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

April 4, 2016 updated by: Pfizer
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00100
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Members of the Terveystalo health insurance scheme presenting with a new episode of low back pain

Description

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

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
painPREMIER cohort
Other: painPREMIER cohort
Low back pain patients prospectively recruited during the study period and managed with painPREMIER.
Control cohort
Other: Control cohort
A matched group of low back pain patients not managed with painPREMIER.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Roland Morris Disability Questionnaire
Time Frame: 3 months
Change from baseline
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Roland Morris Disability Questionnaire
Time Frame: 6 months
Change from baseline
6 months
Self-reported low back pain intensity
Time Frame: 3 months
Change from baseline
3 months
Self-reported low back pain intensity and Roland Morris Disability Questionnaire
Time Frame: 3 months
Proportion of patients with at least 30% and 50% improvement
3 months
Global Assessment of Disease Activity
Time Frame: any time up to 6 months
Change from baseline
any time up to 6 months
SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)
Time Frame: 3 months
Change from baseline
3 months
EQ5-D Health Questionnaire
Time Frame: 3 months
Change from baseline
3 months
PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)
Time Frame: 3 months
Proportion of patients at risk for depression and/or anxiety
3 months
Self-reported depression PHQ-8 (Patient Health Questionnaire for Depression and Anxiety-8) and anxiety GAD-7 (Generalized Anxiety Disorder 7-item scale)
Time Frame: 3 months
Changes from baseline (if collected at BL)
3 months
Self-reported catastrophizing - Coping Strategies Questionnaire - Catastrophizing scale (CSQ-CAT)
Time Frame: 3 months
Changes from baseline
3 months
Self-reported absenteeism, presenteeism, lost productivity and activity, over prior 2 weeks, measured by Work Productivity and Activity Impairment (WPAI): Specific Helath Problem (Low Back Pain) questionnaire (painPREMIER cohort)
Time Frame: 3 months
Changes from baseline
3 months
All-cause absence days and costs associated with sick leave
Time Frame: 3 months
Comparison between painPREMIER cohort and control cohort
3 months
All-cause pharmacy and medical resource use/costs
Time Frame: 3 months
Comparison of pre and post-enrollment for both cohorts
3 months
Low back pain-related medical resource use/costs and pharmacy use/costs
Time Frame: 3 months
Comparison of pre and post-enrollment for both cohorts
3 months
Low back pain-specific medical resource use/costs
Time Frame: 3 months
Comparison of pre and post-enrollment for both cohorts
3 months
Total low back pain direct medical costs
Time Frame: 3 months
Comparison of pre and post-enrollment for both cohorts
3 months
Overall low back pain costs via claims data and imputed WPAI:LBP Work Productivity and Activity Impairment (WPAI): Specific Helath Problem (Low Back Pain) questionnaire
Time Frame: 3 months
Comparison between painPREMIER and control cohort
3 months
Overall all costs via claims and absence data
Time Frame: 3 months
Comparison between painPREMIER and control cohort
3 months
Patient Satisfaction
Time Frame: 3 months
Patient Satisfaction with painPREMIER
3 months
Specialist Occupational Health Provider Satisfaction
Time Frame: After enrolment complete estimated 4 months
Specialist Occupational Health Provider Satisfaction with painPREMIER
After enrolment complete estimated 4 months
Net Promoter Score
Time Frame: 1 week
Net Promoter Score
1 week
Semi-structured interview
Time Frame: 6 months
Patient feedback
6 months
Specialist Occupational Health Provider Engagement
Time Frame: 6 months
Specialist Occupational Health Provider Engagement with portal
6 months
Specialist Occupational Health Provider treatment recommendations
Time Frame: 6 months
Specialist Occupational Health Provider treatment recommendations vs painPREMIER treatment recommendations
6 months
Patient engagement/treatment adherence
Time Frame: 6 months
Platform use, CBST(Cognitive Behavioral Skills Training) module use and adherence to pharmacological therapy
6 months
TAMPA17 Scale for Kinesiophobia, PHQ4, PHQ8, (Patient Health Questionnaire for Depression and Anxiety-4 and 8), GAD7 (Generalized Anxiety Disorder 7-item scale)
Time Frame: Baseline
To evaluate the correlation between TAMPA17, PHQ4, PHQ8, GAD7 baseline assessments in the painPREMIER cohort
Baseline
painDETECT, TAMPA17 Scale for Kinesiophobia, LBPI (low back pain intensity) and RMDQ (Roland Morris Disability Questionnaire)
Time Frame: 3 months
To evaluate the change from baseline and correlation between the instruments in the painPREMIER cohort
3 months
Sub-group analysis
Time Frame: 6 months
To evaluate patterns of use and outcomes in subgroups
6 months
Daily sleep intereference rating scale
Time Frame: 3 months
Change from baseline
3 months
Daily sleep intereference rating scale
Time Frame: 6 months
Change from baseline
6 months
Self-reported low back pain intensity and Roland Morris Disability Questionnaire
Time Frame: 6 months
Proportion of patients with at least 30% and 50% improvement
6 months
SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)
Time Frame: 6 months
Change from baseline
6 months
EQ5-D Health Questionnaire
Time Frame: 6 months
Change from baseline
6 months
PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)
Time Frame: 6 months
Proportion of patients at risk for depression and/or anxiety
6 months
Self-reported depression PHQ-8 (Patient Health Questionnaire for Depression and Anxiety-8) and anxiety GAD-7 (Generalized Anxiety Disorder 7-item scale)
Time Frame: 6 months
Changes from baseline (if collected at BL)
6 months
Self-reported catastrophizing (CSQ-CAT) Coping Strategies Questionnaire - Catastrophizing scale
Time Frame: 6 months
Change from baseline
6 months
Self-reported absenteeism, presenteeism, lost productivity and activity, over prior 2 weeks, measured by Work Productivity and Activity Impairment (WPAI): Specific Helath Problem (Low Back Pain) questionnaire (painPREMIER cohort)
Time Frame: 6 months
Changes from baseline
6 months
All-cause absence days and costs associated with sick leave
Time Frame: 6 months
Comparison between painPREMIER cohort and control cohort
6 months
All-cause pharmacy and medical resource use/costs
Time Frame: 6 months
Comparison of pre and post-enrollment for both cohorts
6 months
Low back pain-related medical resource use/costs and pharmacy use/costs
Time Frame: 6 months
Comparison of pre and post-enrollment for both cohorts
6 months
Low back pain-specific medical resource use/costs
Time Frame: 6 months
Comparison of pre and post-enrollment for both cohorts
6 months
Total low back pain direct medical costs
Time Frame: 6 months
Comparison of pre and post-enrollment for both cohorts
6 months
Overall low back pain costs via claims data and imputed WPAI:LBP Work Productivity and Activity Impairment (WPAI): Specific Helath Problem (Low Back Pain) questionnaire
Time Frame: 6 months
Comparison between painPREMIER and control cohort
6 months
Overall all costs via claims and absence data
Time Frame: 6 months
Comparison between painPREMIER and control cohort
6 months
Patient Satisfaction
Time Frame: 6 months
Patient Satisfaction with painPREMIER
6 months
Net Promoter Score
Time Frame: 3 months
Net Promoter Score
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Terveystalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • X9001016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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