Optimization of Fractionation Schedules of Heel Spur Radiotherapy Prospective Randomized Open-label Trial

Launched by MASARYK MEMORIAL CANCER INSTITUTE · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a new way to deliver radiotherapy for people suffering from heel spur syndrome, a painful condition affecting the heel. The trial aims to compare two approaches: the standard method, which involves multiple treatment sessions (fractionated radiotherapy), and a quicker method that uses a single treatment session (single fraction radiotherapy). Researchers want to see if the single session is just as effective in reducing heel pain after three months.

To participate in this study, you need to be over 40 years old and have been experiencing heel pain for at least six months due to a heel spur. You'll also need to be in good overall health and willing to stay in touch with the research team for follow-up. If you qualify and decide to join, you can expect to receive either the standard or the one-time treatment, and your progress will be monitored to gather important information about your recovery. This trial is important because it could help improve access to radiotherapy for heel spur patients, especially in situations where healthcare resources are limited.

Gender

ALL

Eligibility criteria

• • All patients referred to medical attention for non-malignant radiotherapy at the Department of Radiation oncology, Masaryk Memorial Cancer Institute (MMCI), will be screened for eligibility, and if all inclusion/exclusion criteria are met, they will be invited to participate in the present study.
• Inclusion Criteria:
• • 1) Patients aged over 40 years who have been diagnosed clinically and radiologically to be suffering from a painful unilateral plantar heel spur for at least six months,
• • 2) indication to heel spur radiotherapy,
• • 3) 40 years or older patient, good performance status (Karnofsky index ≥ 70),
• • 4) exclusion of other local diseases by the orthopaedic surgeon,
• • 5) willingness of the patient to provide telephone or email contact to maintain follow up.
• Exclusion Criteria:
• • 1) Prior radiotherapy of heel spur (even if prior radiotherapy was performed on the contralateral heel spur because of possible bias given patient's expectations and experiences related to previous radiotherapy,
• • 2) corticosteroid local application during last 4 weeks prior to planned radiotherapy,
• • 3) rheumatic or vascular diseases, lymphatic edema of lower limb,
• • 4) former trauma or surgery of ipsilateral foot,
• • 5) any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risk for performance of radiotherapy including claustrophobia or jactation,
• • 6) any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements,
• • 7) pregnancy or breastfeeding,
• • 8) inability or unwillingness of subject to sign written informed consent.