[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583892":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":40,"locations":48,"responsibleParty":67,"collaborators":70,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":9,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":102,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"The University of Queensland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SPINEPASS","EXPERIMENTAL","The treatment utilizes anatomy and biomechanics education to inform manual therapy and specific exercises to target areas, such as occipito-atlantal and\u002For atlanto-axial segmental guarded hypermobility. It also addresses general spinal (thoracic, sacroiliac, rib) and adjacent dysfunction (e.g., temporomandibular joint and lower limb) as required. The treatment targets will be individualized based on initial and ongoing evaluation and will include knowledge, skills, and volitional ingredients. SPINEPASS consists of a core set of three daily exercises integrated into daily activities to improve\u002Frestore overall spinal and dural mobility and or stability. It also provides training in the use of specific tools to be used as needed to address symptoms as they occur. Treatment can also include spinal manual therapy and other exercises to enhance the tools, but the emphasis is on self-management.",[13],"Other: SPINEPASS Physical Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Physical Therapy","ACTIVE_COMPARATOR","Participants will be evaluated by the treating physical therapist to address impairments or dysfunction in cervical musculoskeletal structures, the vestibular and or oculomotor system, and the autonomic nervous system (ANS). They will then be prescribed suitable therapeutic exercises for any cervical, vestibular or oculomotor impairments, and they will be provided with advice and education for graded aerobic exercise and or relaxation and breathing exercises (based on patient preference), consistent with the current recommendations for ANS management post mTBI. The cervical therapy for standard Physical Therapy will be based on impairments found but could include cervical and or thoracic manual therapy, exercises to improve segmental range of motion, exercises for cervical and axioscapular neuromotor retraining, and specific cervical related sensorimotor control exercises such as proprioceptive retraining. A home program of exercises tailored for the individual will be provided.",[19],"Other: Standard Physical Therapy",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"SPINEPASS Physical Therapy","SPINEPASS consists of a core set of three daily exercises integrated into daily activities to improve\u002Frestore overall spinal and dural mobility and or stability. It also provides training in the use of specific tools to be used as needed to address symptoms as they occur. Treatment can also include spinal manual therapy and other exercises to enhance the tools, but the emphasis is on self-management.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The cervical therapy for standard Physical Therapy will be based on impairments found but could include cervical and or thoracic manual therapy, exercises to improve segmental range of motion, exercises for cervical and axioscapular neuromotor retraining, and specific cervical related sensorimotor control exercises such as proprioceptive retraining. A home program of exercises tailored for the individual will be provided.",[15],[30,33,36],{"name":31,"affiliation":5,"role":32},"Lucy C Dr Lucy Thomas, PhD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Julia M Dr Julia Treleaven, PhD","University of Queensalnd",{"name":37,"affiliation":38,"role":39},"Amy 0 Dr Amy Bowles, MD","Brooke Army Medical Center","STUDY_DIRECTOR",[41,45],{"name":31,"role":42,"phone":43,"phoneExt":25,"email":44},"CONTACT","+61 336 51644","l.thomas2@uq.edu.au",{"name":46,"role":42,"phone":43,"phoneExt":25,"email":47},"Linda A Mrs Linda Marsh, BPhysio","l.marsh@uq.edu.au",[49],{"facility":50,"status":25,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Brook Army Medical Center","San Antonio","Texas","78234","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-98.49363,29.42412,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":65,"phoneExt":25,"email":66},"Amy o Dr Amy Bowles, MD","210-916-8693","amy.o.bowles.civ@health.mil",{"type":32,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr Lucy Thomas","Principal Investigator",[71,73],{"name":38,"class":72},"FED",{"name":74,"class":72},"United States Department of Defense","100583892","spinepass-spine-self-management-techniques-for-persistent-headache-after-concussion-physical-therapy-targeting-autonomic-and-dura-mater-function-100583892",false,"NCT06882239","SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.","SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function","Inclusion Criteria:\n\n* Persistent Post-traumatic headache (PPTH) duration =or \\> 4 weeks.\n* No self-reported improvement in headache pattern in the past 3 weeks. (Patients will be asked to determine whether the usual pattern of their headaches has changed for the better over the last 3 weeks.\n* Compass-31 score \\> 21 to select patients who have evidence of ANS dysfunction which SPINEPASS aims to address.\n* Headache Impact Test (HIT6) =\\>50 to capture headache-related disability of \"some impact\" or more.\n* Headache worst intensity \\>3\u002F10 on a numerical rating scale (NRS), at least once per week.\n\nExclusion Criteria:\n\n* Contraindications for spinal or graded general exercise.\n\n  * Contraindications to spinal manual therapy at or below C5-6 level\n* Cognitive impairment\u002F language barriers affecting ability to participate.\n* Redeployment\u002Frelocation or retirement planned within the next 6 months to reduce the chances of dropouts to treatment and follow-up.\n* Rating self-confidence to manage (eliminate and or lower) headaches without abortive medication at baseline of 30% or greater.\n* Inability to attend up to 12 in-person treatment sessions for 4 months.\n* Unwilling to limit commencement of other management for PPTH during the trial period.\n* Botox for headache management within the last 8 weeks or during the trial.","ALL","18 Years","65 Years",{"count":86,"type":87},120,"ESTIMATED","INTERVENTIONAL",[90],"NA","This is a prospective randomized controlled trial comparing two different physical therapy approaches to the treatment of posttraumatic headache with autonomic symptoms. AIM 1: To establish the efficacy of SPINEPASS against Standard Physical Therapy to reduce headache disability and impact amongst patients with persistent post-concussion headache. AIM 2: Demonstrate the superiority of SPINEPASS in the efficient self-management of headache. Demonstrate its appropriateness, acceptability, and feasibility and gain patient insights among patients with PPTH compared to standard PT.",[93,94],"Persistent Post-concussive Symptoms","Post Traumatic Headache",[96,97,98,99,100,101],"Persistent post-concussion headache","autonomic","dura","physical therapy","concussion","military","NOT_YET_RECRUITING","2025-03-11",{"date":105,"type":106},"2025-03-18","ACTUAL",{"date":108,"type":87},"2025-05-01",{"date":110,"type":87},"2028-09-30",{"name":5,"class":6},1]