Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting
- Conditions
- Low Back Pain
- Interventions
- Device: painPREMIER cohortOther: Control cohort
- Registration Number
- NCT01838057
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 103
- 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
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description painPREMIER cohort painPREMIER cohort - Control cohort Control cohort -
- Primary Outcome Measures
Name Time Method 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 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 6 month
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Fayetteville, Georgia, United States