Achilles Tendinopathy; the Effect of Shockwave Treatment

Starting soon · Not applicable

Conditions studied: Achilles Tendinopathy (AT), Achilles Tendon, Achilles Tendon Pain

In brief

BACKGROUND Achilles tendinopathy-pain in the Achilles tendon-is a common and often long-lasting condition that limits physical activity and performance, and also affects work capacity and quality of life. The pain is localized either to the mid- portion of the tendon or at its insertion into the calcaneus. Although individually tailored exercise is the first-line treatment, symptoms persist in many patients, highlighting the need for adjunctive therapies. AIM This interdisciplinary and innovative research project aims to evaluate the effect of shockwave therapy in Achilles tendinopathy, both in cases where the pain is located in the mid-portion of the tendon and where it is situated at the tendon's insertion. In addition to assessing effects on pain and function, the study will examine the impact on calcifications, neovascularization (evaluated via Doppler ultrasound), and-uniquely-systemic immunological effects, with a focus on NK cells in the blood, an area that remains largely unexplored. METHOD This is a randomized controlled trial (RCT) with four arms, including 200 patients divided into two groups based on pain location. Half of the participants will receive adjunctive shockwave therapy in six sessions, in addition to exercise following the protocol by Silbernagel et al. The primary outcome measure is self-reported pain assessed using the Numeric Rating Scale (NRS) 0-10 at 12 months. Secondary outcomes include function, assessed through patient-reported outcomes (Victorian Institute of Sport Assessment-Achilles Swedish version, VISA-AS), calf muscle strength and endurance, and jumping ability using a validated test battery. Neovascularization and tendon cross-sectional area will be evaluated using ultrasound/Doppler. In a sub-cohort, immune cell composition in blood will be analyzed using flow cytometry before and after treatment. For patients undergoing surgery, tissue samples will also be collected for cellular composition analysis. SIGNIFICANCE This project has the potential to improve treatment strategies, reduce the need for surgery, and generate entirely new knowledge about the relationship between local tissue pathology and systemic immune responses.

Key facts

Study ID

NCT07685509

Run by

Vastra Gotaland Region

People needed

200

Starts

2026-09-01

Expected to finish

2031-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Women and men over 18 years of age who seek care for load-related pain in the midportion of the Achilles tendon or at the Achilles tendon insertion at a Physiotherapy Clinic in Primary Care, at the Physiotherapy Department at Sahlgrenska University Hospital/Mölndal, or at the Orthopedic Department at Sahlgrenska University Hospital/Mölndal.
• Symptoms must have been present for one month or longer.
• Symptoms may be present in one or both Achilles tendons.

You may not qualify if…

• Unwillingness to receive shockwave therapy.
• Previous shockwave therapy for Achilles tendon pain within the past year.
• Neurological disease, significant cardiac conditions, increased bleeding tendency, treatment with anticoagulant medication, pregnancy, or presence of a tumor in the foot.
• Corticosteroid injection in the foot within the past six months.
• Reduced sensation, acute inflammation, or any wound around the heel.
• Inability to understand or speak Swedish.

Full record on ClinicalTrials.gov

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