[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634942":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":50,"studyPopulation":42,"armGroups":51,"interventions":68,"overallOfficials":82,"centralContacts":87,"locations":96,"responsibleParty":114,"collaborators":42,"id":116,"slug":42,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":42,"enrollmentInfo":125,"targetDuration":42,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":98,"whyStopped":42,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Non-inferiority of reduced fraction dose radiotherapy of heel spur","The primary endpoint will be evaluated as the difference in treatment success rates between arms A and C and between arms B and C.\n\nSuccess 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.\n\nAnalyses 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","3 months after treatment",[14,18,22,26,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Assessment of effectiveness in pain relief","Pain relief will be evaluated using:\n\nThe Visual Analogue Scale (VAS) and The modified von Pannewitz pain scale.","3, 6, 12 and 24 months after treatment",{"measure":19,"description":20,"timeFrame":21},"Assessment of functional and gait improvement","Improvement will be measured using the Rowe Score scale.","Before and 3, 6 and 12 months after treatment",{"measure":23,"description":24,"timeFrame":25},"Reirradiation rate","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","Up to 12 months after treatment",{"measure":27,"description":28,"timeFrame":29},"Assessment of treatment safety and tolerability","The skin toxicity evaluated according to the version 5 of the Common Terminology Criteria for Adverse Events (CTCAE).","Throughout the observation period",{"measure":31,"description":32,"timeFrame":33},"Patients' reported Quality of Life","Evaluation of the SF-36 questionnaires","Before and 6, 12 months after the treatment",{"measure":35,"description":36,"timeFrame":37},"Evaluation of inflammatory markers","Evaluation of systemic inflammation (morphology, CRP, IL-6, fibrinogen, and TNF-α)","Before treatment and 1 month after treatment",{"measure":39,"description":40,"timeFrame":41},"Assessment of treatment effectiveness","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)","3, 6 and 12, 24 months after treatment",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":42,"timePerspective":42,"maskingInfo":48},"RANDOMIZED","PARALLEL","The trial is designed as a 1:1:1 randomized non-inferiority trial","TREATMENT",{"masking":49,"maskingDescription":42,"whoMasked":42},"NONE","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.\n\nPurpose\u002FObjective:\n\n* To evaluate whether the Polish standard dose (6 Gy) achieves non-inferior therapeutic effects compared to the current European Standard Dose (3 Gy).\n* To investigate whether daily fractionation is more effective than twice weekly fractionation in maintaining the desired immunomodulatory effect and avoiding a pro-inflammatory \"rebound\".\n* To minimize the risk of stochastic effects (secondary cancers) by halving the cumulative radiation dose.",[52,58,63],{"label":53,"type":54,"description":55,"interventionNames":56},"Arm A","EXPERIMENTAL","Polish Standard Dose",[57],"Radiation: Standard fractioned dose",{"label":59,"type":54,"description":60,"interventionNames":61},"Arm B","Arm B (Reduced Dose)",[62],"Radiation: Reduced fractioned dose",{"label":64,"type":6,"description":65,"interventionNames":66},"Arm C","(Reduced Dose \\& Intensity)",[67],"Radiation: Reduced fractioned dose & Intensity",[69,74,78],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":42},"RADIATION","Standard fractioned dose","Total dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week",[53],{"type":70,"name":75,"description":76,"armGroupLabels":77,"otherNames":42},"Reduced fractioned dose","Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.",[59],{"type":70,"name":79,"description":80,"armGroupLabels":81,"otherNames":42},"Reduced fractioned dose & Intensity","Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week",[64],[83],{"name":84,"affiliation":85,"role":86},"Iwona Dębosz-Suwińska","Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch","PRINCIPAL_INVESTIGATOR",[88,92],{"name":84,"role":89,"phone":90,"phoneExt":42,"email":91},"CONTACT","+48232789148","iwona.debosz-suwinska@gliwice.nio.gov.pl",{"name":93,"role":89,"phone":94,"phoneExt":42,"email":95},"Mateusz Gajek","+48322788063","mateusz.gajek@gliwice.nio.gov.pl",[97],{"facility":85,"status":98,"city":99,"state":42,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"RECRUITING","Gliwice","44-102","Poland","PL",{"type":104,"coordinates":105},"Point",[106,107],18.67658,50.29761,{"lat":107,"lon":106},[110,113],{"name":111,"role":89,"phone":112,"phoneExt":42,"email":91},"Iwona Debosz-Suwinska","48 32 278 9148",{"name":84,"role":86,"phone":42,"phoneExt":42,"email":42},{"type":115,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100634942",false,"NCT07546240","Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial","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","ORHEELS","Inclusion Criteria:\n\n* Patients aged 40 years or older.\n* Clinically confirmed painful Heel Spur Syndrome (plantar fasciitis) persisting for at least 3 months\n* No effect from previous orthopaedic, physical, or analgesic treatments.\n* General performance status ZUBROD 0-3.\n* Exclusion of other local conditions.\n* Patient readiness for follow-up contact.\n\nExclusion Criteria:\n\n* Prior radiotherapy for heel spur.\n* Local use of corticosteroids within 4 weeks before planned radiotherapy.\n* Previous trauma, surgery to the foot on the same side.\n* Systemic diseases (eg collagen vascular disease).\n* Pregnancy or breastfeeding.\n* Lack of written informed consent","ALL","40 Years",{"count":126,"type":127},366,"ESTIMATED","INTERVENTIONAL",[130],"NA","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\u002Fweek) is not inferior to the treatment with total dose of 3 Gy \u002F fx 0,5 Gy \u002Ffractionated twice weekly. The study is designed to assess the impact of intensity of treatment (daily (5 times \u002F week) versus twice weekly fractionation) on clinical outcomes.",[133],"Heel Spur Syndrome",[135,136,137,138],"Heel spur","Plantar fasciitis","Low-dose radiotherapy","Anti-inflammatory radiotherapy","2026-04-16",{"date":141,"type":142},"2026-04-22","ACTUAL",{"date":144,"type":142},"2026-03-23",{"date":146,"type":127},"2030-03-22",{"name":5,"class":6},1]