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

Insertional Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384859
• Other study ID #: Pending
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: April 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insertional Achilles Tendinopathy
• Tendinopathy

Intervention

Device:
• ESWT
Receive ESWT once a week for 4 weeks

Biological:
• PRP
Receive PRP injection at week 5

Locations

Country	Name	City	State
Thailand	Ramathibodi hospital	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Visual Analogue Scale	6 week, 3 months, 6 months and 1 year after treatment
Secondary	VAS-FA	Visual analogue scale foot and ankle	6 week, 3 months, 6 months and 1 year after treatment
Secondary	FFI	Foot functional index	6 week, 3 months, 6 months and 1 year after treatment
Secondary	FAAM	Foot and Ankle Ability Measure	6 week, 3 months, 6 months and 1 year after treatment