Condition category
Musculoskeletal Diseases
Date applied
28/10/2015
Date assigned
28/10/2015
Last edited
21/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Every year more than 150,000 people suffer from pain at the back of the heel, leading to walking difficulties. The most common cause of this is Achilles tendinopathy, also known as Achilles tendonitis. Achilles tendinopathy is a condition where the Achilles tendon becomes damaged, causing pain, swelling and stiffness. The Achilles tendon is a very strong band of tissue which connects the calf muscle to the heal bone. There are two main areas that are affected, the middle of the tendon (mid-substance Achilles tendinopathy) and where the tendon meets the heel bone (insertional Achilles tendinopathy). Mid-substance Achilles tendinopathy is thought to happen when the tendon is unable to repair itself after it has been injured. Currently, the main treatments for Achilles tendinopathy involve a combination of self-help techniques, physical therapy, medications and even surgery, although the most effective treatment is widely debated. Platelet rich plasma (PRP) is a part of the blood plasma (the liquid part of the blood) with a high platelet concentration. Platelets are blood components which play an important role in the healing process. The aim of this study is to find out whether injections of PRP can help to speed up healing and reduce pain in patients with mid-substance Achilles tendinopathy.

Who can participate?
People aged 18 or over, who have been suffering from painful Achilles tendons for more than three months.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have a blood sample taken, which is spun in a machine to separate out the components of the blood. The PRP is then injected into the skin near the painful tendon. Participants in the second group are given a placebo (imitation) injection into the painful tendon. At the start of the study and then again after two week, three and six months, participants in both groups complete questionnaires in order to find out whether there has been any change to their pain levels and ability to perform activities.

What are the possible benefits and risks of participating?
Participants may benefit from reduced pain due to the PRP injection. Risks of of participating are minor, however participants may experience pain, swelling or bleeding, skin discolouration and possible allergic reaction to the PRP injection.

Where is the study run from?
NHS hospitals in England (UK)

When is the study starting and how long is it expected to run for?
June 2016 to January 2019

Who is funding the study?
Arthritis Research UK (UK)

Who is the main contact?
1. Dr Joanne O'Beirne-Elliman (Public)
2. Dr Rebecca Kearney (Scientific)

Trial website

http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/musculoskeletalandpain/atm

Contact information

Type

Public

Primary contact

Dr Joanne O'Beirne-Elliman

ORCID ID

Contact details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Type

Scientific

Additional contact

Dr Rebecca Kearney

ORCID ID

http://orcid.org/0000-0002-8010-164X

Contact details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19870

Study information

Scientific title

Achilles tendinopathy management (ATM): A multi-centre placebo-controlled randomised trial comparing platelet rich plasma (PRP) to placebo injection in adults with Achilles tendon pain

Acronym

Study hypothesis

The aim of this study is to investigate whether plasma rich injection (PRP) can help to increase healing and reduce pain in patients with painful Achilles tendons. In adults with painful mid-substance Achilles tendinopathy lasting longer than three months, does a single injection of platelet rich plasma improve VISA A scores by a minimum of 12 points when compared to a placebo injection at six months post injection?

Ethics approval

National Research Ethics Service Committee – The Black Country, 30/10/2015, ref: 15/WM/0359

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal Pain Disorders

Intervention

Participants are randomly allocated to one of two groups:

Control group: Participants receive a placebo injection into the skin near the painful tendon

Intervention group: Participants have a blood sample taken which is then spun in a centrifuge to separate out the blood components and collect platelet rich plasma (PRP). They then receive a PRP injection into the painful tendon

Participants in both groups are followed up at 2 weeks, 3 and 6 months, in which the severity of their Achilles tendinopathy and quality of life is measured.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Dysfunction of the Achilles tendon (pain, function and activity) is measured using the Victorian institute of sport assessment-Achilles (VISA-A) questionnaire at baseline, 3 months and 6 months.

Secondary outcome measures

1. Health related quality of life is measured using the EQ5D-5L questionnaire at baseline, 3 months and 6 months

Added 19/10/2016:
2. Pain is measured using a visual analogue score (VAS) is assessed at baseline, 2 weeks, 3 and 6 months using a patient questionnaire
3. Complications are recorded at 2 weeks, 3 and 6 months using a patient questionnaire

Overall trial start date

01/09/2015

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Provision of written informed consent
2. Aged 18 years or over
3. Pain at the mid-substance of the Achilles tendon for longer than three months
4. Ultrasound and/or MRI confirmation of tendinopathy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 240; UK Sample Size: 240; Description: 1:1

Participant exclusion criteria

1. Presence of systemic conditions (including: diabetes, rheumatoid arthritis, peripheral vascular disease)
2. Pregnant or actively trying to become pregnant, or breastfeeding at the time of randomisation
3. Have had prior Achilles tendon surgery or rupture on the index side
4. Previous major tendon or ankle injury or deformity to either lower leg
5. Have had a fracture of a long bone in either lower limb in the previous six months
6. Have any contraindication to receiving a platelet rich plasma injection (haemodynamic instability, platelet dysfunction syndrome, cancer, septicaemia, systemic use of anticoagulant, local infection at site of the procedure)
7. Are unable to adhere to trial procedures or complete questionnaires
8. Previous randomisation in the present trial

Added 19/10/2016:
9. Previous PRP treatment into a tendon.

Recruitment start date

01/06/2016

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Coventry
University Hospitals Coventry and Warwickshire Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Ninewells Hospital and Medical School
NHS Tayside
Dundee
DD2 1UB
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Norfolk and Norwich University Hospitals NHS Foundation Trust Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Northern General Hospital
Sheffield Teaching Hospitals NHS Foundation Trust Herries Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Leicester General Hospital
University Hospitals of Leicester NHR Trust Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Trial participating centre

The Princess Royal Hospital
Shrewsbury and Telford Hospital NHS Trust Apley Castle Grainger Drive
Telford
TF1 6TF
United Kingdom

Sponsor information

Organisation

University of Warwick

Sponsor details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Arthritis Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A summary of the trial outcomes will be disseminated to trial participants on relevant websites and newsletters. A final report to Arthritis Research UK will be produced in addition to publications in peer-reviewed medical journals and presentations at relevant conferences. The results may also contribute to future NICE guidance on the topic of platelet rich plasma injections.

IPD Sharing plan:
The data will be held at Warwick Clinical Trials Unit in accordance with their Standard Operating Procedures on storing and sharing data.

Intention to publish date

30/11/2019

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/11/2016: The availability of participant level data has been added. 19/10/2016: The following changes have been made for the record: 1. The participant inclusion criteria has been edited so that only participants over the age of 18 (previously 16) can participate 2. Two additional secondary outcome measures have been added 3. An additional exclusion criteria has been added 4. Addenbrooke's hospital has been replaced with Ninewells Hospital and Medical School, Royal Hallamshire HospitalNorthern has been replaced with Northern General Hospital, and Leicester Royal Infirmary has been replaced with Leicester General Hospital in the list of trial participating centres