The OES, qDASH, HAD and EQ5D will be completed at 3 and 12 month 
reviews. 
Patients who successfully complete both 3 month and 12 months outcome questionnaires with 
be entered into a raffle to win an iPad tablet computer. 
Primary Measure of Outcome. 
The difference in Objective Functional Assessment as evinced by Quick DASH, at 12 months 
Secondary Measures of Outcome. 
The difference in Objective Pain and Functional Assessment as evinced by OES and 100 point 
VAS with terminal descriptors at 12 months 
Change in EQ5D General Health Questionnaire. 
Relationship of pre-injection HAD score to outcome.   
Change in HAD score at 12months 
Use of Rescue Medication. 
 
 
 

11 
Number of Patients.  
The proposed randomized controlled double blind (single centre) trial design will have 80% 
power (1-β) to reject the null hypothesis, with an α (type I error, i.e. level of statistical 
significance) set at 0.05. Assuming a clinically significant [mean] difference (δ) of 15 Q-DASH 
score units between groups together with an estimated sample standard deviation (σ) of 22.5 
(Biomet study – based on Q-DASH score for PRP arm) which gives an ‘n’ for each trial arm 
(assuming equal group sizes) of at least 35 analyzable patients in each of the three groups (A,B 
&C) and given a possible attrition rate of about 16% the CITTE trial will probably therefore need 
a total sample size of at least 123 of patients, approximately. 
Statistical Analysis.  
All quantitative data - age, gender, duration of symptoms, disease progression, target joint, 
Height, weight and BMI, will be analysed using the most appropriate non-parametric tests. VAS, 
qDASH and OES score Inventories, EQ5D, Blinded Assessor and escape medication scores will be  
tested for homogeneity of variance (Chi sq/F test), mean scores calculated, and then either t 
tested (with possible ANOVA for correlations between pain, function, strength etc) or Mann-
Whitney/ Wilcoxon rank sum (Kruskall Wallis differences /Jonkheere trend).  
Interventions 
Physiotherapy protocol 
 
After the injection and prior to discharge a physiotherapist will teach patients eccentric loading 
exercises of the wrist extensors.  They will be instructed to commence the exercises at day 1 
post injection.  They will be advised to carry out 3 sets of 15 repetitions, 3 times per day.  An 
accompanying exercise sheet will advise to increase the load as symptoms permit.  It will be 
suggested to commence with a half filled 500ml bottle of water.  In addition a simple common 
extensor stretch will be taught to use following the eccentric exercises.   
 
At 5-15 days post injection the patients will commence an out-patient class based  
physiotherapy programme.  The class will be held 2 weekly by a blinded physiotherapist.  After 
being taught the exercises on an 1:1 basis, the patients will be supervised during a circuit style 
exercise programme. The exercise programme will include eccentric loading of the common 
extensors, and upper limb strengthening involving the full kinetic chain, in particular the rotator 
cuff and scapular muscles.  Each patient will be supervised and monitored to improve 
technique, and to increase the load.  Patients will be provided with a home exercise programme 
which will reflect the class exercises.   
Study GROUP A Product Dose, Presentation, and Mode of Administration. 
2ml unbuffered PRP prepared with Zimmer/Biomet Recover Mini-platelet system administered 
via intratendinous injection under ultrasound. 

12 
Study GROUP B Product Dose, Presentation, and Mode of Administration. 
Ostenil™ Tendon (40mg/2ml of bio-fermentation source Sodium Hyaluronate with 10mg 
Mannitol in a pre-filled syringe). To be administered via peritendinous injection under 
ultrasound. 
Licensed indication in the EU: For the treatment of pain and restricted mobility in tendon 
disorders.  
Active Ingredient;  Sodium Hyaluronate / Mannitol 
Excipients Sodium Chloride, Sodium Monohydrogenphosphate, Sodium Dihydrogenphosphate, 
water for injection. 
Distributor:  TRB CHEMEDICA (UK) LTD 
9 Evolution 
Lymedale Business Park  
Hooters Hall Road 
Newcastle-under-Lyme 
Staffordshire 
ST5 9QF  
 
Direct contact; Mr. Alex Flanagan 
                        Clinical Research Director. 
                        Mob; 07817 677103 
                        aflanagan@trbchemedica.co.uk 
 
Study Group C Product Dose, Presentation, and Mode of Administration. 
A sham injection under ultrasound control. No fluid will be instilled. 
 
 
Pain Relief Controls 
 
All patients will be asked not to take NSAID for a week before and two weeks after injection. 
Paracetamol 1g QDS and codeine phosphate up to 30mg QDS will be permitted. 
 
 
 
 
 
 
 
 
 

13 
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