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NCT Number: NCT06384859

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

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

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Key information

Conditions

Insertional Achilles Tendinopathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ESWT

Device

Receive ESWT once a week for 4 weeks

PRP

Biological

Receive PRP injection at week 5

Primary outcomes

  1. VAS

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

    Visual Analogue Scale

Secondary outcomes

  1. VAS-FA

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

    Visual analogue scale foot and ankle

  2. FFI

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

    Foot functional index

  3. FAAM

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

    Foot and Ankle Ability Measure

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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