[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568283":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":41,"locations":51,"responsibleParty":80,"collaborators":83,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":46,"enrollmentInfo":96,"targetDuration":46,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":71,"whyStopped":46,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University of Barcelona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pharmacological control","ACTIVE_COMPARATOR","The subjects in the control group will be treated following a pharmacological approach according to the latest clinical guidelines for patients with chronic low back pain. Thus, the pharmacological options to be considered in each patient will be those included in the first and second analgesic steps of the WHO (preferably without including minor opioids).",[13],"Drug: Usual Care",{"label":15,"type":16,"description":17,"interventionNames":18},"PAINDOC program","EXPERIMENTAL","The PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 7 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over 2 months. It consists of a therapeutic education session (Empowered Relief®) given by a physician from the unit, a pain psychology session given by a psychologist, and 2 pain neuroscience education sessions and 3 therapeutic exercise sessions given by a physiotherapist. This program is already part of the pain unit's routine care practice, so it is considered that the sessions of this program do not represent an additional and specific visit for the patients.",[19],"Behavioral: Multidisciplinary and multimodal intervention",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Multidisciplinary and multimodal intervention","The PAINDOC Program consists in:\n\n* Therapeutic education: The therapeutic education block consists of 2 parts: a 2-hour education session called Empowered Relief® and 2 1-hour pain neuroscience education sessions.\n* Psychotherapy: The psychotherapy part consists of 1 group session of 1 hour, face-to-face and with groups of up to 15 people.\n* Therapeutic exercise: The therapeutic exercise module consists of 3 sessions of 1 hour each, face-to-face, with small groups of between 6 and 10 patients, and given by the physiotherapist of the pain unit.",[15],[15],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Usual Care","The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.",[9],[33],"Pharmacological Control",[35,39],{"name":36,"affiliation":37,"role":38},"Marc Terradas-Monllor, PhD","University of Vic","STUDY_DIRECTOR",{"name":40,"affiliation":5,"role":38},"Christian Dürsteler, PhD",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Anna Dalmau-Roig, MD","CONTACT","+34 639482849",null,"dalmaur@clinic.cat",{"name":36,"role":44,"phone":49,"phoneExt":46,"email":50},"+34 652948632","marc.terradas@uvic.cat",[52,70],{"facility":53,"status":54,"city":55,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Hospital Clínic de Barcelona","NOT_YET_RECRUITING","Barcelona","08006","Spain","ES",{"type":60,"coordinates":61},"Point",[62,63],2.15899,41.38879,{"lat":63,"lon":62},[66,67,68],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},{"name":36,"role":44,"phone":49,"phoneExt":46,"email":50},{"name":43,"role":69,"phone":46,"phoneExt":46,"email":46},"PRINCIPAL_INVESTIGATOR",{"facility":53,"status":71,"city":55,"state":57,"zip":72,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"RECRUITING","08036",{"type":60,"coordinates":74},[62,63],{"lat":63,"lon":62},[77],{"name":78,"role":44,"phone":79,"phoneExt":46,"email":47},"Anna Dalmau-Roig","+34639482849",{"type":69,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Anna Dalmau Roig","Principal Investigator",[84],{"name":85,"class":6},"Hospital Clinic of Barcelona","100568283","effectiveness-of-a-multidisciplinary-treatment-for-patients-with-chronic-low-back-pain-100568283",false,"NCT06679205","Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain","Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain (PAINDOC Protocol): Randomized, Parallel-group, Two-arm, Single-blind Clinical Trial (PAINDOC Project)","PAINDOC","Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Patients with primary chronic low back pain (non-specific chronic low back pain) of axial predominance.\n* Experiencing pain at least 50% of the time over the last 6 months.\n* Average weekly pain intensity equal or greater than 4 out of 10 on a verbal numerical scale.\n* Be agreeable to receiving active, non-pharmacological and non-surgical treatment.\n\nExclusion Criteria:\n\n* Inflammatory low back pain.\n* History of cancer in the last 5 years.\n* Unexplained and unintentional weight loss of 10 Kg or more over the preceding 12-month period.\n* Lack of control of bowel and bladder function (cauda equina).\n* Difficulty in performing the sessions due to severe physical disability.\n* Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).\n* Strong prescription opioid or parenteral medication addiction disorders.\n* Technical-logistical problems (inability to attend treatment sessions or inability to fill out assessment questionnaires).\n* Problems in understanding the content of the sessions (language barrier, severe hearing loss or severe cognitive impairment).\n* Have sought compensation or entered into litigation in the preceding 12-month period.","ALL","18 Years",{"count":97,"type":98},62,"ESTIMATED","INTERVENTIONAL",[101],"NA","PAINDOC is a treatment program that includes 4 disciplines that, separately, have demonstrated their effectiveness in the treatment of chronic low back pain: education in pain neuroscience, therapeutic education (Empowered Relief®), psychotherapy based on cognitive-behavioral therapy and therapeutic exercise.\n\nThe primary objective of the study is to evaluate the effectiveness of the PAINDOC multidisciplinary treatment program in reducing pain intensity and improving quality of life in persons with chronic low back pain referred to the pain unit of the Hospital Clinic of Barcelona, compared to usual care treatment.\n\nAs secondary objectives, the present study aims to evaluate the effect of the PAINDOC program on:\n\n* The reduction of pain-related disability.\n* The reduction of pain catastrophizing.\n* The improvement in perceived social support.\n* The improvement in perceived autonomy (self-efficacy).\n* The reduction of analgesic, anti-inflammatory and adjuvant analgesic medication.\n\nThe main questions it aims to answer are:\n\n* Is the proposed multidisciplinary treatment effective in improving pain-related outcomes?\n* Is the proposed multidisciplinary treatment effective in reducing analgesic medication?\n\nParticipants will receive either usual care (pharmacological control) or the PAINDOC program, which consists of 7 multidisciplinary sessions within 2 months. There will be one therapeutic education session called Empowered Relief®, 2 pain neuroscience education sessions, one pain psychology session and 3 therapeutic education sessions. Besides, participants will be assessed using written questionnaires before treatment, at 3 months and at 6 months.\n\nResearchers will assess the effectiveness of the multidisciplinary treatment group comparing both groups to see if there is any difference in several pain-related outcomes.",[104,105,106],"Chronic Low-back Pain (cLBP)","Chronic Low-back Pain","Back Pain",[108,109,110,111,112,113,114,115],"chronic low-back pain","chronic pain","pain catastrophizing","multidisciplinary treatment","therapeutic exercice","pain neuroscience education","cognitive behavioural therapy","therapeutic education","2025-03-25",{"date":118,"type":119},"2025-03-30","ACTUAL",{"date":121,"type":119},"2025-01-14",{"date":123,"type":98},"2026-03",{"name":5,"class":6},2]