Heel SpurNCT06104410
Optimization of Fractionation Schedules of Heel Spur Radiotherapy Prospective Randomized Open-label Trial
A study testing Standard fractioned dose and Experimental single dose in people with Heel Spur, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial summary
About 26 000 patients are treated per year with radiotherapy for non-malignant diseases in the Czech Republic, majority of them with heel spur syndrome which prevalence ranges from 8-10% in the general population. Heel spur represents important socioeconomic as well as health care issue. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heel Spur
- What is being tested?
- Standard fractioned dose and Experimental single dose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 656 53
Tomas Kazda, MD, +420543136902, tomas.kazda@mou.cz
Marek Slavik, MD, +420543131187, slavik@mou.cz
About this study
Official title: Optimization of Fractionation Schedules of Heel Spur Radiotherapy: Monocentric Prospective Randomized Open-label Trial
About 26 000 patients are treated per year with radiotherapy for non-malignant diseases in the Czech Republic, majority of them with heel spur syndrome which prevalence ranges from 8-10% in the general population. Heel spur represents important socioeconomic as well as health care issue. Radiotherapy by orthovoltage X-ray belongs to standard conservative treatment methods with proven antiinflammatory effect. Nevertheless, with increasing incidence of cancer, it may be assumed that availability of radiotherapy service for heel spur patients will be further limited including limitations related to potential pandemic or other emergency situation. This represents upcoming unmet clinical need, where alternative approaches with dramatically abbreviated fractionation schedules are needed in order to keep availability as well as effectivity of heel spur (and other non-malignant disorders) radiotherapy.
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.
Read the detailed description
Purpose/Objective The aim of this study is to optimize the fractionation schedules for radiotherapy in the treatment of heel spurs (HSS, plantar fasciitis) through a prospective randomized open-label trial conducted at Department of Radiation Oncology at Masaryk Memorial Cancer Institute Brno (MMCI). Low-dose external beam radiotherapy (LD-EBRT), known for its anti-inflammatory effect, offers effective pain relief for HSS patients. Currently, the standard LD-EBRT regimen consists of six fractions of 1 Gray (Gy) administered twice weekly, resulting in a total dose of 6 Gy. This study posits the hypothesis that very low total doses of orthovoltage radiotherapy, delivered in a single fraction, may provide pain relief comparable to that achieved with higher doses of fractionated radiotherapy. The primary goal of this research is to determine whether one-day irradiation (a single fraction) is non-inferior to fractionated radiotherapy over a three-month period in terms of pain relief for HSS patients. This study was supported by grant of the Ministry of Health of the Czech Republic AZV NU22-10-00479. All patients signed informed consent.
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
- Heel Spur
- Being tested
- Standard fractioned dose, Experimental single dose
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard fractioned doseRadiation
Total dose of 6 Gy in 2 or 4 single fractions of 1.5 Gy applied twice weekly.
Experimental single doseRadiation
Total dose of 0.5 Gy, 1Gy, 1.5 or 2Gy in 1 single fraction.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (standard fractionated dose): Groups A-B | Active comparator | 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 Receives: Radiation: Standard fractioned dose |
| Arm B (experimental single dose): Groups C-F | Experimental | 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 Receives: Radiation: Experimental single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of single fraction radiotherapy of heel spur
Comparison of 2 arms in 3 months after radiotherapy.Follow-up examinations consist of personal examination,questionnaire survey.Calcaneodynia sum score (100=free of symptoms, 0=very intense symptoms) is calculated by evaluation of Pain symptoms (up to 30 points),Use of appliances (up to 15 points),Professional activities (up to 20 points),Daily/leisure activities (up to 15 points) and Gaint/limp (up to 20 points). Complete pain relief will be assumed if patients will be completely free of pain and regained full ability to walk and function well.Insufficient pain relief will be assumed,if the patient's subjective evaluation (VAS score) of improvement of pain will be less than 80% or if the temporal pattern of clinical response will be unsatisfactory (ie, response will be delayed >3 months or there will be need for second radiotherapy course.Skin toxicity will be evaluated according Common Terminology Criteria for Adverse Events (CTCAE) v5. VAS and SF36 are described in Outcome 4.
Measured: 44 months
Secondary outcomes (5)
Comparison of different single fraction radiotherapy prescription
Comparison of Calcaneodynia sum score at 3 months after radiotherapy between different single fraction radiotherapy prescription. Calcaneodynia sum score (100 = free of symptoms, 0 = very intense symptoms) is calculated by evaluation of Pain symptoms (up to 30 points), Use of appliances (up to 15 points), Professional activities (up to 20 points), Daily/leisure activities (up to 15 points) and Gaint/limp (up to 20 points).
Measured: 44 months
Comparison of the need for reirradiation till 1 year after radiotherapy between fractionated vs. single fraction radiotherapy
To compare the need for reirradiation till 1 year after radiotherapy between fractionated vs.
single fraction radiotherapy. To compare the need of reirradiation till 1 year after radiotherapy between different single fraction radiotherapy prescription. Evaluated simply by keeping score of patients returning for irradiation till 1 year after radiotherapy.
Measured: 44 months
Comparison of quality of life and VAS score at 1.5, 3, 6, 9 and 12 months and Calcaneodynia sum score at 1.5, 6, 9 and 12 months between fractionated vs. single fraction radiotherapy and between different single fractions radiotherapy prescription.
Visual analogue scale (VAS) score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." (0 = no pain, 100 = maximum imaginable pain intensity).SF-36 questionnaire score taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions and single item that provides an indication of perceived change in health. High values indicates good quality of life.
Measured: 44 months
Evaluation of individual (not sum) parts of Calcaneodynia score and individual domains of quality of life
Evaluation of individual (not sum) parts of Calcaneodynia score and individual domains of quality of life as per outcome 1,2 and 4. Calcaneodynia score form is attached in separate file in this project proposal. Sum score (100 = free of symptoms, 0 = very intense symptoms) is calculated by evaluation of Pain symptoms (up to 30 points), Use of appliances (up to 15 points), Professional activities (up to 20 points), Daily/leisure activities (up to 15 points) and Gaint/limp (up to 20 points).
Measured: 44 months
Analysis of the heel spur radiotherapy techniques in Czechia
Conducting a questionnaire survey analyzing the technique of heel spur radiotherapy at individual workplaces performing this type of treatment in Czechia. The questionnaires will be conducted by Masaryk Memorial Cancer Institute and sent to other facilities in Czechia. Results will be evaluated.
Measured: 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Sep 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Heel SpurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial is designed as binary outcome parallel group non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Slampa, prof. MD, Principal investigator, Masaryk Memorial Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104410
- Sponsor's protocol ID
- NU22-10-00479
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31840171Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
PubMed 15152061DeMaio 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.
PubMed 8255812Heyd 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.
PubMed 17225939Barrett SJ, O'Malley R. Plantar fasciitis and other causes of heel pain. Am Fam Physician. 1999 Apr 15;59(8):2200-6.
PubMed 10221305Kriz 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.
PubMed 30197936Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
PubMed 12917892Seegenschmiedt 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.
PubMed 8657925Seegenschmiedt 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.
PubMed 8693404Trott KR. Therapeutic effects of low radiation doses. Strahlenther Onkol. 1994 Jan;170(1):1-12.
PubMed 8303572Bentzen 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.
PubMed 16300846Kern 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.
PubMed 10465365Kern 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.
PubMed 10738086Niewald 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.
PubMed 22836057Ott 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.
PubMed 24668250
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Fractionation Schedules of Heel Spur Radiotherapy: Monocentric Prospective Randomized Open-label Trial
- ClinicalTrials.gov ID
- NCT06104410
- Acronym / sponsor ID
- NU22-10-00479
- Conditions
- Heel Spur
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 26 000 patients are treated per year with radiotherapy for non-malignant diseases in the Czech Republic, majority of them with heel spur syndrome which prevalence ranges from 8-10% in the general population. Heel spur represents important socioeconomic as well as health care issue. Radiotherapy by orthovoltage X-ray belongs to standard conservative treatment methods with proven antiinflammatory effect. Nevertheless, with increasing incidence of cancer, it may be assumed that availability of radiotherapy service for heel spur patients will be further limited including limitations related to potential pandemic or other emergency situation. This represents upcoming unmet clinical need, where alternative approaches with dramatically abbreviated fractionation schedules are needed in order to keep availability as well as effectivity of heel spur (and other non-malignant disorders) radiotherapy.
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.
Detailed description
Purpose/Objective The aim of this study is to optimize the fractionation schedules for radiotherapy in the treatment of heel spurs (HSS, plantar fasciitis) through a prospective randomized open-label trial conducted at Department of Radiation Oncology at Masaryk Memorial Cancer Institute Brno (MMCI). Low-dose external beam radiotherapy (LD-EBRT), known for its anti-inflammatory effect, offers effective pain relief for HSS patients. Currently, the standard LD-EBRT regimen consists of six fractions of 1 Gray (Gy) administered twice weekly, resulting in a total dose of 6 Gy. This study posits the hypothesis that very low total doses of orthovoltage radiotherapy, delivered in a single fraction, may provide pain relief comparable to that achieved with higher doses of fractionated radiotherapy. The primary goal of this research is to determine whether one-day irradiation (a single fraction) is non-inferior to fractionated radiotherapy over a three-month period in terms of pain relief for HSS patients. This study was supported by grant of the Ministry of Health of the Czech Republic AZV NU22-10-00479. All patients signed informed consent.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial is designed as binary outcome parallel group non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Arm A (standard fractionated dose): Groups A-B | Active comparator | Radiation: Standard fractioned doseArm 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 |
| Arm B (experimental single dose): Groups C-F | Experimental | Radiation: Experimental single doseArm 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard fractioned doseTotal dose of 6 Gy in 2 or 4 single fractions of 1.5 Gy applied twice weekly. | Radiation | Arm A (standard fractionated dose): Groups A-B |
| Experimental single doseTotal dose of 0.5 Gy, 1Gy, 1.5 or 2Gy in 1 single fraction. | Radiation | Arm B (experimental single dose): Groups C-F |
Primary outcome
Non-inferiority of single fraction radiotherapy of heel spur
Time frame: 44 months
Comparison of 2 arms in 3 months after radiotherapy.Follow-up examinations consist of personal examination,questionnaire survey.Calcaneodynia sum score (100=free of symptoms, 0=very intense symptoms) is calculated by evaluation of Pain symptoms (up to 30 points),Use of appliances (up to 15 points),Professional activities (up to 20 points),Daily/leisure activities (up to 15 points) and Gaint/limp (up to 20 points). Complete pain relief will be assumed if patients will be completely free of pain and regained full ability to walk and function well.Insufficient pain relief will be assumed,if the patient's subjective evaluation (VAS score) of improvement of pain will be less than 80% or if the temporal pattern of clinical response will be unsatisfactory (ie, response will be delayed >3 months or there will be need for second radiotherapy course.Skin toxicity will be evaluated according Common Terminology Criteria for Adverse Events (CTCAE) v5. VAS and SF36 are described in Outcome 4.
5 secondary outcomes
Comparison of different single fraction radiotherapy prescription
Time frame: 44 months
Comparison of the need for reirradiation till 1 year after radiotherapy between fractionated vs. single fraction radiotherapy
Time frame: 44 months
Comparison of quality of life and VAS score at 1.5, 3, 6, 9 and 12 months and Calcaneodynia sum score at 1.5, 6, 9 and 12 months between fractionated vs. single fraction radiotherapy and between different single fractions radiotherapy prescription.
Time frame: 44 months
Evaluation of individual (not sum) parts of Calcaneodynia score and individual domains of quality of life
Time frame: 44 months
Analysis of the heel spur radiotherapy techniques in Czechia
Time frame: 44 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 31840171Dufek 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.
- Background: PubMed 15152061Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
- Background: PubMed 8255812DeMaio 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.
- Background: PubMed 17225939Heyd 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.
- Background: PubMed 10221305Barrett SJ, O'Malley R. Plantar fasciitis and other causes of heel pain. Am Fam Physician. 1999 Apr 15;59(8):2200-6.
- Background: PubMed 30197936Kriz 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.
- Background: PubMed 12917892Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
- Background: PubMed 8657925Seegenschmiedt 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.
- Background: PubMed 8693404Seegenschmiedt 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.
- Background: PubMed 8303572Trott KR. Therapeutic effects of low radiation doses. Strahlenther Onkol. 1994 Jan;170(1):1-12.
- Background: PubMed 16300846Bentzen 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.
- Background: PubMed 10465365Kern 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Slampa, prof. MD principal investigator
Masaryk Memorial Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard fractioned dose and Experimental single dose in people with Heel Spur, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomas Kazda, MD (+420543136902, tomas.kazda@mou.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of single fraction radiotherapy of heel spur (time frame: 44 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06104410, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.