Tennis elbow platelet-rich plasma injection study
| ISRCTN | ISRCTN12951626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12951626 |
| Secondary identifying numbers | 17180 |
- Submission date
- 15/07/2015
- Registration date
- 16/07/2015
- Last edited
- 15/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Robert Jones & Agnes Hunt Orthopaedic & District Hospital
ARC Building
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
Study information
| Study design | Randomized; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A pilot study of platelet-rich plasma (PRP) versus autologous whole blood versus saline in the treatment of resistant tennis elbow |
| Study acronym | TEPIS |
| Study objectives | 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(s) | First MREC approval date 22/08/2014, ref: 14/WM/1063; |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Platelet-rich plasma injection |
| Primary outcome measure | 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 study start date | 09/03/2015 |
| Completion date | 17/03/2021 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 30; UK Sample Size: 30 |
| Total final enrolment | 29 |
| Key inclusion criteria | 1. Established lateral epicondyle tendinopathy with a minimum symptom duration of 3 months 2. Aged 18 years or above and below 65 years 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 |
| Key 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 |
| Date of first enrolment | 09/03/2015 |
| Date of final enrolment | 01/04/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom
Sponsor information
Hospital/treatment centre
The Robert Jones and Agnes Hunt Orthopaedic Hospital
Twmpath Lane
Oswestry
SY10 7AG
England
United Kingdom
"ROR" |
https://ror.org/030mbcp39 |
|---|
Funders
Funder type
Government
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
15/01/2025: The study terminated early due to COVID-19. The overall study end date was changed from 01/04/2016 to 17/03/2021. Total final enrolment added.
31/05/2018: No publications found, verifying study status with principal investigator.
