Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial

NCT07546240 | Recruiting

• 1 other identifier: ORHEELS
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Heel spur; Plantar fasciitis; Low-dose radiotherapy; Anti-inflammatory radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  3 months after treatment

Secondary Outcomes (7)

• Assessment of effectiveness in pain relief

  3, 6, 12 and 24 months after treatment

• Assessment of functional and gait improvement

  Before and 3, 6 and 12 months after treatment

• Reirradiation rate

  Up to 12 months after treatment

• Assessment of treatment safety and tolerability

  Throughout the observation period

• Patients' reported Quality of Life

  Before and 6, 12 months after the treatment

Study Arms (3)

Arm A

EXPERIMENTAL

Polish Standard Dose

Radiation: Standard fractioned dose

Arm B

EXPERIMENTAL

Arm B (Reduced Dose)

Radiation: Reduced fractioned dose

Arm C

OTHER

(Reduced Dose \& Intensity)

Radiation: Reduced fractioned dose & Intensity

Interventions

Standard fractioned dose RADIATION

Total dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week

Arm A

Reduced fractioned dose RADIATION

Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.

Arm B

Reduced fractioned dose & Intensity RADIATION

Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week

Arm C

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient readiness for follow-up contact.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

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

Gliwice, 44-102, Poland

RECRUITING

Related Publications (10)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Bulstrode C. Oxford Textbook of Orthopaedics and Trauma. Oxford: Oxford University Press; 2002.

  BACKGROUND

• 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

  BACKGROUND

• Chow S-C, Shao J, Wang H, Lokhnygina Y. Sample Size Calculations in Clinical Research. Third ed: Chapman and Hall/CRC; 2017

  BACKGROUND

• 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.

  PMID: 34282948 BACKGROUND

• 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.

  PMID: 14605748 BACKGROUND

• 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.

  PMID: 22414082 BACKGROUND

• 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.

  PMID: 14564798 BACKGROUND

• 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.

  PMID: 25936814 BACKGROUND

Related Links

• S2e Guideline: Radiotherapy of Benign Diseases. Version 3.0 (19.11.2022). German Society for Radiation Oncology (DEGRO); 2022.

MeSH Terms

Conditions

Fasciitis, Plantar; Heel Spur

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Exostoses; Hyperostosis; Bone Diseases

Study Officials

• Iwona Dębosz-Suwińska

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iwona Dębosz-Suwińska

CONTACT

+48232789148; iwona.debosz-suwinska@gliwice.nio.gov.pl

Mateusz Gajek

CONTACT

+48322788063; mateusz.gajek@gliwice.nio.gov.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is designed as a 1:1:1 randomized non-inferiority trial

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 22, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 22, 2030
• Study Completion (Estimated): March 22, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

PL (1)