[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614091":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":58,"studyPopulation":58,"armGroups":62,"interventions":69,"overallOfficials":58,"centralContacts":75,"locations":84,"responsibleParty":98,"collaborators":102,"id":105,"slug":58,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":58,"enrollmentInfo":114,"targetDuration":58,"studyType":117,"phases":118,"briefSummary":119,"conditions":120,"keywords":58,"overallStatus":122,"whyStopped":58,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University Hospital, Linkoeping","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":41,"otherOutcomes":49},[9,13,17,20,23,26,29,32,35,38],{"measure":10,"description":11,"timeFrame":12},"Concentration of HbA1c (mmol\u002Fmol)","This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial.\n\nHbA1c (mmol\u002Fmol), measured from fasting blood samples. Lower values indicate improved glycemic control.","Change from baseline to within 7 days after the fifth massage session (5 weeks).",{"measure":14,"description":15,"timeFrame":16},"Concentration of Copeptin (pmol\u002FL)","Limited efficacy outcome assessing preliminary within-group changes related to physiological stress.\n\nCopeptin measured from fasting serum samples. Lower concentrations indicate reduced stress system activation.","Baseline and within 7 days after final massage (5 weeks).",{"measure":18,"description":19,"timeFrame":12},"Concentration of high-sensitivity C-reactive protein, hs-CRP (mg\u002FL)","Limited efficacy outcome assessing preliminary within-group inflammatory changes.\n\nLower concentrations indicate reduced systemic inflammation",{"measure":21,"description":22,"timeFrame":12},"Concentration of Interleukin-6 (IL-6) (pg\u002FmL)","Limited efficacy outcome assessing preliminary within-group inflammatory changes.\n\nLower IL-6 levels indicate reduced inflammatory activation.",{"measure":24,"description":25,"timeFrame":12},"Mean interstitial glucose (mmol\u002FL) measured by continuous glucose monitoring (CGM)","Limited efficacy outcome assessing preliminary within-group changes in glycemic control.\n\nMean interstitial glucose derived from CGM. Lower values indicate improved glycemic control.",{"measure":27,"description":28,"timeFrame":12},"Glycemic variability (Coefficient of Variation, %), measured by CGM","Limited efficacy outcome assessing preliminary within-group changes in glycemic stability.\n\nLower %CV indicates more stable glucose levels.",{"measure":30,"description":31,"timeFrame":12},"Time in Range (percentage of CGM readings between 3.9-10 mmol\u002FL)","Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation.",{"measure":33,"description":34,"timeFrame":12},"Score on the Perceived Stress Scale-10 (PSS-10)","Limited efficacy outcome assessing preliminary within-group psychological changes.\n\nThe PSS-10 is a 10-item scale ranging 0-40, with higher scores indicating greater perceived stress.",{"measure":36,"description":37,"timeFrame":12},"Score on the Generalized Anxiety Disorder-7 (GAD-7)","Limited efficacy outcome assessing preliminary within-group psychological changes.\n\nThe GAD-7 ranges 0-21, with higher scores indicating more severe anxiety.",{"measure":39,"description":40,"timeFrame":12},"Concentration of fasting plasma glucose (mmol\u002FL)","Limited efficacy outcome assessing preliminary within-group metabolic changes prior to a future randomized trial.\n\nFasting plasma glucose (mmol\u002FL), with lower values indicating improved glycemic control.",[42,46],{"measure":43,"description":44,"timeFrame":45},"Change in Systolic Blood Pressure","This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial.\n\nClinic systolic blood pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile.","Baseline and within 7 days after the final massage session (5 weeks).",{"measure":47,"description":48,"timeFrame":45},"Change in Diastolic Blood Pressure","This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial.\n\nClinic systolic diastolic pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile.",[50],{"measure":51,"description":52,"timeFrame":12},"Exploratory Metabolic and Inflammatory Markers","Additional biomarkers related to stress physiology, inflammation, or short-term glycemic control may be analyzed if relevant and assay-ready samples are available (e.g., additional cytokines, oxidative stress markers, or alternative glycemic indices). These outcomes are exploratory and not required for completion of the study.",{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":58,"timePerspective":58,"maskingInfo":59},"NA","SINGLE_GROUP","All participants receive Swedish massage once weekly for five weeks. Pre-post within-group design to explore biological and psychological effects and study feasibility.","BASIC_SCIENCE",null,{"masking":60,"maskingDescription":61,"whoMasked":58},"NONE","Open-label single-group pilot study; neither participants nor investigators are blinded.",[63],{"label":64,"type":65,"description":66,"interventionNames":67},"Swedish Massage","EXPERIMENTAL","Participants receive Swedish massage once weekly for five consecutive weeks. Each session lasts 45-60 minutes and is delivered by a licensed massage therapist. Techniques include kneading, gliding, and tapping of soft tissues, focusing on the back, shoulders, and neck. The massage is designed to promote relaxation and modulate stress-related biological systems",[68],"Behavioral: Swedish massage",[70],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":58},"BEHAVIORAL","Swedish massage","Participants receive Swedish massage once weekly for five consecutive weeks. Each 45-60-minute session is delivered by a licensed massage therapist using traditional Swedish techniques (kneading, gliding, and tapping) focusing on the back, shoulders, and neck. The intervention aims to promote relaxation and modulate stress-related biological systems. The study uses a single-group pre-post design to explore biological and psychological effects and feasibility.",[64],[76,81],{"name":77,"role":78,"phone":79,"phoneExt":58,"email":80},"Peter Johansson, Professor\u002FRN","CONTACT","460700896548","peter.b.johansson@liu.se",{"name":82,"role":78,"phone":58,"phoneExt":58,"email":83},"Magnus Wijkman, PhD\u002FMD","magnus.wijkman@liu.se",[85],{"facility":86,"status":58,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":58},"Peter Johansson","Norrköping","Linköpings Universitet","601 74","Sweden","SE",{"type":93,"coordinates":94},"Point",[95,96],16.1826,58.59419,{"lat":96,"lon":95},{"type":99,"investigatorFullName":86,"investigatorTitle":100,"investigatorAffiliation":101,"oldNameTitle":58,"oldOrganization":58},"PRINCIPAL_INVESTIGATOR","Professor","Linkoeping University",[103],{"name":101,"class":104},"OTHER_GOV","100614091",false,"NCT07275086","Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes","Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes (TOUCH-D): A Pilot Single-group Feasibility Study Evaluating Biological and Psychological Effects of Swedish Massage in Adults With Type 1 Diabetes.","TOHCD-D","Inclusion Criteria:\n\n* Adults (≥18 years) with type 1 diabetes ≥ 1 year\n* Able to attend two assessment visits at Vrinnevi Hospital\n* Uses CGM or equivalent system\n* Able to communicate in Swedish and provide consent\n\nExclusion Criteria:\n\n* Severe diabetes complications (e.g., advanced neuropathy)\n* Acute psychiatric disorder requiring treatment\n* Contraindications to massage (e.g., thrombosis, fever, infection, recent surgery)","ALL","18 Years",{"count":115,"type":116},20,"ESTIMATED","INTERVENTIONAL",[54],"This pilot study evaluates potential biological and psychological effects of Swedish massage in adults with type 1 diabetes. Massage may influence stress-related mechanisms, such as hypothalamic-pituitary-adrenal (HPA) axis activity and inflammation, which are linked to impaired insulin sensitivity and glycemic control. Twenty participants with type 1 diabetes will receive weekly 45-60-minute Swedish massage sessions for five weeks. Biological outcomes include HbA1c, fasting glucose, copeptin, hs-CRP, IL-6, and TNF-α. Glycemic variability will be assessed using continuous glucose monitoring (CGM). Psychological outcomes include perceived stress (PSS-10) and anxiety (GAD-7). The study aims to explore feasibility, acceptability, and preliminary within-group effects on stress regulation and glycemic balance",[121],"Diabetes Mellitus, Type 1","NOT_YET_RECRUITING","2025-11-28",{"date":125,"type":126},"2025-12-10","ACTUAL",{"date":128,"type":116},"2026-09-01",{"date":130,"type":116},"2027-02-01",{"name":5,"class":6},1]