Optimization of Fractionation Schedules of Heel Spur Radiotherapy Prospective Randomized Open-label Trial
NCT ID: NCT06104410
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
430 participants
INTERVENTIONAL
2022-09-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim to presented single institutional prospective randomized open-lable clinical trial is to evaluate low dose radiotherapy delivered in single fraction manner in the treatment of heel spur syndrome.
The project aims to design a randomized trial that compared fractionated and single fraction radiotherapy (non-inferiority). Patients will be randomized into 6 groups according to the total dose, total of 966 patients will be enrolled. The primary objective is to compare Calcaneodynia sum score at 3 months after radiotherapy between fractionated vs. single fraction radiotherapy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis
NCT06969820
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
NCT05406063
A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.
NCT01427010
A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
NCT01208883
Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL Study
NCT02364115
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Material/Methods After completing the enrollment process and filling out the SF-36 questionnaire, as well as the Calcaneodynia score (CS) and visual analogue pain score (VAS) forms, patients (pts) meeting specific inclusion criteria (being over 40 years old, having a diagnosed painful unilateral plantar HSS for at least six months, and being suitable for HSS radiotherapy), and fulfilling the main exclusion criteria (having no prior history of radiotherapy for heel spur, no corticosteroid local application in the four weeks leading up to radiotherapy, no systemic rheumatic or collagen vascular diseases, lymphatic edema of the lower limb, or prior trauma and surgery on the ipsilateral foot), were randomized into six groups based on the total dose of radiotherapy. Patients in these groups received a total dose of 6 Gy in 4 fractions of 1.5 Gy twice weekly (arm A), a total dose of 3 Gy in 2 fractions of 1.5 Gy twice weekly (arm B), a single fraction of 0.5 Gy (arm C), a single fraction of 1.0 Gy (arm D), a single fraction of 1.5 Gy (arm E), and a single fraction of 2 Gy (arm F), respectively. The regimen in arm A (6 Gy in 4 fractions) is commonly used in MMCI and considered as the standard arm. In the event of inadequate pain relief, reirradiation was performed with a total dose of 6 Gy in 4 fractions of 1.5 Gy twice weekly after a waiting period of three months in any of the aforementioned groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A (standard fractionated dose): Groups A-B
Arm A contains of 2 groups. Group A: Total dose of 6 Gy in 4 single fractions of 1.5 Gy applied twice weekly (most commonly used regimen, considered standard arm in this trial) Group B: Total dose of 3 Gy in 2 single fractions of 1.5 Gy applied twice weekly
Standard fractioned dose
Total dose of 6 Gy in 2 or 4 single fractions of 1.5 Gy applied twice weekly.
Arm B (experimental single dose): Groups C-F
Arm B contains of four groups. Group C: Total dose of 0.5 Gy in 1 single fractions of 0.5 Gy Group D: Total dose of 1 Gy in 1 single fractions of 1 Gy Group E: Total dose of 1.5 Gy in 1 single fractions of 1.5 Gy Group F: Total dose of 2 Gy in 1 single fractions of 2 Gy
Experimental single dose
Total dose of 0.5 Gy, 1Gy, 1.5 or 2Gy in 1 single fraction.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard fractioned dose
Total dose of 6 Gy in 2 or 4 single fractions of 1.5 Gy applied twice weekly.
Experimental single dose
Total dose of 0.5 Gy, 1Gy, 1.5 or 2Gy in 1 single fraction.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Masaryk Memorial Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pavel Slampa, prof. MD
Role: PRINCIPAL_INVESTIGATOR
Masaryk Memorial Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Masaryk Memorial Cancer Institute
Brno, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Dufek V, Zackova H, Kotik L, Horakova I. RESULTS OF CZECH NATIONAL STUDY OF RADIATION EXPOSURE FROM RADIOTHERAPY OF NON-MALIGNANT DISEASES, IN PARTICULAR OF HEEL SPURS. Radiat Prot Dosimetry. 2019 Dec 31;186(2-3):386-390. doi: 10.1093/rpd/ncz237.
Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
DeMaio M, Paine R, Mangine RE, Drez D Jr. Plantar fasciitis. Orthopedics. 1993 Oct;16(10):1153-63. doi: 10.3928/0147-7447-19931001-13. No abstract available.
Heyd R, Tselis N, Ackermann H, Roddiger SJ, Zamboglou N. Radiation therapy for painful heel spurs: results of a prospective randomized study. Strahlenther Onkol. 2007 Jan;183(1):3-9. doi: 10.1007/s00066-007-1589-1.
Barrett SJ, O'Malley R. Plantar fasciitis and other causes of heel pain. Am Fam Physician. 1999 Apr 15;59(8):2200-6.
Kriz J, Seegenschmiedt HM, Bartels A, Micke O, Muecke R, Schaefer U, Haverkamp U, Eich HT. Updated strategies in the treatment of benign diseases-a patterns of care study of the german cooperative group on benign diseases. Adv Radiat Oncol. 2018 Feb 26;3(3):240-244. doi: 10.1016/j.adro.2018.02.008. eCollection 2018 Jul-Sep.
Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
Seegenschmiedt MH, Keilholz L, Katalinic A, Stecken A, Sauer R. Heel spur: radiation therapy for refractory pain--results with three treatment concepts. Radiology. 1996 Jul;200(1):271-6. doi: 10.1148/radiology.200.1.8657925.
Seegenschmiedt MH, Keilholz L, Stecken A, Katalinic A, Sauer R. [Radiotherapy of plantar heel spurs: indications, technique, clinical results at different dose concepts]. Strahlenther Onkol. 1996 Jul;172(7):376-83. German.
Trott KR. Therapeutic effects of low radiation doses. Strahlenther Onkol. 1994 Jan;170(1):1-12.
Bentzen SM. Radiation therapy: intensity modulated, image guided, biologically optimized and evidence based. Radiother Oncol. 2005 Dec;77(3):227-30. doi: 10.1016/j.radonc.2005.11.001. Epub 2005 Nov 21. No abstract available.
Kern P, Keilholz L, Forster C, Seegenschmiedt MH, Sauer R, Herrmann M. In vitro apoptosis in peripheral blood mononuclear cells induced by low-dose radiotherapy displays a discontinuous dose-dependence. Int J Radiat Biol. 1999 Aug;75(8):995-1003. doi: 10.1080/095530099139755.
Kern PM, Keilholz L, Forster C, Hallmann R, Herrmann M, Seegenschmiedt MH. Low-dose radiotherapy selectively reduces adhesion of peripheral blood mononuclear cells to endothelium in vitro. Radiother Oncol. 2000 Mar;54(3):273-82. doi: 10.1016/s0167-8140(00)00141-9.
Niewald M, Seegenschmiedt MH, Micke O, Graeber S, Muecke R, Schaefer V, Scheid C, Fleckenstein J, Licht N, Ruebe C; German Cooperative Group on Radiotherapy for Benign Diseases (GCGBD) of the German Society for Radiation Oncology (DEGRO). Randomized, multicenter trial on the effect of radiation therapy on plantar fasciitis (painful heel spur) comparing a standard dose with a very low dose: mature results after 12 months' follow-up. Int J Radiat Oncol Biol Phys. 2012 Nov 15;84(4):e455-62. doi: 10.1016/j.ijrobp.2012.06.022. Epub 2012 Jul 25.
Ott OJ, Jeremias C, Gaipl US, Frey B, Schmidt M, Fietkau R. Radiotherapy for benign calcaneodynia: long-term results of the Erlangen Dose Optimization (EDO) trial. Strahlenther Onkol. 2014 Jul;190(7):671-5. doi: 10.1007/s00066-014-0618-0. Epub 2014 Mar 26.
Rowe CR, Sakellarides HT, Freeman PA, Sorbie C. Fractures of the Os Calcis: A Long-Term Follow-up Study of 146 Patients. JAMA. 1963;184(12):920-923. doi:10.1001/jama.1963.03700250056007
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NU22-10-00479
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.