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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list