Trials / Not Yet Recruiting

Not Yet RecruitingNCT07483320

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

A Randomized Controlled Trial Evaluating the Influence of Physical Therapy, Shockwave Therapy, Platelet Rich Plasma or Combined Treatment in the Management of Midportion Achilles Tendinopathy

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 100 (estimated)

Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Not accepted

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.

Detailed description

Midportion Achilles tendinopathy (Mid-AT) is characterized by pain, stiffness, and impaired function resulting from a failed tendon healing response. Progressive loading exercise programs such as the Silbernagel protocol represent the current standard treatment and provide meaningful improvement for many individuals. However, approximately 40% of patients continue to experience persistent symptoms despite rehabilitation. Extracorporeal shockwave therapy (ESWT) and platelet-rich plasma (PRP) injections are increasingly used in clinical practice to address refractory symptoms. ESWT is proposed to stimulate tissue healing through mechanotransduction and has demonstrated improved outcomes when combined with exercise therapy in some studies. PRP contains concentrated autologous growth factors that may enhance tendon healing through stimulation of extracellular matrix production, angiogenesis, and collagen synthesis. Despite increasing clinical use, there remains limited evidence evaluating the comparative or combined effects of PRP and ESWT in the treatment of Achilles tendinopathy. Furthermore, few trials have evaluated these therapies within a standardized rehabilitation framework. The purpose of this randomized controlled trial is to evaluate the effectiveness of exercise therapy alone compared with exercise therapy combined with PRP injection, ESWT, or both interventions in individuals with chronic midportion Achilles tendinopathy. Participants will be randomized to one of four treatment groups: exercise with sham procedures (control), exercise plus PRP injection, exercise plus ESWT, or exercise combined with PRP and ESWT. Participants will be followed for six months to evaluate patient-reported outcomes, tendon structure using ultrasound, physical function testing, and gait biomechanics. This study aims to determine whether PRP, ESWT, or the combination of both treatments provide superior functional recovery compared with exercise-based rehabilitation alone.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2026-04-01
Primary completion: 2027-09-30
Completion: 2028-03-30
First posted: 2026-03-19
Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT07483320. Inclusion in this directory is not an endorsement.