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Achilles tendon pain management (ATM): A study to evaluate an injection to improve pain in the Achilles tendon

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13254422
Enrollment
240
Registered
2015-10-28
Start date
2016-06-01
Completion date
Unknown
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles tendinopathy Musculoskeletal Diseases Achilles tendinitis

Interventions

Participants are randomly allocated to one of two groups: Control group: Participants receive a placebo injection into the skin near the painful tendon Intervention g

Sponsors

University of Warwick
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactBethany Foster
ATM@warwick.ac.uk+44 2476 968 622

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026