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

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

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Control cohort; Device: painPREMIER cohort

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Fayetteville, Georgia, United States, 30214
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with low back pain

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
painPREMIER cohort	Device: painPREMIER cohort; Low back pain patients prospectively recruited during the study period and managed with painPREMIER.
Control cohort	Other: Control cohort; A matched group of low back pain patients not managed with painPREMIER.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Piedmont Healthcare System

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 15, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Estimate): April 16, 2015
• Last Update Submitted That Met QC Criteria: April 15, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: X9001010