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Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial
Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Summary
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.
Official title: Impact of Total Dose and Fractionation on Clinical Outcomes of Low-Dose Radiotherapy for Heel Spur Syndrome: Optimal Radiotherapy - Heel Spur Syndrome (ORHEELS) Randomized Clinical Trial
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
366
Start Date
2026-03-23
Completion Date
2030-03-22
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
Standard fractioned dose
Total dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week
Reduced fractioned dose
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.
Reduced fractioned dose & Intensity
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week
Locations (1)
Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland