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

Phase 4

Not yet recruiting

• Conditions: Insertional Achilles Tendinopathy
• Interventions: Device: ESWT; Biological: PRP

• Registration Number: NCT06384859
• Lead Sponsor: Mahidol University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Study Start: 2024-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWT + PRP	ESWT	Receive ESWT once a week for 4 weeks and PRP injection at a week later
ESWT	ESWT	Receive ESWT once a week for 4 weeks
ESWT + PRP	PRP	Receive ESWT once a week for 4 weeks and PRP injection at a week later

Primary Outcome Measures

Name	Time	Method
VAS	6 week, 3 months, 6 months and 1 year after treatment	Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
VAS-FA	6 week, 3 months, 6 months and 1 year after treatment	Visual analogue scale foot and ankle
FFI	6 week, 3 months, 6 months and 1 year after treatment	Foot functional index
FAAM	6 week, 3 months, 6 months and 1 year after treatment	Foot and Ankle Ability Measure

Trial Locations

Locations (1)

Ramathibodi hospital; 🇹🇭 Ratchathewi, Bangkok, Thailand