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

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: painPREMIER cohort
* Other: Control cohort


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| painPREMIER cohort<br> | Device: painPREMIER cohort<br>* Low back pain patients prospectively recruited during the study period and managed with painPREMIER.<br>|
| Control cohort<br> | Other: Control cohort<br>* A matched group of low back pain patients not managed with painPREMIER.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |