Low Back Pain
Conditions
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.
Interventions
DEVICEpainPREMIER cohort
Low back pain patients prospectively recruited during the study period and managed with painPREMIER.
OTHERControl cohort
A matched group of low back pain patients not managed with painPREMIER.
Sponsors
Piedmont Healthcare System
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline to month 6 in RMDQ total score | 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 |
| 3 on PHQ-4) | 3 and 6 months |
| Change from baseline to month 3 and 6 in low back pain intensity (LBPI) | 3 and 6 months |
Countries
United States
Outcome results
None listed