Achilles tendon pain management (ATM): A study to evaluate an injection to improve pain in the Achilles tendon
| ISRCTN | ISRCTN13254422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13254422 |
| IRAS number | 187315 |
| Secondary identifying numbers | CPMS 19870, IRAS 187315 |
- Submission date
- 28/10/2015
- Registration date
- 28/10/2015
- Last edited
- 08/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Current plain English summary as of 04/06/2019:
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 heel 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 speed up healing and reduce pain in patients with mid-substance Achilles tendinopathy.
Who can participate?
People aged 18 years 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 weeks, 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. The risks 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 September 2020
Who is funding the study?
Arthritis Research UK (UK), now known as “Versus Arthritis”
Who is the main contact?
1. Jaclyn Brown (Public)
2. Dr Rebecca Kearney (Scientific)
Previous plain English summary as of 29/04/2019:
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 heel 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 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 weeks, 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. The risks 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 August 2020
Who is funding the study?
Arthritis Research UK (UK), now known as “Versus Arthritis”
Who is the main contact?
1. Mariana Bernardo (Public)
2. Dr Rebecca Kearney (Scientific)
Previous plain English summary as of 30/11/2018:
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 heel 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 weeks, 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. The risks 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 August 2020
Who is funding the study?
Arthritis Research UK (UK), now known as “Versus Arthritis”
Who is the main contact?
1. Bushra Rahman (Public)
2. Dr Rebecca Kearney (Scientific)
Previous 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 heel 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 weeks, 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. The risks 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)
Contact information
Public
Clinical Trials Unit – Orthopaedics
Clinical Sciences Building
Clinical Sciences Research Laboratories
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| Phone | +44 2476 968 622 |
|---|---|
| ATM@warwick.ac.uk |
Scientific
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0002-8010-164X |
|---|
Study information
| Study design | Randomized; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | ATM |
| Study objectives | 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(s) | National Research Ethics Service Committee – The Black Country, 30/10/2015, ref: 15/WM/0359 |
| Health condition(s) or problem(s) studied | Achilles tendinopathy |
| 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 |
| 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 study start date | 01/09/2015 |
| Completion date | 29/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 240; UK Sample Size: 240; Description: 1:1 |
| Total final enrolment | 240 |
| Key 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 3 months 4. Ultrasound and/or MRI confirmation of tendinopathy |
| Key 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 6 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. |
| Date of first enrolment | 01/06/2016 |
| Date of final enrolment | 21/02/2020 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Dundee
DD2 1UB
United Kingdom
Colney Lane
Norwich
NR4 7UY
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Apley Castle
Grainger Drive
Telford
TF1 6TF
United Kingdom
Rake Lane
Tyne and Wear
North Shields
NE29 8NH
United Kingdom
Middlewich Road
Crewe
CW1 4QJ
United Kingdom
Heol Maes Eglwys
Morriston
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
Arrowe Park Road
Upton
Birkenhead
CH49 5PE
United Kingdom
Wexham Street
Slough
SL2 4HL
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Gobowen
Oswestry
SY10 7AG
United Kingdom
Thorne Road
Doncaster
DN2 5LT
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Parkfield Drive
Taunton
TA1 5DA
United Kingdom
Gurnos Road
Merthyr Tydfil
CF47 9DT
United Kingdom
Nethermayne
Basildon
SS16 5NL
United Kingdom
College Street
Nuneaton
CV10 7DJ
United Kingdom
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom
Penlan Road
Llandough
CF64 2XX
United Kingdom
Woodrow Drive
Redditch
B98 7UB
United Kingdom
Newall Carr Road
Otley
LS21 2LY
United Kingdom
Praed Street
Paddington
London
W2 1NY
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
England
United Kingdom
"ROR" |
https://ror.org/01a77tt86 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/02/2020 | 14/02/2020 | Yes | No |
| Results article | 13/07/2021 | 14/07/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol (other) | 13/07/2021 | 08/11/2023 | No | No | |
| Statistical Analysis Plan | 13/07/2021 | 08/11/2023 | No | No |
Editorial Notes
08/11/2023: Protocol and statistical analysis plan added.
03/09/2021: Acronym added.
14/07/2021: Publication reference added.
29/09/2020: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2020 to 29/09/2020.
2. The total final enrolment was changed from 241 to 240.
23/03/2020: The following changes have been made:
1. The overall trial end date has been changed from 28/02/2020 to 30/09/2020.
2. The intention to publish date has been changed from 31/01/2022 to 31/03/2021.
3. The plain English summary has been updated to reflect the changes above.
05/03/2020: The following changes were made to the trial record:
1. The overall end date was changed from 31/01/2021 to 28/02/2020.
2. The intention to publish date
3. The total final enrolment was added.
4. The plain English summary was updated to reflect these changes.
24/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2020 to 21/02/2020.
2. The IRAS number has been added.
14/02/2020: Publication reference added.
05/12/2019: The following changes have been made:
1. The recruitment end date has been changed from 30/11/2019 to 31/05/2020.
2. The overall trial end date has been changed from 31/08/2020 to 31/01/2021.
3. The intention to publish date has been changed from 31/08/2020 to 31/01/2022.
4. The public contact has been changed.
04/06/2019: The plain English summary and public contact have been updated.
29/04/2019: The plain English summary and public contact have been updated.
02/04/2019: The condition has been changed from "Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal Pain Disorders" to "Achilles tendinopathy" following a request from the NIHR.
30/11/2018: The following changes were made:
1. The plain English summary was updated.
2. The primary contact was updated.
3. 18 trial participating centres were added.
4. The recruitment end date was changed from 31/01/2019 to 30/11/2019.
5. The overall trial end date was changed from 31/12/2019 to 31/08/2020.
6. The intention to publish date was changed from 30/11/2019 to 31/08/2020.
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
