Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, 44-102, Poland
Location status: Recruiting
Location contact
Iwona Debosz-Suwinska
CONTACT
Iwona Dębosz-Suwińska
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07546240
Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
The aim of this study is to optimize the fractionation schedules for radiotherapy in the treatment of HSS, through a prospective randomized non-inferiority clinical trial conducted at Maria Sklodowska-Curie National Research Institute of Oncology Gliwice Branch, Poland.
Purpose/Objective:
- To evaluate whether the Polish standard dose (6 Gy) achieves non-inferior therapeutic effects compared to the current European Standard Dose (3 Gy).
- To investigate whether daily fractionation is more effective than twice weekly fractionation in maintaining the desired immunomodulatory effect and avoiding a pro-inflammatory "rebound".
- To minimize the risk of stochastic effects (secondary cancers) by halving the cumulative radiation dose.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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
Primary outcomes
-
Non-inferiority of reduced fraction dose radiotherapy of heel spur
Time frame: 3 months after treatment
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
Secondary outcomes
-
Assessment of effectiveness in pain relief
Time frame: 3, 6, 12 and 24 months after treatment
Pain relief will be evaluated using:
The Visual Analogue Scale (VAS) and The modified von Pannewitz pain scale.
-
Assessment of functional and gait improvement
Time frame: Before and 3, 6 and 12 months after treatment
Improvement will be measured using the Rowe Score scale.
-
Reirradiation rate
Time frame: Up to 12 months after treatment
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
Time frame: Throughout the observation period
The skin toxicity evaluated according to the version 5 of the Common Terminology Criteria for Adverse Events (CTCAE).
-
Patients' reported Quality of Life
Time frame: Before and 6, 12 months after the treatment
Evaluation of the SF-36 questionnaires
-
Evaluation of inflammatory markers
Time frame: Before treatment and 1 month after treatment
Evaluation of systemic inflammation (morphology, CRP, IL-6, fibrinogen, and TNF-α)
-
Assessment of treatment effectiveness
Time frame: 3, 6 and 12, 24 months after treatment
The assessment will be conducted in accordance with the definitions provided, depending on the size of the irradiated area and the duration of pain symptoms (less than or more than 6 months)
Study contacts
Contact information is provided by the study sponsor or research team.
Iwona Dębosz-Suwińska
CONTACT
Mateusz Gajek
CONTACT
Sponsors and collaborators
Lead sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Other
Registry information
Official study 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
Acronym: ORHEELS
Important dates
- Study start
- 2026
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Apr 22, 2026
- Registry last updated
- Apr 22, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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