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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01838057
• Other study ID #: X9001010
• Status: Terminated
• Phase: N/A
• First received: April 15, 2013
• Last updated: April 15, 2015
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 103
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• painPREMIER cohort
Low back pain patients prospectively recruited during the study period and managed with painPREMIER.

Other:
• Control cohort
A matched group of low back pain patients not managed with painPREMIER.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Fayetteville	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Piedmont Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Change from baseline to month 6 in RMDQ total score		3 and 6 months	No
Secondary	Change from baseline to month 3 and 6 in low back pain intensity (LBPI)		3 and 6 months	No
Secondary	Change from baseline to month 3 and 6 daily sleep interference rating scale (DSIRS)		3 and 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	3 on PHQ-4)		3 and 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Patient satisfaction with painPRIMER		3 and 6 months	No
Secondary	Healthcare professional satisfaction with painPRIMER		6 months	No

External Links

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