Heel Spur SyndromeORHEELSNCT07546240

Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial

A study testing Standard fractioned dose, Reduced fractioned dose and Reduced fractioned dose & Intensity in people with Heel Spur Syndrome, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Heel Spur Syndrome
What is being tested?: Standard fractioned dose, Reduced fractioned dose and Reduced fractioned dose & Intensity
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 366 participants
Where: 1 sitePoland
Study dates: 23 Mar 2026to 22 Mar 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Patient readiness for follow-up contact.
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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iwona Dębosz-Suwińska contact

+48232789148

iwona.debosz-suwinska@gliwice.nio.gov.pl

Mateusz Gajek contact

+48322788063

mateusz.gajek@gliwice.nio.gov.pl

Poland1 site, 1 recruiting

Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, 44-102
Iwona Debosz-Suwinska, 48 32 278 9148, iwona.debosz-suwinska@gliwice.nio.gov.pl
Iwona Dębosz-Suwińska
Recruiting

Other trials in Poland

About this study

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

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.

Read the 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.

Conditions: Heel Spur Syndrome
Being tested: Standard fractioned dose, Reduced fractioned dose, Reduced fractioned dose & Intensity
Keywords: Heel spur, Plantar fasciitis, Low-dose radiotherapy, Anti-inflammatory radiotherapy
Medical subject headings: Fasciitis, Plantar, Heel Spur

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard fractioned doseRadiation
Total dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week
Reduced fractioned doseRadiation
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.
Reduced fractioned dose & IntensityRadiation
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week

Study groups in NCT07546240
Study group	Role	What they receive
Arm A	Experimental	Polish Standard Dose Receives: Radiation: Standard fractioned dose
Arm B	Experimental	Arm B (Reduced Dose) Receives: Radiation: Reduced fractioned dose
Arm C	Other	(Reduced Dose \& Intensity) Receives: Radiation: Reduced fractioned dose & Intensity

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 3 months after treatment

Secondary outcomes (7)

Assessment of effectiveness in pain relief
Pain relief will be evaluated using:
The Visual Analogue Scale (VAS) and The modified von Pannewitz pain scale.
Measured: 3, 6, 12 and 24 months after treatment
Assessment of functional and gait improvement
Improvement will be measured using the Rowe Score scale.
Measured: Before and 3, 6 and 12 months after treatment
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
Measured: Up to 12 months after 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).
Measured: Throughout the observation period
Patients' reported Quality of Life
Evaluation of the SF-36 questionnaires
Measured: Before and 6, 12 months after the treatment
Evaluation of inflammatory markers
Evaluation of systemic inflammation (morphology, CRP, IL-6, fibrinogen, and TNF-α)
Measured: Before treatment and 1 month after treatment
Assessment of treatment effectiveness
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)
Measured: 3, 6 and 12, 24 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 202622 Mar 2030

First posted22 Apr 2026
Study start23 Mar 2026
Primary completion22 Mar 2030 (estimated)
Study completion22 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Heel Spur SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The trial is designed as a 1:1:1 randomized non-inferiority trial
Masking: None (open label)
Enrolment: 366 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07546240
Sponsor's protocol ID: ORHEELS
Acronym: ORHEELS
Status last verified: Apr 2026
First submitted: 30 Mar 2026
Last updated: 22 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Niewald M, et al. Randomized Multicenter Trial on the Effect of Radiotherapy on Plantar Fasciitis (Painful Heel Spur) using Very Low Doses: Mature Results after 12 Months' Follow-up. International Journal of Radiation Oncology, Biology, Physics. 2025;81(2):S39-S40.
Seegenschmiedt MH, Makoski H-B, Trott KR, Brady LW, editors. Radiotherapy for Non-Malignant Disorders: Contemporary Concepts and Clinical Results. Berlin-Heidelberg-New York: Springer; 2008.
Bulstrode C. Oxford Textbook of Orthopaedics and Trauma. Oxford: Oxford University Press; 2002.
Burkon P, Slavik M, Kazda T, Slampa P, Bobek L, et al. Heel Spur Radiotherapy: Prospective Randomized Clinical Trial. International Journal of Radiation Oncology, Biology, Physics. 2025;123(1):e628-e629
Chow S-C, Shao J, Wang H, Lokhnygina Y. Sample Size Calculations in Clinical Research. Third ed: Chapman and Hall/CRC; 2017
Alvarez B, Montero A, Hernando O, Ciervide R, Garcia J, Lopez M, Garcia-Aranda M, Chen X, Flores I, Sanchez E, Valero J, Prado A, Alonso R, Alonso L, Fernandez-Leton P, Rubio C. Radiotherapy CT-based contouring atlas for non-malignant skeletal and soft tissue disorders: a practical proposal from Spanish experience. Br J Radiol. 2021 Aug 1;94(1124):20200809. doi: 10.1259/bjr.20200809.
PubMed 34282948
Mucke R, Schonekaes K, Micke O, Seegenschmiedt MH, Berning D, Heyder R. Low-dose radiotherapy for painful heel spur. Retrospective study of 117 patients. Strahlenther Onkol. 2003 Nov;179(11):774-8. doi: 10.1007/s00066-003-1126-9.
PubMed 14605748
Rodel F, Frey B, Gaipl U, Keilholz L, Fournier C, Manda K, Schollnberger H, Hildebrandt G, Rodel C. Modulation of inflammatory immune reactions by low-dose ionizing radiation: molecular mechanisms and clinical application. Curr Med Chem. 2012;19(12):1741-50. doi: 10.2174/092986712800099866.
PubMed 22414082
Miszczyk L, Wozniak G, Jochymek B, Trela K, Urban A. [Evaluation of the effectiveness of the calcaneal spurs radiotherapy]. Chir Narzadow Ruchu Ortop Pol. 2003;68(3):191-5. Polish.
PubMed 14564798
Canyilmaz E, Canyilmaz F, Aynaci O, Colak F, Serdar L, Uslu GH, Aynaci O, Yoney A. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):659-66. doi: 10.1016/j.ijrobp.2015.02.009. Epub 2015 Apr 28.
PubMed 25936814

Interested in taking part?

Iwona Dębosz-Suwińska

+48232789148

iwona.debosz-suwinska@gliwice.nio.gov.pl

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Chronic Planter Fascitis
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Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
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Plantar Fasciitis, Chronic

All Heel Spur Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07546240
Acronym / sponsor ID: ORHEELS / ORHEELS
Conditions: Heel Spur Syndrome
Keywords: Heel spur, Plantar fasciitis, Low-dose radiotherapy, Anti-inflammatory radiotherapy
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 366 participants (estimated)
Lead sponsor: Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
Study start: 23 Mar 2026 (actual)
Primary completion: 22 Mar 2030 (estimated)
Study completion: 22 Mar 2030 (estimated)
First posted: 22 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: The trial is designed as a 1:1:1 randomized non-inferiority trial

Arm	Type	Receives
Arm A	Experimental	Radiation: Standard fractioned dosePolish Standard Dose
Arm B	Experimental	Radiation: Reduced fractioned doseArm B (Reduced Dose)
Arm C	Other	Radiation: Reduced fractioned dose & Intensity(Reduced Dose \& Intensity)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

Patient readiness for follow-up contact.
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard fractioned doseTotal dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week	Radiation	Arm A
Reduced fractioned doseTotal dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.	Radiation	Arm B
Reduced fractioned dose & IntensityTotal dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week	Radiation	Arm C

Primary outcome

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

7 secondary outcomes

Assessment of effectiveness in pain relief
Time frame: 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
Reirradiation rate
Time frame: Up to 12 months after treatment
Assessment of treatment safety and tolerability
Time frame: Throughout the observation period
Patients' reported Quality of Life
Time frame: Before and 6, 12 months after the treatment
Evaluation of inflammatory markers
Time frame: Before treatment and 1 month after treatment
Assessment of treatment effectiveness
Time frame: 3, 6 and 12, 24 months after treatment

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
BackgroundNiewald M, et al. Randomized Multicenter Trial on the Effect of Radiotherapy on Plantar Fasciitis (Painful Heel Spur) using Very Low Doses: Mature Results after 12 Months' Follow-up. International Journal of Radiation Oncology, Biology, Physics. 2025;81(2):S39-S40.
BackgroundSeegenschmiedt MH, Makoski H-B, Trott KR, Brady LW, editors. Radiotherapy for Non-Malignant Disorders: Contemporary Concepts and Clinical Results. Berlin-Heidelberg-New York: Springer; 2008.
BackgroundBulstrode C. Oxford Textbook of Orthopaedics and Trauma. Oxford: Oxford University Press; 2002.
BackgroundBurkon P, Slavik M, Kazda T, Slampa P, Bobek L, et al. Heel Spur Radiotherapy: Prospective Randomized Clinical Trial. International Journal of Radiation Oncology, Biology, Physics. 2025;123(1):e628-e629
BackgroundChow S-C, Shao J, Wang H, Lokhnygina Y. Sample Size Calculations in Clinical Research. Third ed: Chapman and Hall/CRC; 2017
Background: PubMed 34282948Alvarez B, Montero A, Hernando O, Ciervide R, Garcia J, Lopez M, Garcia-Aranda M, Chen X, Flores I, Sanchez E, Valero J, Prado A, Alonso R, Alonso L, Fernandez-Leton P, Rubio C. Radiotherapy CT-based contouring atlas for non-malignant skeletal and soft tissue disorders: a practical proposal from Spanish experience. Br J Radiol. 2021 Aug 1;94(1124):20200809. doi: 10.1259/bjr.20200809.
Background: PubMed 14605748Mucke R, Schonekaes K, Micke O, Seegenschmiedt MH, Berning D, Heyder R. Low-dose radiotherapy for painful heel spur. Retrospective study of 117 patients. Strahlenther Onkol. 2003 Nov;179(11):774-8. doi: 10.1007/s00066-003-1126-9.
Background: PubMed 22414082Rodel F, Frey B, Gaipl U, Keilholz L, Fournier C, Manda K, Schollnberger H, Hildebrandt G, Rodel C. Modulation of inflammatory immune reactions by low-dose ionizing radiation: molecular mechanisms and clinical application. Curr Med Chem. 2012;19(12):1741-50. doi: 10.2174/092986712800099866.
Background: PubMed 14564798Miszczyk L, Wozniak G, Jochymek B, Trela K, Urban A. [Evaluation of the effectiveness of the calcaneal spurs radiotherapy]. Chir Narzadow Ruchu Ortop Pol. 2003;68(3):191-5. Polish.
Background: PubMed 25936814Canyilmaz E, Canyilmaz F, Aynaci O, Colak F, Serdar L, Uslu GH, Aynaci O, Yoney A. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):659-66. doi: 10.1016/j.ijrobp.2015.02.009. Epub 2015 Apr 28.
S2e Guideline: Radiotherapy of Benign Diseases. Version 3.0 (19.11.2022). German Society for Radiation Oncology (DEGRO); 2022.Link provided by the sponsor.
European Medicines Agency. Points to consider on switching between superiority and non-inferiority (CPMP/EWP/482/99). London: European Agency for the Evaluation of Medicinal Products; 27 July 2000Link provided by the sponsor.

Related trials for Heel Spur Syndrome

Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
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Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Iwona Dębosz-Suwińska contact

+48232789148

iwona.debosz-suwinska@gliwice.nio.gov.pl

Mateusz Gajek contact

+48322788063

mateusz.gajek@gliwice.nio.gov.pl

Iwona Dębosz-Suwińska principal investigator

Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Iwona Dębosz-Suwińska (+48232789148, iwona.debosz-suwinska@gliwice.nio.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferiority of reduced fraction dose radiotherapy of heel spur (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07546240, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.