[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498039":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":46,"responsibleParty":67,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":44,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":44,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":48,"whyStopped":44,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","ACTIVE_COMPARATOR","Botulinum toxin (Botox) injection",[13],"Biological: Botulinum toxin A",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Normal saline injection",[19],"Biological: Normal saline",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Botulinum toxin A","Botulinum injections will be prepared by diluting 100 units of botulinum toxin A with 5.0mL of saline (20.0U\u002FmL). A total of 100 units (5.0mL) of botulinum toxin A will be injected into the tibialis anterior, peroneus longus and peroneus brevis muscles of the affected leg. Under ultrasound guidance, the injectant will be deposited at two sites in each muscle near the motor points.",[9],[27],"Botox",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Normal saline","A total of 5.0mL of normal saline will be injected into the tibialis anterior, peroneus longus and peroneus brevis muscles of the affected leg. Under ultrasound guidance, the injectant will be deposited at two sites in each muscle near the motor points.",[15],[33],"Placebo",[35],{"name":36,"affiliation":37,"role":38},"Victor Lun","University of Calgary Sport Medicine Centre","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Victor Lun, MD","CONTACT","403-220-8518",null,"vmylun@ucalgary.ca",[47],{"facility":37,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Calgary","Alberta","T2N 1N4","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-114.08529,51.05011,{"lat":58,"lon":57},[61,65],{"name":62,"role":42,"phone":63,"phoneExt":44,"email":64},"CECS-Botox Study Coordinator","403-220-8944","cecs.study@ucalgary.ca",{"name":66,"role":38,"phone":44,"phoneExt":44,"email":44},"Victor Lun, MSc, MD",{"type":68,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[70,73],{"name":71,"class":72},"Canadian Academy of Sport and Exercise Medicine (CASEM)","UNKNOWN",{"name":74,"class":72},"Kinesis Medical Centre Inc.","100498039","treatment-of-lower-leg-anterolateral-chronic-exertional-compartment-syndrome-with-intra-muscular-botulinum-injections-100498039",false,"NCT05765071","Treatment of Lower Leg Anterolateral Chronic Exertional Compartment Syndrome With Intra-muscular Botulinum Injections.","Inclusion Criteria:\n\n* Confirmed diagnosis of lower leg anterolateral chronic exertional compartment syndrome (CECS), as measured post-exertional compartment pressure measurements of greater than 30 mmHg for immediate post-exertional compartment pressure, and greater than 12 mmHg at 5 minutes after stopping exercise.\n\nExclusion Criteria:\n\n* Female patients who are pregnant, trying to get pregnant or lactating\n* History of keloidal scarring\n* History of any significant neurologic disease (ie: amyotrophic lateral sclerosis, motor neuropathy, myasthenia gravis, Lambert-Eaton syndrome)","ALL","18 Years","50 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[89],"NA","The goal of this pilot triple-blind randomized clinical trial is to determine the effectiveness of intra-muscular botulism injection for treatment of lower leg anterolateral chronic exertional compartment syndrome (CECS).\n\nPrimary Research Question: What is the effectiveness of intra-muscular botulinum injection, compared to normal saline placebo, for reducing pain related to painful sport activity in patients with lower leg anterolateral chronic exertional compartment syndrome (CECS), over a 24-week period?\n\nSecondary outcomes will measure the time to initial onset and duration of pain during the painful sport activity, characterize the type of pain, foot paraesthesias, self-reported ankle instability, and ankle dorsiflexion and eversion muscle power. The Single Assessment Numeric Evaluation (SANE) score will provide a measure of overall leg function.\n\nAdult patients with a confirmed diagnosis of anterolateral CECS, as determined by post-exertional compartment pressure measurements, will be invited to participate in the study. Using concealed, consecutively-numbered randomization envelopes, participants will be randomly assigned to receive either the botulinum (treatment) or the normal saline (control) injection. Participants will answer a web-based outcome questionnaire at Baseline (prior to receiving the injection) and at 2, 4, 6, 8, 12, 16, 24-weeks follow-up. Participants will be asked to do their painful sport activity the day before completing the questionnaire. Ankle dorsiflexion and eversion muscle power will be manually measured by a physiatrist in clinic at 6, 16 and 24-week follow-up visits.",[92],"Chronic Exertional Compartment Syndrome",[94,95,96],"anterolateral","CECS","lower leg","2026-05-08",{"date":99,"type":100},"2026-05-13","ACTUAL",{"date":102,"type":100},"2025-07-17",{"date":104,"type":86},"2028-06-30",{"name":5,"class":6},1]