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.
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.
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).
Parallel
Standard fractioned dose
RadiationTotal dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week
Reduced fractioned dose
RadiationTotal dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.
Reduced fractioned dose & Intensity
RadiationTotal dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week
Non-inferiority of reduced fraction dose radiotherapy of heel spur
The primary endpoint will be evaluated as the difference in treatment success rates between arms A and C and between arms B and C. Success of treatment will be defined as a ≥50% reduction in pain intensity measured using the VAS scale and assessed 3 months after the end of treatment using the Pannewitz-modified pain scale relative to the baseline. Analyses for the two equivalent non-inferiority comparisons (A vs. C and B vs. C) will be performed one-sided at a significance level of α = 0.0125 (after applying the Bonferroni correction), corresponding to 97.5% two-sided confidence intervals, assuming a success rate of 65% for all three treatment regimens and an acceptable non-inferiority margin of δ=0.2, expressed as a risk difference
Assessment of effectiveness in pain relief
Pain relief will be evaluated using: The Visual Analogue Scale (VAS) and The modified von Pannewitz pain scale.
Assessment of functional and gait improvement
Improvement will be measured using the Rowe Score scale.
Reirradiation rate
A comparison of the number of patients requiring reirradiation defined as the proportion of patients requiring a second course of radiotherapy within 12 months of initial treatment
Assessment of treatment safety and tolerability
The skin toxicity evaluated according to the version 5 of the Common Terminology Criteria for Adverse Events (CTCAE).
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