Condition category
Musculoskeletal Diseases
Date applied
22/12/2009
Date assigned
18/02/2010
Last edited
05/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2010

Overall trial end date

01/02/2012

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom
N.K.Bains@warwick.ac.uk

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24135556

Publication citations

  1. Results

    Kearney RS, Parsons N, Costa ML, Achilles tendinopathy management: A pilot randomised controlled trial comparing platelet-richplasma injection with an eccentric loading programme., Bone Joint Res, 2013, 2, 10, 227-232, doi: 10.1302/2046-3758.210.2000200.

Additional files

Editorial Notes