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

NCT06384859 | Not Yet Recruiting Phase 4

• 1 other identifier: Pending
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Insertional Achilles Tendinopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• VAS

  Visual Analogue Scale

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

Secondary Outcomes (3)

• 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 Arms (2)

ESWT + PRP

EXPERIMENTAL

Receive ESWT once a week for 4 weeks and PRP injection at a week later

Device: ESWT; Biological: PRP

ESWT

ACTIVE COMPARATOR

Receive ESWT once a week for 4 weeks

Device: ESWT

Interventions

ESWT DEVICE

Receive ESWT once a week for 4 weeks

ESWT; ESWT + PRP

PRP BIOLOGICAL

Receive PRP injection at week 5

ESWT + PRP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ramathibodi hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 25, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TH (1)