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

NCT01838057 | Terminated

• 1 other identifier: X9001010
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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

Study Arms (2)

painPREMIER cohort

Device: painPREMIER cohort

Control cohort

Other: Control cohort

Interventions

painPREMIER cohort DEVICE

Low back pain patients prospectively recruited during the study period and managed with painPREMIER.

painPREMIER cohort

Control cohort OTHER

A matched group of low back pain patients not managed with painPREMIER.

Control cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with low back pain

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Piedmont Healthcare System: collaborator

Study Sites (1)

Pfizer Investigational Site

Fayetteville, Georgia, 30214, United States

Location

Related Links

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

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 23, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

US (1)