Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorMaria Sklodowska-Curie National Research Institute of Oncology

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

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

Treatment groups

366 Participants
are divided into 3 treatment groups