Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial (ORHEELS)

April 16, 2026 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Gliwice, Poland, 44-102
        • Recruiting
        • Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
        • Contact:
        • Principal Investigator:
          • Iwona Dębosz-Suwińska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Polish Standard Dose
Radiation: Standard fractioned dose
Total dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week
Experimental: Arm B
Arm B (Reduced Dose)
Radiation: Reduced fractioned dose
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.
Other: Arm C
(Reduced Dose & Intensity)
Radiation: Reduced fractioned dose & Intensity
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3, 6, 12 and 24 months after treatment
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.
Before and 3, 6 and 12 months after treatment
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
Up to 12 months after 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).
Throughout the observation period
Patients' reported Quality of Life
Time Frame: Before and 6, 12 months after the treatment
Evaluation of the SF-36 questionnaires
Before and 6, 12 months after the treatment
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)
Before treatment and 1 month after treatment
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)
3, 6 and 12, 24 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Investigators

  • Principal Investigator: Iwona Dębosz-Suwińska, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

March 22, 2030

Study Completion (Estimated)

March 22, 2030

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORHEELS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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