Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-31 @ 3:54 AM
Study NCT ID:
NCT01838057
Status:
TERMINATED
Last Update Posted:
2015-04-16
First Post:
2013-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'whyStopped': 'The study was terminated on 02-Jun-2014 due to slow enrollment. The study was not terminated for reasons of either safety or efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2013-04-15', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Roland Morris Disability Questionnaire: Change from baseline to month 3 in the Roland Morris Disability Questionnaire (RMDQ) total score in the painPRIMER cohort vs control cohort', 'timeFrame': '3 month'}, {'measure': 'Low back pain (LBP) Cost: LBP (specific and related) direct medical costs associated with utilization of healthcare incurred by each study patient from baseline to month 6', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to month 6 in RMDQ total score', 'timeFrame': '3 and 6 months'}, {'measure': 'Change from baseline to month 3 and 6 in low back pain intensity (LBPI)', 'timeFrame': '3 and 6 months'}, {'measure': 'Change from baseline to month 3 and 6 daily sleep interference rating scale (DSIRS)', 'timeFrame': '3 and 6 months'}, {'measure': 'Response as defined as a the proportion of patients with at least 30% and 50% improvement in LBPI at 3 and 6 months', 'timeFrame': '3 and 6 months'}, {'measure': 'Response as defined as a the proportion of patients with at least 30% and 50% improvement in RMDQ at 3 and 6 months', 'timeFrame': '3 and 6 months'}, {'measure': 'Quality of Life in the painPRIMER cohort vs control cohort: Change from baseline to month 3 and 6 in the Short- Form.', 'timeFrame': '3 and 6 months'}, {'measure': 'psychosocial outcomes in the painPRIMER cohort and control cohort: Proportion of patients at risk for depression and/or anxiety (via Patient Health Questionnaire-4 [PHQ-4]) at baseline, 3 and 6 months', 'timeFrame': '3 and 6 months'}, {'measure': 'psychosocial outcomes in the painPRIMER cohort and control cohort: Changes from baseline to month 3 and 6 in patients at risk for depression (PHQ-8) and anxiety (GAD-7), among those receiving the instrument (NOTE: only given to those scoring >/=', 'timeFrame': '3 and 6 months'}, {'measure': '3 on PHQ-4)', 'timeFrame': '3 and 6 months'}, {'measure': 'psychosocial outcomes in the painPRIMER cohort and control cohort: Change from baseline to month 3 and 6 in catastrophizing (Coping Strategies Questionnaire -Catastrophizing [CSQ-CAT])', 'timeFrame': '3 and 6 months'}, {'measure': 'productivity/indirect costs: Changes from baseline to month 3 and 6 in Work Productivity and Activity Impairment (WPAI): Specific Health Problem, LBP', 'timeFrame': '3 and 6 months'}, {'measure': 'Direct cost: Comparison of resource use/direct medical costs, in 6 months pre-enrollment/index date and 6 months post-enrollment/index date via insurance claims data for painPRIMER and control cohorts', 'timeFrame': '3 and 6 months'}, {'measure': 'Patient satisfaction with painPRIMER', 'timeFrame': '3 and 6 months'}, {'measure': 'Healthcare professional satisfaction with painPRIMER', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=X9001010&StudyName=Evaluation%20of%20the%20Clinical%20and%20Economic%20Impact%20of%20%20painPRIMER%20in%20the%20Treatment%20of%20Low%20Back%20Pain%20in%20a%20Primary%20Care%20Setting%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of painPRIMER in a prospective six-month clinical investigation looking at clinical outcomes, health care professional and patient satisfaction, healthcare resource use, productivity and direct and indirect costs. The hypothesis is that early identification of the presence of neuropathic pain and back pain related comorbidities, to direct appropriate pharmacologic and non-pharmacologic treatment, painPRIMER would improve patient outcomes and reduce patient cycling, inappropriate use of imaging and surgery, thereby reducing costs and productivity loss associated with these inefficiencies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with low back pain', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Those aged 18 years of age\n* Presenting to a HCP with low back pain\n* Able to speak, write, and understand both verbal and written English\n\nExclusion Criteria:\n\n* Conditions that may impede the patient's ability to participate in painPRIMER and complete the questionnaires, as per the HCP's discretion\n* Patients presenting who have undergone surgery for back pain in the previous 12 months\n\n * Patients with Medicare as their primary insurance"}, 'identificationModule': {'nctId': 'NCT01838057', 'briefTitle': 'Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "Evaluation of the Clinical and Economic Impact of Pfizer's painPRIMER Program in the Treatment of Low Back Pain in a Primary Care Setting", 'orgStudyIdInfo': {'id': 'X9001010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'painPREMIER cohort', 'interventionNames': ['Device: painPREMIER cohort']}, {'label': 'Control cohort', 'interventionNames': ['Other: Control cohort']}], 'interventions': [{'name': 'painPREMIER cohort', 'type': 'DEVICE', 'description': 'Low back pain patients prospectively recruited during the study period and managed with painPREMIER.', 'armGroupLabels': ['painPREMIER cohort']}, {'name': 'Control cohort', 'type': 'OTHER', 'description': 'A matched group of low back pain patients not managed with painPREMIER.', 'armGroupLabels': ['Control cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30214', 'city': 'Fayetteville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.44873, 'lon': -84.45493}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Piedmont Healthcare System', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}