Condition category
Musculoskeletal Diseases
Date applied
15/07/2015
Date assigned
16/07/2015
Last edited
16/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Dr Johanna Wales

ORCID ID

Contact details

Robert Jones & Agnes Hunt Orthopaedic & District Hospital
ARC Building
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom

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

Sponsor information

Organisation

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Sponsor details

The Robert Jones and Agnes Hunt Orthopaedic Hospital
Twmpath Lane
Oswestry
SY10 7AG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes