Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT00361556
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2006-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment for Nonspecific Low Back Pain in Primary Care: a Trial on Different Health Education Booklets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-11', 'studyFirstSubmitDate': '2006-08-04', 'studyFirstSubmitQcDate': '2006-08-04', 'lastUpdatePostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of disability at 180 days of follow-up.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Catastrophizing and days on sick leave at 180 days of follow-up.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low back pain', 'disability', 'health education', 'primary care'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '10626311', 'type': 'BACKGROUND', 'citation': 'Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.'}, {'pmid': '11322842', 'type': 'BACKGROUND', 'citation': 'Cherkin DC, Eisenberg D, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, Deyo RA. Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med. 2001 Apr 23;161(8):1081-8. doi: 10.1001/archinte.161.8.1081.'}, {'pmid': '10908942', 'type': 'BACKGROUND', 'citation': 'Hagen EM, Eriksen HR, Ursin H. Does early intervention with a light mobilization program reduce long-term sick leave for low back pain? Spine (Phila Pa 1976). 2000 Aug 1;25(15):1973-6. doi: 10.1097/00007632-200008010-00017.'}], 'seeAlsoLinks': [{'url': 'http://www.reide.org', 'label': 'Spanish Back Pain Research Network site that describes objectives and projects of its members.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to compare the effectiveness on the disability of low back pain patients of The Back Book, The Back Guide, and a control intervention (generic recommendations on general health). Patients are divided into 3 groups:those who receive The Back Book (classic education), those who receive The Back Guide (cognitive behavioral education) and the control group). They are patients who consult a physician at the primary care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low back pain patients,\n* with or without referred or radiated pain;\n* without red flags for systemic disease or criteria for surgery.\n\nExclusion Criteria:\n\n* Inability to read the handout or to fill out the questionnaires;\n* habitually in a prostrate position;\n* diagnosis of inflammatory rheumatologic disease, cancer or fibromyalgia; suspicion of fibromyalgia.'}, 'identificationModule': {'nctId': 'NCT00361556', 'briefTitle': 'Treatment for Nonspecific Low Back Pain in Primary Care: a Trial on Different Health Education Booklets', 'organization': {'class': 'OTHER', 'fullName': 'Kovacs Foundation'}, 'officialTitle': 'Treatment for Nonspecific Low Back Pain in Primary Care With Standardized Health Education Booklets: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'FK-R-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'The Back Book', 'interventionNames': ['Behavioral: The Back Book', 'Behavioral: The Back Guide', 'Behavioral: General health book']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'The Back Guide', 'interventionNames': ['Behavioral: The Back Guide', 'Behavioral: General health book']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'General health book', 'interventionNames': ['Behavioral: General health book']}], 'interventions': [{'name': 'The Back Book', 'type': 'BEHAVIORAL', 'description': 'A book on how to prevent back pain', 'armGroupLabels': ['1']}, {'name': 'The Back Guide', 'type': 'BEHAVIORAL', 'description': 'A guide for the prevention of back pain.', 'armGroupLabels': ['1', '2']}, {'name': 'General health book', 'type': 'BEHAVIORAL', 'description': 'A book on general health', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Throughout Spain', 'country': 'Spain', 'facility': 'Primary care Centers affiliated with the Spanish Back Pain Research Network'}], 'overallOfficials': [{'name': 'Francisco M. Kovacs, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kovacs Foundation, Palma de Mallorca, 07012, Spain'}, {'name': 'Carmen Fernández, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Salut de Valldargent, Palma de Mallorca 07013, Spain'}, {'name': 'Antonio Ruiz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Salud Las Ciudades, Madrid 28903, Spain'}, {'name': 'Carlos Isanta, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Salud de San José, Zaragoza 50013, Spain'}, {'name': 'Violeta González, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Salud Gazteleku, Bilbao 48007, Spain'}, {'name': 'Pablo Panero, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Salud de Órgiva, Órgiva, Granada 18400, Spain'}, {'name': 'Margarita Gómez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Salud Casa del Mar, Palma de Mallorca 07012, Spain'}, {'name': 'Francisco Martínez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Salud de Bembibre, Bembibre, León 24300, Spain'}, {'name': 'Luis González, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Salud Serrería II, Valencia 46022, Spain'}, {'name': 'Sergio Giménez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Salud de Ciudad Jardín, Málaga 29017, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kovacs Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Back Pain Research Network (REIDE)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Carmen Fernández, Centro de Salud de Valldargent', 'investigatorFullName': 'Francisco M. Kovacs', 'investigatorAffiliation': 'Kovacs Foundation'}}}}