[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558080":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":77,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"New York Institute of Technology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Osteopathic Manipulation arm","EXPERIMENTAL","* All subjects receive osteopathic structural exam and screening for somatic dysfunction of the cranium, spine, sacrum, and ribs.\n* The OMT arm will have the following techniques performed for the stated time to total 14 minutes.\n\n  1. Thoracic inlet release: 45 seconds maximum\n  2. Suboccipital release: 1 minute maximum\n  3. Occipito-mastoid suture release: 1 minute maximum\n  4. Venous sinus drainage: 1 minute maximum\n  5. Balanced membranous tension: 1 minute maximum\n  6. Compression of the 4th Ventricle (CV4): 1 minute maximum\n  7. Cervical soft tissue: 1 minute maximum\n  8. Trapezius inhibition: 45 seconds maximum\n  9. Bilateral rib raising: 2 minutes max (1 min per side)\n  10. Sacroiliac gapping: 1 minute maximum\n  11. Sacral rock: 1 minute maximum\n  12. Seated bilateral thoracic and lumbar paraspinal articulation: 2 minutes maximum",[13],"Other: Osteopathic Manipulative Treatment (OMT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Light touch arm","SHAM_COMPARATOR","* All subjects receive osteopathic structural exam and screening for somatic dysfunction of the cranium, spine, sacrum, and ribs..\n* The sham group will follow an established protocol of light systematic touch for the same duration as the OMT group. It consists of contacting a sequence of anatomical areas for 2 minutes each: right ankle, left knee, right hip, diaphragm, right shoulder, neck, and cranium. Total procedure time is 14 minutes.",[19],"Other: Sham Light touch arm",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Osteopathic Manipulative Treatment (OMT)","The active arm will receive osteopathic manipulative treatment which is a hands-on treatment modality use to treat a variety of health concerns.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Sham arm will receive a light touch sham treatment.",[15],[30],{"name":31,"affiliation":5,"role":32},"Sheldon Yao, D.O","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","516-686-3754","syao@nyit.edu",[39],{"facility":40,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"Riland Academic Health Care Center","Old Westbury","New York","11545","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-73.59957,40.78871,{"lat":50,"lon":49},{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100558080","can-a-specific-omt-protocol-influence-patient-pain-and-associated-analgesia-use-for-primary-headache-disorders-100558080",false,"NCT06546462","Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders?","Can a Specific OMT Protocol Influence Patient-reported Pain and Associated Analgesia Use for Primary Headache Disorders?","Inclusion Criteria:\n\n* 18 to 75 years of age\n* takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches).\n* 3 months or greater history of headaches or migraines\n* Patient able to tolerate OMT based on osteopathic physician discretion and with consideration of absolute and relative contraindications to OMT\n\nExclusion Criteria:\n\n* current diagnosis of neoplasm\n* history of headache secondary to trauma or concussion\n* history of brain\u002Fcranial surgery, cerebral vascular events\u002Fdisease (e.g., stroke, Brain arteriovenous malformation (AVM), vertebral artery disease)\n* acute psychiatric diagnosis\n* pregnancy\n* history of substance use disorder","ALL","18 Years","75 Years",{"count":65,"type":66},20,"ESTIMATED","INTERVENTIONAL",[69],"NA","The purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication. Osteopathic manipulative treatment (OMT) has been shown to help headache symptoms. The investigators like to see if regular OMT sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications, migraine medications, and opioids. In this randomized controlled trial, a set sequence of OMT will be compared to light touch sham protocol. Investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts.",[72,73,74,75,76],"Headache Disorders","Headache","Analgesia","Opioid Use","Osteopathy",[78,79,73],"Osteopathic manipulative medicine","Osteopathic manipulative treatment","NOT_YET_RECRUITING","2025-03-12",{"date":83,"type":84},"2025-03-17","ACTUAL",{"date":86,"type":66},"2025-04-08",{"date":88,"type":66},"2025-12-31",{"name":5,"class":6},1]