[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588456":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":62,"collaborators":40,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":40,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":40,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":40,"overallStatus":48,"whyStopped":40,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Region Stockholm","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BTX-L for myogenous TMD","ACTIVE_COMPARATOR","Patients (n=45) with myogenious TMD will receive treatment with 50 U of Botox®100 U, AbbVie. The drug will be dissolved in 2 millilitres of room-temperate sterile isotonic saline. This gives 5U\u002F0,1 ml solution and each patient will receive a total o 50 U as described in the protocol",[13],"Drug: 5U\u002F0,1 ml Botulinum toxin A",{"label":15,"type":10,"description":16,"interventionNames":17},"BTX-H for myogenous TMD","Patients (n=45) with myogenious TMD will receive treatment with 100 U of Botox®100 U, AbbVie. The drug will be dissolved in 1 millilitre of room-temperate sterile isotonic saline. This gives 10U\u002F0,1 ml solution and each patient will receive a total of 100 U as described in the protocol",[18],"Drug: 10U\u002F0,1 ml Botulinum toxin A",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","5U\u002F0,1 ml Botulinum toxin A","Botox® 100 U (AbbVie) will be dissolved in 2 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 5 U\u002F0.1 mL. Each patient will receive a total dose of 50 U, administered bilaterally into the masseter and temporalis muscles.",[9],[26],"Botox®100 U, AbbVie",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"10U\u002F0,1 ml Botulinum toxin A","Botox® 100 U (AbbVie) will be dissolved in 1 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 10 U\u002F0.1 mL. Each patient will receive a total dose of 100 U, administered bilaterally into the masseter and temporalis muscles.",[15],[26],[33],{"name":34,"affiliation":5,"role":35},"Veronica de Flon","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+ 46 702182623",null,"veronica.deflon@regionstockholm.se",{"name":43,"role":38,"phone":40,"phoneExt":40,"email":44},"Hajer Jasim","hajer.jasim@reigionstockholm.se",[46],{"facility":47,"status":48,"city":49,"state":40,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Eastman institute Folktandvården Region Stockholm","RECRUITING","Stockholm","11324","Sweden","SE",{"type":54,"coordinates":55},"Point",[56,57],18.06871,59.32938,{"lat":57,"lon":56},[60],{"name":34,"role":38,"phone":61,"phoneExt":40,"email":41},"+46702182623",{"type":63,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100588456","phase-3-botulinumtoxin-a-as-a-treatment-for-myalgia-and-myofacial-pain-in-patient-with-temporomandibulardisorders-100588456",false,"NCT06941636","Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders","Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine","Inclusion Criteria:\n\n* Has given a written consent\n* Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according\n* Average pain due to NRS ≥ 3 for more than three months\n* Palpationpain in masseter or temporalis.\n* Eventual treatment for orofacial pain \\> three months ago.\n* Adequate contraceptives and a negative pregnancy test.\n\nPatients will still be included even if they have one or more co-diagnoses\n\n* Discdisplacement with or without reduction\n* Degenerative joint disease\n* Arthralgia\n\nExclusion Criteria:\n\n* Treatment with BTX during the last 12 months\n* Treatment for orofacial pain within the last 3 months.\n* Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)\n* Widespread pain e.g., fibromyalgia\n* Neuropathic pain\n* Neurologic disease (myasthenia gravis)\n* Pain of dental origin\n* Use of muscle relaxants, or aminoglycoside antibiotics\n* Pregnancy or nursing\n* Hypersensitivity to BTX\n* Neuropsychiatric conditions.\n* Difficulties understanding the Swedish language","FEMALE","18 Years","50 Years",{"count":75,"type":76},90,"ESTIMATED","INTERVENTIONAL",[79],"PHASE3","Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent.\n\nThe aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent.",[82],"Temporomandibular Disorder","2025-04-22",{"date":85,"type":86},"2025-04-24","ACTUAL",{"date":88,"type":76},"2025-05-01",{"date":90,"type":76},"2026-12-01",{"name":5,"class":6},1]