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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMahidol University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • ESWT

    Device

    Receive ESWT once a week for 4 weeks

  • PRP

    Biological/Vaccine

    Receive PRP injection at week 5

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: ESWT + PRPExperimental treatment 2 interventions
Group B: ESWTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

VAS

Visual Analogue Scale

Time frame
6 week, 3 months, 6 months and 1 year after treatment

Secondary outcomes

1

VAS-FA

Visual analogue scale foot and ankle

Time frame
6 week, 3 months, 6 months and 1 year after treatment
2

FFI

Foot functional index

Time frame
6 week, 3 months, 6 months and 1 year after treatment
3

FAAM

Foot and Ankle Ability Measure

Time frame
6 week, 3 months, 6 months and 1 year after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: