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 skin near the painful tendon. At the start of the study and then again after 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?
Six NHS hospitals in England (UK)
When is the study starting and how long is it expected to run for?
June 2016 to September 2020
Who is funding the study?
Arthritis Research UK (UK)
ATM Data Transparency Statement
The University of Warwick is the sponsor for this study based in the United Kingdom and will act as the data controller for this study. The relevant Data Protection Officer is Anjeli Bajaj. We will be using information from you and your medical records in order to undertake this study. This means that we are responsible for looking after your information and using it properly.
The only people in the University of Warwick who will have access to information that identifies you will be people who need to contact you to collect follow up data, missing data, safety data or remind you to return your follow up questionnaire or audit the data collection process. The way we contact you may vary throughout the trial, however, you will only be contacted via the methods you agreed when you gave consent to take part in the study. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details. The legal basis for processing this information under the GDPR is undertaking a task (research) in the public interest. The University of Warwick will keep identifiable information about you for at least 10 years after the study has finished and your personal data will not be shared or disclosed to any external third parties.
The University of Warwick will process your next of kin’s personal data; their name, address and phone number for the purpose(s) of making contact with them in relation to your participation in this clinical trial if we are unable to contact you. The legal basis for processing this personal data is for the purpose of legitimate interest. Your next of kin’s personal data will not be shared or disclosed to any third parties external to the University of Warwick and will be retained for 12 months after the end of the study.
Please inform your next of kin of the above information if they are not already aware. You can update all contact information directly with the ATM trial office at any time. Please see our website for trial contacts: https://warwick.ac.uk/fac/sci/med/research/ctu/trials/recruiting;
Your NHS hospital site will collect information from you and your medical records for this research study in accordance with our instructions. Your NHS hospital site will use your name and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from The University of Warwick and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your NHS hospital site and you will pass these details to the University of Warwick. Your NHS hospital site will keep identifiable information about you from this study for at least 10 years after the study has finished.
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/
This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how the University of Warwick use your information along with the Data Protection Officer’s Contact information here: https://warwick.ac.uk/services/idc/dataprotection/privacynotices/researchprivacynotice