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NCT Number: NCT07483320

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Cambridge Hospital

Cambridge, Massachusetts, 02138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Sham PRP

Device

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

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.

Primary outcomes

  1. Victorian Institute of Sport Assessment-Achilles (VISA-A)

    Time frame: baseline, 8 weeks, 4 months, 6 months

    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).

Secondary outcomes

  1. PROMIS-29 Patient Reported Outcomes

    Time frame: Baseline, 8 weeks, 4 months, 6 months

    Change in PROMIS-29 domain scores evaluating physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and social participation.

  2. University of Wisconsin Running Injury and Recovery Index (UWRI)

    Time frame: baseline, 8 weeks, 4 months, 6 months

    Running-specific recovery and functional ability measure for participants who run regularly.

  3. Ultrasound Tendon Cross-Sectional Area

    Time frame: baseline, 6 months

    Changes in Achilles tendon cross-sectional area measured by ultrasound at the site of maximal tendon thickness.

  4. Heel Rise Test Endurance

    Time frame: baseline, 6 months

    Total number of single-leg heel raises performed until fatigue or inability to maintain pace or same height.

  5. Hop Test Pain

    Time frame: baseline, 6 months

    Pain rating following completion of a standardized single-leg hop test of 20 repetitions.

  6. Gait Biomechanics

    Time frame: baseline, 6 months

    Changes in lower extremity biomechanics and symmetry during walking and running assessed using motion capture and instrumented treadmill analysis in those who elect to complete biomechanical assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Sydney Karnovsky, MD

CONTACT

[email protected]

(862) 216-8050

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Foundation for Physical Medicine and Rehabilitation
  • Storz Medical AG

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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