Comparing two low-dose radiotherapy schedules for chronic heel spur (plantar fasciitis)
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
Run by Maria Sklodowska-Curie National Research Institute of Oncology · NCT07546240 · Data updated 2026-11-12
This trial will test whether a standard 6 Gy daily low-dose radiotherapy schedule works as well as a lower 3 Gy twice-weekly schedule for people aged 40 and older with painful heel spurs (plantar fasciitis) that have not improved with other treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 366 (estimated) |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Gliwice) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | March 22, 2030 |
| Study ends | March 22, 2030 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07546240 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 40 or older with clinically confirmed painful heel spur (plantar fasciitis) lasting at least three months, who have not improved with orthopedic, physical, or analgesic treatments and have ZUBROD performance status 0–3.
✕Probably not a fit
Patients who previously had radiotherapy to the heel, recent local corticosteroid injections, prior trauma or surgery on the same foot, systemic collagen vascular disease, pregnancy or breastfeeding, or those unwilling to consent or follow up are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized non-inferiority trial at the Maria Sklodowska-Curie National Research Institute of Oncology (Gliwice) comparing two low-dose radiotherapy fractionation schedules for chronic heel spur syndrome. One arm receives the Polish standard total dose of 6 Gy delivered in daily fractions, and the other receives a reduced total dose of 3 Gy delivered as 0.5 Gy fractions twice weekly. The trial will compare clinical outcomes and symptom control between the schedules while monitoring for signs of pro-inflammatory rebound and other adverse effects. The design aims to determine whether the lower cumulative dose can provide similar symptom relief while reducing long-term stochastic radiation risk.
Why it matters
Potential benefit: If successful, patients could get similar pain relief with roughly half the cumulative radiation, lowering long-term cancer risk and treatment burden.
How similar studies have gone: Low-dose radiotherapy has been used in Europe for plantar fasciitis with reported anti-inflammatory benefits in smaller and non-randomized studies, but randomized comparisons of these specific fractionation schedules are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland Recruiting
Study contacts
- Principal investigator: Iwona Dębosz-Suwińska — Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
- Study coordinator: Iwona Dębosz-Suwińska
- Email: iwona.debosz-suwinska@gliwice.nio.gov.pl
- Phone: +48232789148
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adding sural nerve pulsed radiofrequency to posterior tibial nerve PRF for chronic heel pain
This project tests whether giving pulsed radiofrequency to the sural nerve in addition to the usual posterior tibial nerve PRF reduces pain and improves foot function in adults with chronic plantar heel pain.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.