Contact information
Type
Scientific
Contact name
Mr Matthew Costa
ORCID ID
Contact details
Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
matthew.costa@warwick.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PRF/09/2
Study information
Scientific title
Achilles Tendinopathy Management: a randomised controlled trial comparing platelet-rich plasma with an eccentric loading programme
Acronym
ATM
Study hypothesis
There is no difference in Victorian Institute of Sports Assessment - Achilles (VISA-A) scores at 6 months between patients initially managed with platelet-rich plasma injections compared to patients managed with an eccentric loading programme.
Ethics approval(s)
Coventry Research Ethics Committee, 20/03/2009, ref: 09/H1210/18
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Achilles tendinopathy
Intervention
Intervention:
Platelet Rich Plasma Injection. The procedure will involve taking 52 ml of whole blood combined with 8 ml of an anti-coagulant which will be immediately centrifuged at 2400 for 12 minutes. After centrifugation the platelet layer (approximately 3 - 5 ml) will be extracted using a syringe and then injected into the Achilles tendinopathy.
Comparison:
Eccentric Loading Programme, involving two exercises. The first involves the patient being in a standing position with the heel over the edge of a step with the legs straight. The patient then slowly lowers their heels beyond the level of the step. The second exercise follows the same sequence but with the knee slightly bent, to maximise activation of the soleus muscles. These exercises are performed three times a day, 7 days a week for 12 weeks and are progressed as pain allows by adding weight via a back pack.
Secondary Sponsor Details:
University Hospitals of Coventry and Warwickshire NHS Trust
Research and Development Department
Clifford Bridge Road
Coventry CV4 8UW
United Kingdom
Intervention type
Other
Primary outcome measure
VISA-A at 6, 12, 24, 30, 36 and 52 weeks
Secondary outcome measures
EQ-5D and complications at 6, 12, 24, 30, 36 and 52 weeks
Overall study start date
01/02/2010
Overall study end date
01/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Midsubstance achilles tendinopathy diagnosed clinically through pain on palpation at a level of 2 - 6 cm above the tendon insertion and ultrasonography
2. The tendinopathy will be causing pain during loading activities and limit those activities
3. Duration of at least 3 months
4. Aged over 18 years, either sex
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
20
Participant exclusion criteria
1. Tendinopathies secondary to systemic conditions such as rheumatoid arthritis and diabetes
2. Insertional Achilles tendinopathies
3. Pregnancy
4. Previous Achilles rupture or surgery
5. Dislocation or fracture of the lower limb within the preceeding 12 months
Recruitment start date
01/02/2010
Recruitment end date
01/02/2012
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Warwick Medical School
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
c/o Grants and Contracts Officer
Research Support Services
University House
Kirby Corner Road
Coventry
CV4 7AL
England
United Kingdom
N.K.Bains@warwick.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Research organisation
Funder name
Physiotherapy Research Foundation (UK) (ref: PRF/09/2)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/10/2013 | Yes | No |