Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy

Summary

Midportion Achilles tendinopathy is a common cause of pain and functional limitation in both athletes and the general population. Progressive tendon loading programs are considered first-line treatment but do not lead to satisfactory outcomes in all patients. Extracorporeal shockwave therapy (ESWT) and platelet-rich plasma (PRP) injections are commonly used interventions for refractory symptoms, yet evidence supporting their combined use is limited particularly in treating Achilles tendon disorders.

This randomized controlled trial will evaluate the effectiveness of a standardized exercise program alone or in combination with PRP injection, ESWT, or both therapies in active adults with midportion Achilles tendinopathy. Participants will be randomized to one of four treatment groups and followed for six months. The primary outcome will assess changes in Achilles tendon symptoms and function using the Victorian Institute of Sport Assessment-Achilles (VISA-A) score. Secondary outcomes will include patient-reported outcomes, physical function testing, ultrasound tendon structure measures, and gait biomechanics.

Conditions

• Achilles Injuries Tendon
• Achilles Tendinopathy (AT)
• Achilles Tendinitis, Left Leg
• Achilles Tendinitis, Right Leg
• Achilles Tendon Pain
• Achilles Tendonitis

Interventions

DEVICE

Platelet Rich Plasma

Participants randomized to PRP will receive a single ultrasound-guided injection of approximately 3 mL of neutrophil-poor platelet-rich plasma derived from autologous blood. Blood will be processed to concentrate platelets and the PRP will be injected adjacent to the Achilles tendon at the site of maximal pain.

DEVICE

Extracorporeal Shockwave Therapy

Participants randomized to ESWT will receive three weekly treatment sessions. Focused shockwave therapy will deliver approximately 2000 shocks with gradual energy escalation, followed by radial shockwave therapy delivering approximately 3000 pulses to the Achilles tendon and 3000 pulses to surrounding musculature.

DEVICE

Sham PRP

A needle will be inserted but no injection will occur around the Achilles tendon

DEVICE

Sham ESWT

Both focused shockwave and radial pressure wave will be in contact with the skin, but the devices will not be active to deliver energy. An audio recording will provide noises similar to the machines operating.

Sponsors & Collaborators

• Storz Medical AG

  collaborator INDUSTRY

• Foundation for Physical Medicine and Rehabilitation

  collaborator OTHER

• Spaulding Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Adam S. Tenforde, MD · Spaulding Rehabiltaition Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2027-11-30

Completion

2028-05-30

FDA Device

Yes

Countries

• United States

Study Locations