Heel Spur Syndrome
Conditions
Keywords
Heel spur, Plantar fasciitis, Low-dose radiotherapy, Anti-inflammatory radiotherapy
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.
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
RADIATIONStandard fractioned dose
Total dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week
RADIATIONReduced fractioned dose
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.
RADIATIONReduced fractioned dose & Intensity
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The trial is designed as a 1:1:1 randomized non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of reduced fraction dose radiotherapy of heel spur | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of effectiveness in pain relief | 3, 6, 12 and 24 months after treatment | Pain relief will be evaluated using: The Visual Analogue Scale (VAS) and The modified von Pannewitz pain scale. |
| Assessment of functional and gait improvement | Before and 3, 6 and 12 months after treatment | Improvement will be measured using the Rowe Score scale. |
| Reirradiation rate | Up to 12 months after treatment | 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 |
| Assessment of treatment safety and tolerability | Throughout the observation period | The skin toxicity evaluated according to the version 5 of the Common Terminology Criteria for Adverse Events (CTCAE). |
| Patients' reported Quality of Life | Before and 6, 12 months after the treatment | Evaluation of the SF-36 questionnaires |
| Evaluation of inflammatory markers | Before treatment and 1 month after treatment | Evaluation of systemic inflammation (morphology, CRP, IL-6, fibrinogen, and TNF-α) |
| Assessment of treatment effectiveness | 3, 6 and 12, 24 months after treatment | 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) |
Countries
Poland
Contacts
CONTACTIwona Dębosz-Suwińska
CONTACTMateusz Gajek
PRINCIPAL_INVESTIGATORIwona Dębosz-Suwińska
Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Outcome results
None listed