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

NCT07483320 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025P002308
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 Tendon Pain; Achilles Tendonitis; Achilles Tendinitis, Right Leg

Keywords

PRP; platelet rich plasma; extracorporeal shockwave; focus shockwave; radial pressure waves; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Victorian Institute of Sport Assessment-Achilles (VISA-A)

  The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).

  baseline, 8 weeks, 4 months, 6 months

Secondary Outcomes (6)

• PROMIS-29 Patient Reported Outcomes

  Baseline, 8 weeks, 4 months, 6 months

• University of Wisconsin Running Injury and Recovery Index (UWRI)

  baseline, 8 weeks, 4 months, 6 months

• Ultrasound Tendon Cross-Sectional Area

  baseline, 6 months

• Heel Rise Test Endurance

  baseline, 6 months

• Hop Test Pain

  baseline, 6 months

Study Arms (4)

Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave

SHAM COMPARATOR

A sham PRP injection will be performed where the needle breaks the skin but does not fenestrate the tendon. The sham ESWT will include radial pressure waves and focused shockwaves delivered without the device turned on to deliver energy and audio recording. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.

Device: Sham PRP; Device: Sham ESWT

Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave

EXPERIMENTAL

PRP will be delivered around the tendon, sham ESWT will be issued. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.

Device: Platelet Rich Plasma; Device: Sham ESWT

Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP

EXPERIMENTAL

Sham PRP will be delivered. Three sessions of ESWT will be delivered to the Achilles tendon. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.

Device: Extracorporeal Shockwave Therapy; Device: Sham PRP

Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy

EXPERIMENTAL

PRP will be administered followed by three sessions of ESWT. Standard of care exercise program will be prescribed to participants with four stages to be performed during the study.

Device: Platelet Rich Plasma; Device: Extracorporeal Shockwave Therapy

Interventions

Platelet Rich Plasma DEVICE

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.

Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave; Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy

Extracorporeal Shockwave Therapy DEVICE

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.

Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP; Arm 4 - Exercise Therapy + Platelet-Rich Plasma + Extracorporeal Shockwave Therapy

Sham PRP DEVICE

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

Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave; Arm 3 - Exercise Therapy + Extracorporeal Shockwave Therapy (ESWT) + Sham PRP

Sham ESWT DEVICE

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.

Arm 1 - Control Exercise Therapy + Sham PRP + Sham Shockwave; Arm 2 - Exercise Therapy + Platelet-Rich Plasma (PRP) + Sham Shockwave

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years
• Diagnosis of unilateral midportion Achilles tendinopathy
• Symptoms present for more than 3 months
• VISA-A score \<80 at baseline
• Pre-injury physical activity level ≥3 on the Physical Activity Scale
• Ability to participate in rehabilitation program

You may not qualify if:

• Symptoms present for less than 3 months
• Prior PRP injection or ESWT treatment to the Achilles tendon within 3 months
• Other lower extremity musculoskeletal injury affecting function
• Symptomatic arthritis affecting the ankle or foot
• Rheumatologic disease or connective tissue disorder
• Coagulopathy or anticoagulant therapy affecting platelet function
• Neuropathy affecting pain perception
• Known cardiac condition contraindicating treatment
• Poorly controlled diabetes (HbA1c \>9.0)
• Pregnancy

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Storz Medical AG: collaborator
• Foundation for Physical Medicine and Rehabilitation: collaborator

Study Sites (1)

Spaulding Cambridge Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Adam S. Tenforde, MD

  Spaulding Rehabiltaition Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Karnovsky, MD

CONTACT

(862) 216-8050; skarnovsky@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Model Details: Interventional study with option to receive additional treatment at 6 months for those assigned to sham PRP and sham ESWT

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)