[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592004":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":85,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Duke University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Massage, then talk-based therapy","EXPERIMENTAL","Subjects will be randomized to receive massage for one session, then will receive talk-based therapy after a two week washout period.",[13,14],"Other: Massage","Other: Talk-based therapy",{"label":16,"type":10,"description":17,"interventionNames":18},"Talk-based therapy, then massage","Subjects will be randomized to receive talk-based therapy first, then after a 2 week wash out period will receive a massage threatment",[13,14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Massage","Soft tissue mobilization (STM), also known as massage, is a form of manual therapy. STM consists of many different categories of treatment, but all involve a \"hand's on\" application. During the session, the Dr. Cook will use techniques such as kneading, stretching, and deep tissue manipulation to target the affected areas. The total time of application will be 30 minutes. This \"hands-on\" approach is theorized to reduce muscle tension, improve blood circulation, and promote relaxation. STM stimulates the release of endorphins and serotonin, which are natural painkillers and mood enhancers.",[9,16],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Talk-based therapy","Talk based therapy includes an innovative, evidence-based psychosocial therapy designed to provide rapid and effective pain management for individuals suffering from chronic pain. This single-session, intervention equips patients with essential pain relief skills through a combination of cognitive behavioral therapy (CBT) techniques, mindfulness principles, and pain neuroscience education. The program focuses on teaching patients how to identify and reframe distressing thoughts, practice relaxation techniques, and develop personalized pain management plans.",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Chad E Cook","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Chad E Cook, principal investigator, PT, PHD","CONTACT","19196848905","chad.cook@duke.edu",[40],{"facility":41,"status":24,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"CORE 2200 West Main Street","Durham","North Carolina","27705","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-78.89862,35.99403,{"lat":51,"lon":50},[54,57],{"name":55,"role":36,"phone":56,"phoneExt":24,"email":38},"Chad E Cook, PT PhD","919-684-8905",{"name":58,"role":32,"phone":24,"phoneExt":24,"email":24},"Chad E Cook, professor, PT PhD",{"type":60,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100592004","differences-in-mechanistic-measures-oxytocin-and-cortisol-of-therapeutic-alliance-between-a-talk-based-therapy-and-soft-tissue-mobilization-in-individuals-with-chronic-spinal-pain-100592004",false,"NCT06987786","Differences in Mechanistic Measures (Oxytocin and Cortisol) of Therapeutic Alliance Between A Talk-Based Therapy and Soft-Tissue Mobilization in Individuals With Chronic Spinal Pain","COTHA","Inclusion Criteria include:\n\n* Individuals with chronic spine pain (3 months or greater) (and);\n* who are 18 years of age and older (and)\n* who experience persistent pain of ≥3 on a 10-point scale for the majority of days during the previous 3-months\n\n(The study operationally defines chronic pain using the International Association of the Study of Pain (IASP) pragmatic criteria of pain lasting for 3 months or more that cannot be attributed to another diagnosis or condition).\n\n\\-\n\nExclusion Criteria include:\n\n* Participants with medical conditions that may influence hormone levels during the study (e.g., Cushing's Syndrome, Addison's Disease, etc.) (or),\n* Use of medications (e.g., steroids, antidepressants, or hormonal treatments) that could influence the results (or)\n* Previously diagnosed conditions or factors known to affect cortisol or oxytocin levels, such as chronic stress disorders, hormonal imbalances, or pregnancy.\n\n(After obtaining consent and prior to treatment), the study will screen for potential massage contraindications or other clinical safety considerations and will exclude if:\n\n* participants have infection, skin lesions, (or)\n* Fractures in the region of the massage","ALL","18 Years",{"count":71,"type":72},25,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this randomized cross-over mechanistic trial is to compare pre- and post-level cortisol and oxytocin changes in patients with chronic spine pain who receive either a hand's on (massage) or a hand's off (talk-based) approach. The study plans to address two primary aims.\n\nSpecific Aim One: Directly compare pre- and post-session oxytocin and cortisol levels across two sessions of massage and talk-based therapy. Hypothesis 1: It is expected that in both treatments, oxytocin will increase and cortisol will decrease, demonstrating no significant between-group differences in hormone levels.\n\nSpecific Aim Two: The study plans to compare pre- and post-session oxytocin and cortisol change scores a therapeutic alliance (TA) scale change scores and PROMIS patient-reported outcomes associated with pain, depression, and disability. Hypothesis 2a: It is projected that there will be moderate +\u002F- relationships (R\\>.4) between the therapeutic alliance change score and oxytocin and cortisol levels, suggesting that the hormones moderately reflect the construct associated with TA. Hypothesis 2b: It is expected that there will be weak (R\\>.1) +\u002F-relationships between hormone measures and PROMIS pain\u002Fdisability\u002Fdepression measures, which reflects similar findings to preliminary work.\n\nParticipants will participant in a massage based treatment and a talk-based treatment approach. Participants will also complete patient report outcomes and will receive a total of four salivary swabs.",[78,79,80],"Spine","Low Back Pain","Neck Pain",[82,83,84],"Oxytocin","Cortisol","spinal pain","NOT_YET_RECRUITING","2026-02-18",{"date":88,"type":89},"2026-02-20","ACTUAL",{"date":91,"type":72},"2026-06-01",{"date":93,"type":72},"2026-11-30",{"name":5,"class":6},1]