Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-03 @ 2:42 PM
Study NCT ID:
NCT00502333
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2007-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-11', 'studyFirstSubmitDate': '2007-07-16', 'studyFirstSubmitQcDate': '2007-07-16', 'lastUpdatePostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability', 'timeFrame': 'Baseline and 3 months'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Baseline and 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['back pain', 'neck pain', 'prognosis', 'catastrophizing', 'coping strategies', 'disability', 'Prognosis for back and neck pain'], 'conditions': ['Back Pain', 'Neck Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the influence of coping strategies and catastrophizing thoughts on disability and the prognosis of back and neck pain in patients treated within the Spanish National Health Service. Patients will be given a visual analog scale (VAS) to rate intensity of pain, the Roland Morris Questionnaire (RMQ) or the Neck Disability Index (NDI) to rate the degree of disability, and the Coping Strategies Questionnaire (CSQ) to rate coping strategies and catastrophizing. Questionnaires will be given at baseline and three months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated within the Spanish National Health Service for subacute or chronic neck or back pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects treated for back or neck pain in the Spanish National Health Service.\n* Able to read and write Spanish.\n* Have signed the informed consent form.\n\nExclusion Criteria:\n\n* Diagnosis or "red flags" for systemic diseases (e.g., cancer, infection).\n* Pain due to fracture or direct trauma to the neck or back.\n* Criteria for referral to surgery (e.g., neurogenic claudication due to spinal stenosis, cauda equina syndrome, serious nerve root compression for more than 6 weeks due to disc herniation).'}, 'identificationModule': {'nctId': 'NCT00502333', 'briefTitle': 'The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kovacs Foundation'}, 'officialTitle': 'The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain Treated Within the Spanish National Health Service', 'orgStudyIdInfo': {'id': 'FK-R-20'}}, 'contactsLocationsModule': {'locations': [{'zip': '07012', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Kovacs Foundation', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'overallOfficials': [{'name': 'Francisco M Kovacs, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kovacs Foundation, Palma de Mallorca, 07012, Spain'}, {'name': 'Mario Gestoso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kovacs Foundation,Palma de Mallorca, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kovacs Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Scientific Department, Kovacs Foundation', 'investigatorFullName': 'Francisco M. Kovacs', 'investigatorAffiliation': 'Kovacs Foundation'}}}}