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

NCT ID: NCT06384859

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESWT + PRP

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

Group Type: EXPERIMENTAL

ESWT

Intervention Type: DEVICE

Receive ESWT once a week for 4 weeks

PRP

Intervention Type: BIOLOGICAL

Receive PRP injection at week 5

ESWT

Receive ESWT once a week for 4 weeks

Group Type: ACTIVE_COMPARATOR

ESWT

Intervention Type: DEVICE

Receive ESWT once a week for 4 weeks

Interventions

ESWT

Receive ESWT once a week for 4 weeks

Intervention Type: DEVICE

PRP

Receive PRP injection at week 5

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ramathibodi hospital

Ratchathewi, Bangkok, Thailand

Countries

Thailand

Facility Contacts

Prapan Wongrungrote, MD

Role: primary

prapanw197@gmail.com

+66 0810688654

Sukij Laohajaroensombat, MD

Role: backup

sukij.lah@mahidol.ac.th

+66 022011589

Other Identifiers

Pending

Identifier Type: -

Identifier Source: org_study_id