Changeflow GovPing Healthcare & Life Sciences ORHEELS Randomized Radiotherapy Trial for Heel ...
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ORHEELS Randomized Radiotherapy Trial for Heel Spur Syndrome

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Summary

The ORHEELS trial (NCT07546240) registered on ClinicalTrials.gov on April 22, 2026, will compare two low-dose radiotherapy fractionation schedules for Heel Spur Syndrome. The study plans to enroll patients with HSS who have failed conservative care, randomizing them to either a Polish standard dose of 6 Gy in 6 daily fractions (5x/week) or a reduced dose of 3 Gy delivered twice weekly. The trial's primary objective is to assess non-inferiority between daily and twice-weekly radiation fractionation regimens, with approximately 30% of HSS patients estimated to have persistent pain despite conservative treatment.

“Low-dose radiation therapy (LDRT) is a well-established European method with proven anti-inflammatory and immunomodulatory effects.”

NIH , verbatim from source
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About this source

GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 696 changes logged to date.

What changed

The ORHEELS randomized clinical trial registration describes a comparative effectiveness study evaluating two low-dose radiotherapy fractionation protocols for Heel Spur Syndrome, a condition affecting approximately 10% of adults with roughly 30% experiencing persistent pain despite conservative treatment. The trial compares a Polish standard protocol (6 Gy total, 1 Gy per fraction, 5 times/week) against an alternative reduced-dose schedule (3 Gy total, 0.5 Gy per fraction, twice weekly).

For clinical investigators and healthcare providers, this trial registration signals ongoing interest in low-dose radiation therapy as an alternative for refractory musculoskeletal conditions. Patients with chronic heel pain who have exhausted conservative options may be candidates for enrollment. The study is registered with NIH via ClinicalTrials.gov, indicating federal oversight of research integrity standards.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial

N/A NCT07546240 Kind: NA Apr 22, 2026

Abstract

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.

Conditions: Heel Spur Syndrome

Interventions: Standard fractioned dose, Reduced fractioned dose, Reduced fractioned dose & Intensity

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07546240

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Radiation therapy research Musculoskeletal treatment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Medical Devices

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