Suspended

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

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What is being collected

Device Data

+ other Data

Collected from today forward - Prospective
DeviceOther
Who is being recruted

Back Pain+3

+ Neurologic Manifestations

+ Pain

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2013
See protocol details

Summary

Principal SponsorPfizer
Last updated: April 16, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorPfizer
Last updated: April 16, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

103 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Back PainNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsLow Back Pain

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Pfizer Investigational Site

Fayetteville, United StatesOpen Pfizer Investigational Site in Google Maps
SuspendedOne Study Center