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Trial record 1 of 1 for:    NCT01838057
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Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting

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ClinicalTrials.gov Identifier: NCT01838057
Recruitment Status : Terminated (The study was terminated on 02-Jun-2014 due to slow enrollment. The study was not terminated for reasons of either safety or efficacy.)
First Posted : April 23, 2013
Last Update Posted : April 16, 2015
Sponsor:
Collaborator:
Piedmont Healthcare System
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date April 15, 2013
First Posted Date April 23, 2013
Last Update Posted Date April 16, 2015
Study Start Date June 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2013)
  • 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 [ Time Frame: 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 [ Time Frame: 6 month ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2013)
  • Change from baseline to month 6 in RMDQ total score [ Time Frame: 3 and 6 months ]
  • Change from baseline to month 3 and 6 in low back pain intensity (LBPI) [ Time Frame: 3 and 6 months ]
  • Change from baseline to month 3 and 6 daily sleep interference rating scale (DSIRS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 and 6 months ]
  • Quality of Life in the painPRIMER cohort vs control cohort: Change from baseline to month 3 and 6 in the Short- Form. [ Time Frame: 3 and 6 months ]
  • psychosocial outcomes in the painPRIMER cohort and control cohort: Proportion of patients at risk for depression and/or anxiety (via Patient Health Questionnaire-4 [PHQ-4]) at baseline, 3 and 6 months [ Time Frame: 3 and 6 months ]
  • psychosocial outcomes in the painPRIMER cohort and control cohort: Changes from baseline to month 3 and 6 in patients at risk for depression (PHQ-8) and anxiety (GAD-7), among those receiving the instrument (NOTE: only given to those scoring >/= [ Time Frame: 3 and 6 months ]
  • 3 on PHQ-4) [ Time Frame: 3 and 6 months ]
  • psychosocial outcomes in the painPRIMER cohort and control cohort: Change from baseline to month 3 and 6 in catastrophizing (Coping Strategies Questionnaire -Catastrophizing [CSQ-CAT]) [ Time Frame: 3 and 6 months ]
  • productivity/indirect costs: Changes from baseline to month 3 and 6 in Work Productivity and Activity Impairment (WPAI): Specific Health Problem, LBP [ Time Frame: 3 and 6 months ]
  • Direct cost: Comparison of resource use/direct medical costs, in 6 months pre-enrollment/index date and 6 months post-enrollment/index date via insurance claims data for painPRIMER and control cohorts [ Time Frame: 3 and 6 months ]
  • Patient satisfaction with painPRIMER [ Time Frame: 3 and 6 months ]
  • Healthcare professional satisfaction with painPRIMER [ Time Frame: 6 months ]
Original Secondary Outcome Measures
 (submitted: April 18, 2013)
  • Change from baseline to month 6 in RMDQ total score [ Time Frame: 3 and 6 months ]
  • Change from baseline to month 3 and 6 in low back pain intensity (LBPI) [ Time Frame: 3 and 6 months ]
  • Change from baseline to month 3 and 6 daily sleep interference rating scale (DSIRS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 and 6 months ]
  • Quality of Life in the painPRIMER cohort vs control cohort: Change from baseline to month 3 and 6 in the Short- Form. [ Time Frame: 3 and 6 months ]
  • psychosocial outcomes in the painPRIMER cohort and control cohort: Proportion of patients at risk for depression and/or anxiety (via Patient Health Questionnaire-4 [PHQ-4]) at baseline, 3 and 6 months [ Time Frame: 3 and 6 months ]
  • psychosocial outcomes in the painPRIMER cohort and control cohort: Changes from baseline to month 3 and 6 in patients at risk for depression (PHQ-8) and anxiety (GAD-7), among those receiving the instrument [ Time Frame: 3 and 6 months ]
    (NOTE: only given to those scoring >/= 3 on PHQ-4)
  • psychosocial outcomes in the painPRIMER cohort and control cohort: Change from baseline to month 3 and 6 in catastrophizing (Coping Strategies Questionnaire -Catastrophizing [CSQ-CAT]) [ Time Frame: 3 and 6 months ]
  • productivity/indirect costs: Changes from baseline to month 3 and 6 in Work Productivity and Activity Impairment (WPAI): Specific Health Problem, LBP [ Time Frame: 3 and 6 months ]
  • Direct cost: Comparison of resource use/direct medical costs, in 6 months pre-enrollment/index date and 6 months post-enrollment/index date via insurance claims data for painPRIMER and control cohorts [ Time Frame: 3 and 6 months ]
  • Patient satisfaction with painPRIMER [ Time Frame: 3 and 6 months ]
  • Healthcare professional satisfaction with painPRIMER [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
PRS Account Pfizer
Verification Date April 2015