Evaluation of the Clinical and Economic Impact of Pfizer's painPRIMER Program in the Treatment of Low Back Pain in a Primary Care Setting

Pfizer1 site in 1 country103 target enrollmentJune 2013

ConditionsLow Back Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Pfizer
Enrollment: 103
Locations: 1
Primary Endpoint: 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
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

July 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Those aged 18 years of age
•Presenting to a HCP with low back pain
•Able to speak, write, and understand both verbal and written English

Exclusion Criteria

•Conditions that may impede the patient's ability to participate in painPRIMER and complete the questionnaires, as per the HCP's discretion
•Patients presenting who have undergone surgery for back pain in the previous 12 months
•Patients with Medicare as their primary insurance

Outcomes

Primary Outcomes

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

Time Frame: 3 month

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

Time Frame: 6 month

Secondary Outcomes

Change from baseline to month 6 in RMDQ total score(3 and 6 months)
Change from baseline to month 3 and 6 in low back pain intensity (LBPI)(3 and 6 months)
Change from baseline to month 3 and 6 daily sleep interference rating scale (DSIRS)(3 and 6 months)
Response as defined as a the proportion of patients with at least 30% and 50% improvement in LBPI at 3 and 6 months(3 and 6 months)
Response as defined as a the proportion of patients with at least 30% and 50% improvement in RMDQ at 3 and 6 months(3 and 6 months)
Quality of Life in the painPRIMER cohort vs control cohort: Change from baseline to month 3 and 6 in the Short- Form.(3 and 6 months)
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(3 and 6 months)
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 >/=(3 and 6 months)
3 on PHQ-4)(3 and 6 months)
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])(3 and 6 months)
productivity/indirect costs: Changes from baseline to month 3 and 6 in Work Productivity and Activity Impairment (WPAI): Specific Health Problem, LBP(3 and 6 months)
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(3 and 6 months)
Patient satisfaction with painPRIMER(3 and 6 months)
Healthcare professional satisfaction with painPRIMER(6 months)