[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100330636":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":67,"collaborators":25,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":25,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Bispebjerg Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgery\u002Ffasciotomy","ACTIVE_COMPARATOR","Fasciotomy of the anterior and lateral compartments in the lower legs:\n\nTwo linear longitudinal skin incisions, each approximately 4 cm, are made allowing for excision of the fascia in full length. Sharp dissection to the level of the subcutaneous tissues down to the layer of the overlying fascia is performed, and using a finger or blunt instrument, the subcutaneous tissue is swept away from the fascia, so that an unobstructed cut of the fascia can be performed. The fascia overlying the anterior and lateral compartment is meticulously dissected under direct visualization, the fascia is released approximately as far proximal and distal as the muscle belly is. The perimysium is spared.",[13],"Procedure: Surgery\u002FFasciotomy",{"label":15,"type":10,"description":16,"interventionNames":17},"Physiotherapy","1. Change the running pattern to decrease load on the affected muscles of the lower leg including the eccentric work performed by the tibialis anterior during the rear-foot strike.\n2. Strengthen the major muscles of all lower leg compartments in order address any muscular imbalance\u002Finstability around the ankle joint, and to strengthen the main muscle groups responsible for alignment of the hip and knee.",[18],"Other: Physiotherapy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Surgery\u002FFasciotomy","Open fasciotomy of the anterior and lateral compartment + standard post-operative physiotherapy for 12 weeks",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Intensive physiotherapy for 12 weeks including a change to forefoot\u002Fmidfoot strike during running",[15],[30],{"name":31,"affiliation":32,"role":33},"Simon Doessing, M.D. PhD","Institute of Sports Medicine, Bispebjerg Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Simon Doessing, M.D. PhD.","CONTACT","+4538635042","simon.doessing.01@regionh.dk",[41,56],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Copenhagen","Copehagen","2400","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],12.56553,55.67594,{"lat":52,"lon":51},[55],{"name":31,"role":37,"phone":25,"phoneExt":25,"email":25},{"facility":5,"status":42,"city":43,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},{"type":49,"coordinates":58},[51,52],{"lat":52,"lon":51},[61,64],{"name":31,"role":37,"phone":62,"phoneExt":25,"email":63},"+4535316089","simondoessing@gmail.com",{"name":65,"role":37,"phone":62,"phoneExt":25,"email":66},"Michael Kjaer, M.D. PhD","Michael.Kjaer@regionh.dk",{"type":33,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Simon Doessing, M.D., PhD","Chief Surgeon. M.D. PhD","100330636","physiotherapy-or-fasciotomy-as-treatment-for-chronic-exertional-compartment-syndrome-in-the-lower-leg-100330636",false,"NCT03584815","Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?","Is Physiotherapy or Fasciotomy the Best Treatment Option for Chronic Exertional Compartment Syndrome in the Anterior Compartment of the Lower Leg? A Randomized Controlled Trial.","Inclusion criteria:\n\n* Age between 18 and 50 years\n* Symptoms for more than 3 months\n* Symptoms from both legs. Pain (cramp like, tight, burning or pressure) in the anterior part of the lower leg starting after approximately 10 minutes of exercise\n* Pain worsened with prolonged lower extremity exertion\n* Majority of pain relieved within 30 minutes of rest.\n\nExclusion criteria:\n\n* Previous fasciotomy in the lower leg\n* History of serious trauma involving the lower leg (fracture, muscle\u002Ftendon rupture)\n* ASA (America Association of Anaesthesiologists Classification of Physical Health) \\> 2\n* Clinical symptoms consistent with unilateral anterior CECS or lateral and posterior CECS\n* Clinical symptoms consistent with lumbar spine radiculopathy, periostit\u002Fshin-splint, stress fracture, popliteal artery entrapment syndrome, isolated peroneal nerve entrapment, with isolated muscle fascia herniation.","ALL","18 Years","50 Years",{"count":81,"type":82},72,"ESTIMATED","INTERVENTIONAL",[85],"NA","It is hypothesized that physiotherapy including a change in running landing pattern and surgical fasciotomy are equally good as treatment options for chronic exertional compartment syndrome (CECS) of the anterior compartment of the lower leg.\n\nThe endpoints\u002Foutcomes are:\n\nChange from week 0 (start of study) to week 12 (completion of intervention) in: patient reported outcome measure (PROM) (Exercise induced leg pain Questionnaire (EILP)).\n\nSecondary outcomes are: Visual Analogue Scale (VAS) score after an \"exercise provocation test\": Change in intracompartmental pressure (ICP)Change in muscle compartment compliance. Change in Global Rating of Change Score\u002FScale (GRC). Change in Single Assessment Numeric Evaluation (SANE)\n\nThe study is important because:\n\n1. Results from recent studies suggest that physiotherapy represents a valid alternative to surgery for the treatment of CECS. Surgery is currently standard treatment and a change towards physiotherapy as primary treatment could potentially reduce both complication rates and costs.\n2. Intracompartmental pressure (ICP) is gold standard for diagnosing CECS. However, the association between ICP and symptoms of CECS, both before and after physiotherapeutic and surgical treatment, muscle compartment compliance and intracompartmental perfusion, has not been thoroughly investigated.",[88],"Compartment Syndrome Nontraumatic Lower Leg","2026-03-31",{"date":91,"type":92},"2026-04-06","ACTUAL",{"date":94,"type":92},"2019-05-05",{"date":96,"type":82},"2027-08",{"name":5,"class":6},2]