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Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial

RecruitingNAAges 40 Years - anyAllMaria Sklodowska-Curie National Research Institut…
NCT07546240 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Heel Spur Syndrome (HSS), is a pathology characterized by chronic inflammation and degenerative changes that affect approximately 10% of adults. Although many patients respond to conservative care, about 30% experience persistent pain. Low-dose radiation therapy (LDRT) is a well-established European method with proven anti-inflammatory and immunomodulatory effects. The ORHEELS trial aims to assess whether a Polish standard dose of 6 Gy in 6 daily fractions (fx)(5 times/week) is not inferior to the treatment with total dose of 3 Gy / fx 0,5 Gy /fractionated twice weekly. The study is designed to assess the impact of intensity of treatment (daily (5 times / week) versus twice weekly fractionation) on clinical outcomes.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 40 years or older. * Clinically confirmed painful Heel Spur Syndrome (plantar fasciitis) persisting for at least 3 months * No effect from previous orthopaedic, physical, or analgesic treatments. * General performance status ZUBROD 0-3. * Exclusion of other local conditions. * Patient readiness for follow-up contact. Exclusion Criteria: * Prior radiotherapy for heel spur. * Local use of corticosteroids within 4 weeks before planned radiotherapy. * Previous trauma, surgery to the foot on the same side. * Systemic diseases (eg collagen vascular disease). * Pregnancy or breastfeeding. * Lack of written informed consent
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What it tests

  • Standard fractioned dose
  • Reduced fractioned dose
  • Reduced fractioned dose & Intensity
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Where

1 site
Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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