[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100224198":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":42,"locations":47,"responsibleParty":82,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":31,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":31,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":50,"whyStopped":31,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"BTX-A","ACTIVE_COMPARATOR","Botulinum A toxin is injected each 100 U in both gastrocnemius muscle-bellies and 50 U in the soleus muscle, i.e. a total of 250 U.",[13],"Drug: Botulinum toxin A",{"label":15,"type":10,"description":16,"interventionNames":17},"Cortisone","Depot Medrol is injected at the plantar fascia insertion site at the calcaneus",[18],"Drug: cortisone",{"label":20,"type":21,"description":22,"interventionNames":23},"Saline","PLACEBO_COMPARATOR","Placebo saline is injected in both gastrocnemius muscle-bellies and in the soleus muscle",[24],"Drug: Saline",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Botulinum toxin A","Researchers discovered in the 1950s that injecting overactive muscles with minute quantities of botulinum toxin type-A would result in decreased muscle activity. Botulinum toxin type-A has this effect because it prevents the vesicle where the acetylcholine is stored from binding to the membrane where the neurotransmitter can be released. Botulinum toxin type-A thus blocks the release of acetylcholine by the neuron. This will effectively weaken the muscle for a period of three to four months.\n\nIn addition to its cosmetic applications, Botox is currently used in the treatment of spasms and dystonias, by weakening involved muscles, for the 60-70 day effective period of the drug. The main conditions treated with botulinum toxin are: Cervical dystonia (spasmodic torticollis) (a neuromuscular disorder involving the head and neck), Blepharospasm (excessive blinking) etc..",[9],null,{"type":27,"name":33,"description":31,"armGroupLabels":34,"otherNames":31},"cortisone",[15],{"type":27,"name":20,"description":31,"armGroupLabels":36,"otherNames":31},[20],[38],{"name":39,"affiliation":40,"role":41},"Fabian Krause, PD Dr.","Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland","PRINCIPAL_INVESTIGATOR",[43],{"name":39,"role":44,"phone":45,"phoneExt":31,"email":46},"CONTACT","0041316322220","fabian.krause@insel.ch",[48,67],{"facility":49,"status":50,"city":51,"state":31,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Dep, of Orthopaedic Surgery, Inselspital, University of Berne","RECRUITING","Bern","3010","Switzerland","CH",{"type":56,"coordinates":57},"Point",[58,59],7.44744,46.94809,{"lat":59,"lon":58},[62,63,64],{"name":39,"role":44,"phone":45,"phoneExt":31,"email":46},{"name":39,"role":41,"phone":31,"phoneExt":31,"email":31},{"name":65,"role":66,"phone":31,"phoneExt":31,"email":31},"Maziar Shafighi, PD Dr.","SUB_INVESTIGATOR",{"facility":68,"status":50,"city":69,"state":31,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Department of Orthopaedic Surgery, Kantonsspital Lucerne","Lucerne","6000",{"type":56,"coordinates":72},[73,74],8.30635,47.05048,{"lat":74,"lon":73},[77,81],{"name":78,"role":44,"phone":79,"phoneExt":31,"email":80},"Lukas Iselin, Dr.","004141 205 4807","lukas.iselin@luks.ch",{"name":78,"role":41,"phone":31,"phoneExt":31,"email":31},{"type":83,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[85],{"name":86,"class":6},"Luzerner Kantonsspital","100224198","botulinum-toxin-a-versus-steroids-for-the-treatment-of-chronic-plantar-fasciitis-100224198",false,"NCT02196155","Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis","Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis: a Randomized Controlled Study","Inclusion Criteria:\n\n* Clinical symptoms of a plantar fasciitis\n* Plantar fasciitis in MRI\n* Exclusion of differential diagnoses\n* Symptoms more than 3 months\n* Absolution of 3 months unsuccessful treatment\n* Written informed consent\n\nExclusion Criteria\n\n* Active differential diagnoses\n* Contraindications: pregnancy and breastfeeding, infection at injection sites, allergy against BTX-A\n* Previous injections or surgery for plantar fasciitis\n* Neurological diseases affecting the peripheral nervous system","ALL","18 Years","60 Years",{"count":98,"type":99},54,"ESTIMATED","INTERVENTIONAL",[102],"NA","Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics.\n\nNonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best.\n\nThe investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).\n\nHowever, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed.",[105],"Plantar Fasciitis",[107,28,15,108],"plantar fasciitis","RCT","2024-12-09",{"date":111,"type":112},"2024-12-10","ACTUAL",{"date":114,"type":112},"2016-07",{"date":116,"type":99},"2026-12",{"name":5,"class":6},2]