Achilles Tendinopathy Management: platelet-rich plasma versus eccentric loading programme
| ISRCTN | ISRCTN95369715 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95369715 |
| Secondary identifying numbers | PRF/09/2 |
- Submission date
- 22/12/2009
- Registration date
- 18/02/2010
- Last edited
- 05/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Matthew Costa
Scientific
Scientific
Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| matthew.costa@warwick.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Achilles Tendinopathy Management: a randomised controlled trial comparing platelet-rich plasma with an eccentric loading programme |
| Study acronym | ATM |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 01/02/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warwick Medical School
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
University/education
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 | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Research organisation
Physiotherapy Research Foundation (UK) (ref: PRF/09/2)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/10/2013 | Yes | No |
