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Clinical Trials/NCT06384859
NCT06384859
Not yet recruiting
Phase 4

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

Mahidol University1 site in 1 country94 target enrollmentMay 1, 2024

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Insertional Achilles Tendinopathy
Sponsor
Mahidol University
Enrollment
94
Locations
1
Primary Endpoint
VAS
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
May 1, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

VAS

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

Visual Analogue Scale

Secondary Outcomes

  • VAS-FA(6 week, 3 months, 6 months and 1 year after treatment)
  • FFI(6 week, 3 months, 6 months and 1 year after treatment)
  • FAAM(6 week, 3 months, 6 months and 1 year after treatment)

Study Sites (1)

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