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

Pfizer

Status: Terminated

Conditions: Low Back Pain

Treatments: Device: painPREMIER cohort; Other: Control cohort

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01838057

X9001010

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

103 participants in 2 patient groups

painPREMIER cohort

Treatment:

Device: painPREMIER cohort

Control cohort

Treatment:

Other: Control cohort