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

Mahidol University

Status and phase: Not yet enrolling; Phase 4

Conditions: Insertional Achilles Tendinopathy

Treatments: Device: ESWT; Biological: PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT06384859

Pending

Details and patient eligibility

About

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

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

ESWT + PRP

Experimental group

Description:

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

Treatment:

Device: ESWT

Biological: PRP

ESWT

Active Comparator group

Description:

Receive ESWT once a week for 4 weeks

Treatment:

Device: ESWT