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Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy

Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06384859
Enrollment
94
Registered
2024-04-25
Start date
2024-05-01
Completion date
2027-05-01
Last updated
2024-04-25

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

Conditions

Insertional Achilles Tendinopathy

Keywords

chronic insertional Achilles tendinopathy, extracorporeal shockwave therapy, platelet rich plasma

Brief summary

The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are: Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment? Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy. Participants will: * Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks * Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score

Interventions

DEVICEESWT

Receive ESWT once a week for 4 weeks

BIOLOGICALPRP

Receive PRP injection at week 5

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with insertional Achilles tendinopathy * Had symptom more than 6 months * Failed other standard conservative treatment (rest, medication, activity modification, stretching exercise, and heel lift orthosis)

Exclusion criteria

* Receive corticosteroid injection at the Achilles insertion * History of infection around ankle and heel * Has neurological deficit * Has a contraindication for ESWT(hemophilia, coagulopathy or foot and ankle malignancy)

Design outcomes

Primary

MeasureTime frameDescription
VAS6 week, 3 months, 6 months and 1 year after treatmentVisual Analogue Scale

Secondary

MeasureTime frameDescription
VAS-FA6 week, 3 months, 6 months and 1 year after treatmentVisual analogue scale foot and ankle
FFI6 week, 3 months, 6 months and 1 year after treatmentFoot functional index
FAAM6 week, 3 months, 6 months and 1 year after treatmentFoot and Ankle Ability Measure

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026