Pilot Evaluation to Assess the Clinical and Economic Impact of Pfizer's Pain Management Program (painPREMIER) in the Treatment of Low Back Pain, in an Occupational Health Care Setting in Finland

NCT01787565

Last updated date
Study Location
Pfizer Investigational Site
Helsinki, , 00100, Finland
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- New episode of low back pain

- Member of Terveystalo health insurance scheme

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


- Previous back pain related healthcare visit in the last 3 months


- Patients identified as having a 'red flag' condition

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Advanced Information
Descriptive Information
Brief Title Pilot Evaluation to Assess the Clinical and Economic Impact of Pfizer's Pain Management Program (painPREMIER) in the Treatment of Low Back Pain, in an Occupational Health Care Setting in Finland
Official Title Pilot Evaluation to Assess the Clinical and Economic Impact of Pfizer's Pain Management Program (painPREMIER) in the Treatment of Low Back Pain, in an Occupational Health Care Setting in Finland
Brief Summary The aim of this investigation is to determine whether the use of painPREMIER will significantly improve function in patients with low back pain in an occupational health clinical setting. painPREMIER is a tool that assists clinicians in the accurate diagnosis of back pain and associated problems in order to treat them most effectively.
Detailed Description Patients presenting at feeder sites to be referred to low back pain clinic and assessed for eligibility A decision was made to terminate this study on 09 OCT 2013. The study was terminated for operational/business reasons. This study was not terminated for reasons of safety or efficacy.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Members of the Terveystalo health insurance scheme presenting with a new episode of low back pain
Condition Back Pain
Intervention
  • Other: 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: Other: 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: February 12, 2014)
86
Original Estimated Enrollment
 (submitted: February 6, 2013)
200
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • New episode of low back pain
  • Member of Terveystalo health insurance scheme

Exclusion Criteria:

  • Previous back pain related healthcare visit in the last 3 months
  • Patients identified as having a 'red flag' condition
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 Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01787565
Other Study ID Numbers X9001016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Terveystalo
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2016