Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial

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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Non-inferiority of reduced fraction dose radiotherapy of heel spur [Time frame: 3 months after treatment]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Poland · 1 center

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

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. PMID 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. PMID 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. PMID 22414082

Identifiers

NCT: NCT07546240 · ORHEELS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗