[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656529":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":43,"studyPopulation":16,"armGroups":44,"interventions":51,"overallOfficials":16,"centralContacts":56,"locations":62,"responsibleParty":76,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":16,"studyType":96,"phases":97,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":109,"whyStopped":16,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Patient-perceived Global Perceived Effect","This outcome is measured through a Lickert scale. The single question is: \"compared with the start of the trial, how is your \\[condition\\] today?\" Answers from \"completely recovered\" to \"much worse\"","12 months",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Chronic pain",null,{"measure":18,"description":19,"timeFrame":12},"Activity limitations","Roland Morris disability questionnaire, Nordic pain questionnaire. These are validated instruments assessing the influence of the condition on everyday activities. Example \"my \\[condition\\] prevents me from doing household chores\" -agree\u002Fdo not agree. The instrument then results in a score where high scores mean that the condition highly affects daily activities.",{"measure":21,"description":22,"timeFrame":12},"Health-related quality of life","EuorQol-5 dimensions is a validated questionnaire that results in a score between 0 and 1(perfect health).",{"measure":24,"description":25,"timeFrame":12},"Societal costs","Cost related to care consumption, sick-leave, referrals and pharmaceuticals. Self-reported every three months, participants are reporting all care relating to their condition, number of care visits and cost of visits. Travel time is attributed to each care visit. This will also include visits to specialists. They are reporting the number of days they have been off work due to the condition, and all type of medication consumed for their condition.",{"measure":27,"description":28,"timeFrame":12},"Work Ability","Measures the balance between a person's individual resources (such as health, skills, and mental energy) and the actual demands of their job",{"measure":30,"description":31,"timeFrame":12},"sickness absence","The number of days an individual has been off work because of neck and back pain",[33],{"measure":34,"description":35,"timeFrame":12},"Quality of the assessment by manual therapists","A qualitative outcome collected in interviews with healthcare personell and patients",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":16,"timePerspective":16,"maskingInfo":41},"NA","SEQUENTIAL","A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods","HEALTH_SERVICES_RESEARCH",{"masking":42,"maskingDescription":16,"whoMasked":16},"NONE","Many visits to primary healthcare centers (PHCs) concern neck and\u002For back pain (NBP). Evidence-based clinical guidelines are often not considered, and low-value care, including unnecessary imaging, prescription of medications, injections, unnecessary surgery, and sick leave, is instead used, leading to poor patient outcomes and high societal costs. The primary healthcare system is severely pressured, and there is a need to reduce the burden of this common patient group on the physicians. Licensed naprapaths and chiropractors (manual therapist (MT)) have been part of Swedish healthcare for \\>30 years, but their competence is seldom utilized at PHCs. MT as first-contact providers within PHCs may reduce the burden of NBP in the population by improving adherence to evidence-based guidelines, reducing the workload on physicians, minimizing unnecessary healthcare procedures, and reducing expenditure.\n\nPatient reported outcomes include pain, function, work ability and satisfaction, and health economy are based on sickness absence, care consumption, referrals and pharmaceutical use will be compared between groups.\n\nOur hypothesis is that the intervention will lead to symptom improvement and work ability, as well as decrease the risk of sickness absence and low value care (sickness absence, care consumption, referrals and pharmaceutical use) for these patients. Thus, we hypothesize positive consequences for the individual and for society.\n\nAdvanced epidemiological\u002Fstatistical methods address confounding when comparing the groups. Physicians' and patients' experiences, facilitators, and barriers to the implementation of the intervention will also be studied.",[45],{"label":46,"type":47,"description":48,"interventionNames":49},"MT management","EXPERIMENTAL","The intervention in the index group is a triage performed by the licensed manual therapist, MT: take the anamnesis, perform a clinical assessment and examination (including assessment of fear\u002Favoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to evidence-based clinical guidelines, i.e., high-value care. In summary, these guidelines state that patients with no \"Red flags\" (signs of pathology) or \"Yellow flags\" (psychological risk factors such as unrealistic beliefs about their pain, catastrophizing, kinesiophobia) shall self-manage when they are adequately informed about their condition and that they need to continue with their usual activities, such as work, physical activity, and social life. The role of the MT is to triage patients according to the best evidence into three groups: those with little or no risk of persistent pain, those with a moderate risk, and those with a substantial risk of a bad prognosis.",[50],"Other: Manual terapeut management",[52],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":16},"Manual terapeut management","The intervention in the index group is a triage performed by the licensed manual teerapeut: take the anamnesis, perform a clinical and assessment formula examination (fear\u002Favoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to current evidence-based clinical guidelines. The outcome in this intervention arm will be compared to study participants with \"care as usal\" included in sthe study earlier.",[46],[57],{"name":58,"role":59,"phone":60,"phoneExt":16,"email":61},"Iben Axén, PhD","CONTACT","+46 70 44 00 618","iben.axen@ki.se",[63],{"facility":64,"status":16,"city":65,"state":16,"zip":16,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Karolinska Institutet , Stockholm 171 77 Solna","Stockholm","Sweden","SE",{"type":69,"coordinates":70},"Point",[71,72],18.06871,59.32938,{"lat":72,"lon":71},[75],{"name":58,"role":59,"phone":60,"phoneExt":16,"email":61},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Iben Axen","Principal Investigator",[81],{"name":82,"class":6},"Sophiahemmet University","100656529","implementation-of-evidence-based-guidelines-for-assessment-and-counseling-of-patients-with-neck-and-back-pain-in-health-care-centers-100656529",false,"NCT07825116","Implementation of Evidence-based Guidelines for Assessment and Counseling of Patients With Neck and Back Pain in Health Care Centers","ALIGN","Inclusion Criteria:\n\n* Patients 18-70 years, with an appointment with a physician at the primary health care center for a new episode of pain or discomfort in the neck, mid-back or lower back with or without radiating symptoms to the head, arms, or leg\n\nExclusion Criteria:\n\n* Sick-leave for neck- and backpain the preceding three months (at least 50%), having consulted or been treated by licensed healthcare provider for neck- and backpain during the preceding three months, and not mastering the Swedish language","ALL","18 Years","70 Years",{"count":94,"type":95},600,"ESTIMATED","INTERVENTIONAL",[37],"The overall aim is to investigate the health outcomes and consequences, from an individual and a societal perspective, of adding licensed Manual Therapists as first-contact healthcare providers in Primary Health Care centers to triage (not treat) patients seeking care for Neck and Back Pain.\n\nA hybrid, quasi-experimental Target Trial Emulation design employing mixed methods contextualized to participating Primary Health Care centers will be used.\n\nNeck and Back Pain patients with a physician's appointment at a participating Primary Health Care center will be included and followed one year;\n\n* 300 patients with care as usual who see their physician (control group),\n* 300 patients who see a licensed naprapath\u002Fchiropractor for an initial evidence-based assessment\u002Fscreening before the physicians' visit.\n\nPatient outcomes include recovery, function and work ability, as well as health economy are compared between the groups.",[100,101],"Backpain","Neck and Shoulder Pain",[103,104,105,106,107,108],"community health centers","eveidence-based practice","manual therapy","interprofessionalrealtions","low backpain","neckpain","NOT_YET_RECRUITING","2026-09-16",{"date":112,"type":113},"2026-09-17","ACTUAL",{"date":115,"type":95},"2026-11-01",{"date":117,"type":95},"2030-12-31",{"name":5,"class":6},1]