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

NCT01838057

Last updated date
Study Location
Pfizer Investigational Site
Fayetteville, Georgia, 30214, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with low back pain
Condition 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.
Study Groups/Cohorts
  • painPREMIER cohort
    Intervention: Device: painPREMIER cohort
  • Control cohort
    Intervention: Other: Control cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 15, 2014)
103
Original Estimated Enrollment
 (submitted: April 18, 2013)
600
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01838057
Other Study ID Numbers X9001010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Piedmont Healthcare System
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2015