Plain English Summary
Background and study aims
Tennis elbow is a common condition that causes lateral elbow pain. It is associated with repetitive activity at work and play and is thought to be caused by micro-tears in the tendons of the elbow. Although many cases resolve over a period of 3 months, either with or without non-surgical treatments such as rest, exercises and bracing, other treatments may be necessary such as corticosteroid injections or surgery. In an autologous blood injection, blood is taken from the patient and re-injected around the affected tendon. Either whole blood can be injected, or a fragment known as platelet-rich plasma (PRP) can be separated from the red blood cells and injected. PRP contains a high level of growth factors which are thought to stimulate the healing process. The primary aim of this study is to assess feasibility and guide the planning of a large multi-centre study to investigate both the clinical and cost effectiveness of PRP as a treatment for tennis elbow. Three treatment options will be investigated; an injection of either whole blood, PRP or saline using a technique called needle barbotage that disrupts tendon fibres and promotes the healing process.
Who can participate?
Patients aged between 18-65 attending Robert Jones and Agnes Hunt Orthopaedic Hospital with symptoms of Tennis Elbow.
What does the study involve?
Participants are allocated to one of three groups at random. Those in group 1 are given a whole blood injection. Those in group 2 are given PRP. Those in group 3 are given saline. Assessments of pain and elbow function are carried out at 6 weeks, 12 weeks, 6 months and 1 year.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
March 2015 to April 2016
When is the study starting and how long is it expected to run for?
Robert Jones & Agnes Hunt Orthopaedic & District Hospital, Oswestry (UK)
Who is funding the study?
The British Elbow & Shoulder Society (BESS), Lavender Medical and The Orthopaedic Institute Limited.
Who is the main contact?
Dr Johanna Wales
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17180
Study information
Scientific title
A pilot study of platelet-rich plasma (PRP) versus autologous whole blood versus saline in the treatment of resistant tennis elbow
Acronym
TEPIS
Study hypothesis
The primary aim of this study is to assess feasibility and guide the planning of a large multi-centre study to investigate both the clinical and cost effectiveness of platelet-rich plasma (PRP) as a treatment for tennis elbow. Three treatment options will be investigated; an injection of either whole blood, PRP or saline using a technique called needle barbotage that disrupts tendon fibres and promotes the healing process. Patients will be allocated to one of the treatment groups at random.
Ethics approval
First MREC approval date 22/08/2014, ref: 14/WM/1063;
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
Injection of either whole blood, platelet-rich plasma or saline using a technique called needle barbotage that disrupts tendon fibres and promotes the healing process
Follow Up Length: 12 month(s)
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measures
Patient rated tennis elbow evaluation (PRTEE); Timepoint(s): 12 weeks post-injection
Secondary outcome measures
1. Adverse events; Timepoint(s): peri-procedural, 6 weeks, 12 weeks, 6 months and 12 months
2. Disabilities of the arm, shoulder and hand (DASH) questionnaire; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months
3. EQ-5D; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months
4. Health economic data (resourse usage); Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months; 5. Loss to follow-up and withdrawal rates; Timepoint(s): 12 months
6. Mayo elbow performance indicator (MEPI); Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months; Recruitment rate; Timepoint(s): 12 months
7. Visual analogue pain score; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months
Overall trial start date
09/03/2015
Overall trial end date
01/04/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Established lateral epicondyle tendinopathy with a minimum symptom duration of 3 months
2. Aged 18 or above and below 65
3. Willing to avoid the use of topical and oral nonsteroidal anti-inflammatory drugs for a period of 6 weeks following injection
4. Has completed the study physiotherapy program for a minimum period of 6 weeks with no improvement in symptoms
Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Participant exclusion criteria
1. Bilateral tennis elbow
2. Currently taking part in any interventional study that may impact upon study outcomes.
3. A concomitant injury that may impact on the ability to complete outcome assessments
4. Previous surgical intervention of the tendinopathy
5. Inflammatory disease, or chronic widespread pain syndrome
6. Requires regular use of anti-inflammatory medication for complaints other than Tennis Elbow
7. Known platelet dysfunction or thrombocytopaenia, or haemodynamic instability
8. Malignancy
9. Unable or unwilling to complete the 12 month follow-up assessments
10. Unable to communicate fluently in English or an inability to respond to validated questionnaires written in the English language
11. Platelet count <105/microlitre
12. Corticosteroid injection at the treatment site within the last 4 weeks, or systemic use of corticosteroids within the last 2 weeks. Anti-coagulation therapy within 5 days before treatment
13. Treatment with Non-steroidal anti-inflammatory drugs within 1 week prior to treatment
14. Septicaemia or fever
Recruitment start date
09/03/2015
Recruitment end date
01/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Robert Jones & Agnes Hunt Orthopaedic & District Hospital
ARC Building
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
Funders
Funder type
Government
Funder name
British Elbow & Shoulder Society (BESS)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Lavender Medical
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Orthopaedic Institute Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary