[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456070":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":48,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum toxin A injection",null,"Patients will receive a total of 3 -three - injections of 75 IU Botulinum Toxin A in the proximal medial gastrocnemius muscle. Treatments will be performed by a specialist in neurology as a Ultra-Sound guided injection into the proximal medial gastrocnemius muscle Injections will be administered at baseline, 3 months and 6 months.",[13],"Drug: Botox",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Botox","75 U in medial gastrocbemius head. x 3",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Elisabet Ellingsen Husebye, MD PhD","CONTACT","+47 91 50 27 70","uxngng@ous-hf.no",{"name":27,"role":23,"phone":24,"phoneExt":10,"email":28},"Martin Riiser, MD Phd candidate","mriise@ous-hf.no",[30],{"facility":31,"status":32,"city":33,"state":33,"zip":10,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Oslo University Hospital, Orthopedic Department Ullevål","RECRUITING","Oslo","Norway","NO",{"type":37,"coordinates":38},"Point",[39,40],10.74609,59.91273,{"lat":40,"lon":39},[43,46],{"name":44,"role":23,"phone":45,"phoneExt":10,"email":25},"Elisabeth Ellingsen Husebye, MD PhD","91 50 27 70",{"name":47,"role":23,"phone":24,"phoneExt":10,"email":28},"Martin Riiser, MD",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Elisabeth Ellingsen Husebye","MD PhD","100456070","treatment-of-gastrocnemius-tightness-and-subsequent-chronic-plantar-fasciitis-with-botulinum-toxin-a-100456070",false,"NCT05218785","Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a","Botulinum Toxin Injection As Treatment for Proximal Medial Gastrocnemius Muscle Tightness with Subsequent Chronic Plantar Fasciitis - a Prospective Clinical Cohort Study","PLATOX","Inclusion criteria:\n\n1. Age 18-75 years.\n2. An isolated gastrocnemius contracture must be verified with the Silfverskiölds test before inclusion.\n3. Diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon.\n4. Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35)\n5. Duration of symptoms must be at least 12 months prior to first BTA injection.\n6. Conventional Physical Therapy must have been tried at least three months without a significant reduction of symptoms in the affected foot.\n\nExclusion criteria:\n\n1. Previously undergone surgery for plantar fasciitis.\n2. Patients with severe talocrural pathology or serious malalignment of foot and ankle\n3. Severely reduced peripheral circulation\n4. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.\n5. Patients with a contraindication\u002Fnon-compliance for MRI examination.\n6. History of allergic reaction\u002Fanaphylactic reaction or other contraindication to botulinum toxin.\n7. Not able to read and\u002For speak a Scandinavian language or English adequately.","ALL","18 Years","75 Years",{"count":64,"type":65},40,"ESTIMATED","OBSERVATIONAL","This prospective clinical cohort study will follow 40 patients who recieve botulinum toxin A treatment for proximal medial gastrocnemius tightness with subsequent Chronic Plantar Fasciitis for two years. Three injections of botulinum toxin (75IU) will be administered with intervals of three months. Participants will be followed at baseline, 3 months, 6 months, 1 year and 2 years with Patient Related Outcome Measures (PROMS) and physical test (Ergotest and ankle dorsiflexion).",[69,70],"Plantar Fascitis","Gastrocnemius Tightness",[72,73,74,75],"proximal medial gastrocnemius recession","gastrocnemius tightness","botox","botulinum toxin a","2025-03-25",{"date":78,"type":79},"2025-03-30","ACTUAL",{"date":81,"type":79},"2022-01-13",{"date":83,"type":65},"2026-01",{"name":5,"class":6},1]