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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Polish Standard Dose |
|
| Arm B | Experimental | Arm B (Reduced Dose) |
|
| Arm C | Other | (Reduced Dose & Intensity) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard fractioned dose | Radiation | Total dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of effectiveness in pain relief | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iwona Dębosz-Suwińska | Contact | +48232789148 | iwona.debosz-suwinska@gliwice.nio.gov.pl | |
| Mateusz Gajek | Contact | +48322788063 | mateusz.gajek@gliwice.nio.gov.pl |
| Name | Affiliation | Role |
|---|---|---|
| Iwona Dębosz-Suwińska | Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch | Recruiting | Gliwice | 44-102 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 34282948 |
| Label | URL |
|---|---|
| S2e Guideline: Radiotherapy of Benign Diseases. Version 3.0 (19.11.2022). German Society for Radiation Oncology (DEGRO); 2022. | View source |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| D036982 | Heel Spur |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
| D005096 | Exostoses |
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The trial is designed as a 1:1:1 randomized non-inferiority trial
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| Reduced fractioned dose | Radiation | Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week. |
|
| Reduced fractioned dose & Intensity | Radiation | Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week |
|
Improvement will be measured using the Rowe Score scale.
| 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 | 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). | Throughout the observation period |
| Patients' reported Quality of Life | Evaluation of the SF-36 questionnaires | Before and 6, 12 months after the treatment |
| Evaluation of inflammatory markers | Evaluation of systemic inflammation (morphology, CRP, IL-6, fibrinogen, and TNF-α) | 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) | 3, 6 and 12, 24 months after treatment |
| 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. |
| 14605748 | 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. |
| 22414082 | 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. |
| 14564798 | 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. |
| 25936814 | 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. |
| 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 2000 | View source |
| D015576 |
| Hyperostosis |
| D001847 | Bone Diseases |