[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624417":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":31,"centralContacts":37,"locations":47,"responsibleParty":63,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":42,"enrollmentInfo":79,"targetDuration":42,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":97,"whyStopped":42,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Leeds","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Arm 1: Active nVNS then Sham","Participants receive active vagus nerve stimulation (intervention)(Days 1-14) followed by 2-week washout (Days 15-28), then subtherapeutic (sham) stimulation (Days 29-42).",[12,13],"Device: Active Vagus Nerve Stimulation","Device: Subtherapeutic Stimulation (Sham Control)",{"label":15,"type":6,"description":16,"interventionNames":17},"Arm 2: Sham then Active nVNS","Participants receive subtherapeutic (sham) stimulation (Days 1-14) followed by 2-week washout (Days 15-28), then active vagus nerve stimulation (intervention)(Days 29-42).",[12,13],[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Active Vagus Nerve Stimulation","Stimulation parameters: The device delivers a proprietary electrical signal consisting of 5,000 Hz sine wave pulses repeated at 25 Hz. Intensity is set at a therapeutic level as advised by the research clinician, sufficient to activate the vagus nerve and produce perceptible muscle contractions in the neck.",[9,15],[25],"gammaCore Sapphire",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Subtherapeutic Stimulation (Sham Control)","Stimulation parameters: The same gammaCore Sapphire device is used, with intensity set at a subtherapeutic level. This produces a perceptible sensation on the skin but does not activate the vagus nerve or cause the muscle contractions associated with therapeutic stimulation.",[9,15],[25],[32,35],{"name":33,"affiliation":5,"role":34},"Manoj Sivan, Prof","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Darren C Greenwood, PhD",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Norah Almutairi","CONTACT","+44 (0)113 392 4396",null,"ml22n2aa@leeds.ac.uk",{"name":33,"role":40,"phone":45,"phoneExt":42,"email":46},"+44 (0)113 392 2564","m.sivan@leeds.ac.uk",[48],{"facility":49,"status":42,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Trust, Chapeltown Road, Leeds, LS7 4SA, United Kingdom","Leeds","West Yorkshire","LS7 4SA","United Kingdom","UK",{"type":56,"coordinates":57},"Point",[58,59],-1.54785,53.79648,{"lat":59,"lon":58},[62],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Darren Greenwood","Senior Lecturer in Biostatistics",[67],{"name":68,"class":6},"The Leeds Teaching Hospitals NHS Trust","100624417","non-invasive-vagus-nerve-stimulation-for-chronic-musculoskeletal-pain-100624417",false,"NCT07409363","Non-invasive Vagus Nerve Stimulation for Chronic Musculoskeletal Pain","A Randomised, Single-blind, Sham-controlled, Crossover Pilot Study Assessing the Effect of Non-invasive Vagus Nerve Stimulation (nVNS) on Autonomic Symptoms and Pain Management in Patients With Chronic Musculoskeletal Pain and Autonomic Dysfunction","RESTORE-MSK","Inclusion Criteria:\n\n1. Individuals diagnosed with musculoskeletal (MSK) conditions and currently experiencing MSK pain lasting for 12 weeks or longer, in line with the ICD-11 criteria for chronic pain.\n2. Identified as having autonomic dysfunction (AD) defined as a score of 17 or more on the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire.\n3. Ability to understand and willingness to sign a written informed consent document.\n4. Stated willingness to comply with all study procedures and be available for the duration of the study (approximately 6 weeks).\n5. Ability to read and understand English sufficiently to complete study questionnaires.\n\nExclusion Criteria:\n\n1. Pregnancy (self-reported; safety of nVNS in pregnancy not established).\n2. Advanced heart disease, including: severe heart failure (NYHA Class III-IV), myocardial infarction within the preceding 6 months, or ongoing investigations for cardiac arrhythmias.\n3. Use of an active implantable medical device, including: cardiac pacemaker, implantable cardioverter-defibrillator (ICD), cochlear implant, hearing aid implant, or any other implanted electronic device.\n4. Concurrent use of another electrical stimulation device, including: transcutaneous electrical nerve stimulation (TENS) unit, muscle stimulator, or any other portable electronic stimulation device.\n5. Inability to provide informed consent.","ALL","18 Years",{"count":80,"type":81},12,"ESTIMATED","INTERVENTIONAL",[84],"NA","Chronic musculoskeletal (MSK) pain affects an estimated 20-33% of the global population and is frequently associated with autonomic nervous system dysfunction, characterised by symptoms such as orthostatic intolerance, palpitations, gastrointestinal dysmotility, and fatigue. Conventional treatments often fail to address this autonomic component, limiting their effectiveness. This pilot study investigates whether non-invasive vagus nerve stimulation (nVNS) using the gammaCore Sapphire device can reduce autonomic symptom severity and improve pain in adults with chronic MSK pain and confirmed autonomic dysfunction.\n\nRESTORE-MSK is a randomised, single-blind, sham-controlled, crossover pilot study. Twelve participants with chronic MSK pain (lasting 12 weeks or longer) and autonomic dysfunction (COMPASS-31 score of 17 or more) will be recruited from musculoskeletal clinics at Chapel Allerton Hospital, Leeds. Participants will be randomly allocated to receive either active nVNS or sham stimulation first, followed by a 2-week washout period, then crossover to the alternative treatment. Each treatment period lasts 14 days, with participants self-administering the device twice daily (morning and evening).\n\nThe primary outcome is change in autonomic symptom severity measured by the Composite Autonomic Symptom Score-31 (COMPASS-31). Secondary outcomes include physiological response to the NASA Lean Test, pain severity and interference (Brief Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L), intervention acceptability, and recruitment feasibility.\n\nThis pilot study aims to establish feasibility and proof of concept for a larger randomised controlled trial investigating nVNS as a non-pharmacological treatment option for chronic MSK pain with autonomic dysfunction.",[87,88,89],"Chronic Musculoskeletal Pain","Autonomic Dysfunction","Dysautonomia",[91,92,93,94,95,96],"Vagus Nerve Stimulation","Non-invasive Neuromodulation","Chronic Pain","Autonomic Nervous System","GammaCore","COMPASS-31","NOT_YET_RECRUITING","2026-05-06",{"date":100,"type":101},"2026-05-11","ACTUAL",{"date":103,"type":81},"2026-05-14",{"date":105,"type":81},"2026-07-31",{"name":5,"class":6},1]