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AzTrials

Back PainNCT01787565

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

An observational study of Back Pain, run by Pfizer at 1 site in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Back Pain
What is being tested?
painPREMIER cohort
How many people
86 participants
Where
1 siteFinland
Study dates
Jan 2013to Jan 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Previous back pain related healthcare visit in the last 3 months
  • Patients identified as having a 'red flag' condition

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Pfizer Investigational Site

    Helsinki, 00100

Other trials in Finland

About this study

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.

Read the 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.

Conditions
Back Pain
Being tested
painPREMIER cohort, Control cohort
Keywords
non-interventional, clinical, investigation, low, back, pain, painPREMIER
Medical subject headings
Back Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • painPREMIER cohortOther

    Low back pain patients prospectively recruited during the study period and managed with painPREMIER.

  • Control cohortOther

    A matched group of low back pain patients not managed with painPREMIER.

Study groups in NCT01787565
Study groupRoleWhat they receive
painPREMIER cohortNot described
Receives: Other: painPREMIER cohort
Control cohortNot described
Receives: Other: Control cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Roland Morris Disability Questionnaire

    Change from baseline

    Measured: 3 months

Secondary outcomes (45)

  1. Roland Morris Disability Questionnaire

    Change from baseline

    Measured: 6 months

  2. Self-reported low back pain intensity

    Change from baseline

    Measured: 3 months

  3. Self-reported low back pain intensity and Roland Morris Disability Questionnaire

    Proportion of patients with at least 30% and 50% improvement

    Measured: 3 months

  4. Global Assessment of Disease Activity

    Change from baseline

    Measured: any time up to 6 months

  5. SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)

    Change from baseline

    Measured: 3 months

  6. EQ5-D Health Questionnaire

    Change from baseline

    Measured: 3 months

  7. PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)

    Proportion of patients at risk for depression and/or anxiety

    Measured: 3 months

  8. Self-reported depression PHQ-8 (Patient Health Questionnaire for Depression and Anxiety-8) and anxiety GAD-7 (Generalized Anxiety Disorder 7-item scale)

    Changes from baseline (if collected at BL)

    Measured: 3 months

  9. Self-reported catastrophizing - Coping Strategies Questionnaire - Catastrophizing scale (CSQ-CAT)

    Changes from baseline

    Measured: 3 months

  10. 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)

    Changes from baseline

    Measured: 3 months

  11. All-cause absence days and costs associated with sick leave

    Comparison between painPREMIER cohort and control cohort

    Measured: 3 months

  12. All-cause pharmacy and medical resource use/costs

    Comparison of pre and post-enrollment for both cohorts

    Measured: 3 months

  13. Low back pain-related medical resource use/costs and pharmacy use/costs

    Comparison of pre and post-enrollment for both cohorts

    Measured: 3 months

  14. Low back pain-specific medical resource use/costs

    Comparison of pre and post-enrollment for both cohorts

    Measured: 3 months

  15. Total low back pain direct medical costs

    Comparison of pre and post-enrollment for both cohorts

    Measured: 3 months

  16. 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

    Comparison between painPREMIER and control cohort

    Measured: 3 months

  17. Overall all costs via claims and absence data

    Comparison between painPREMIER and control cohort

    Measured: 3 months

  18. Patient Satisfaction

    Patient Satisfaction with painPREMIER

    Measured: 3 months

  19. Specialist Occupational Health Provider Satisfaction

    Specialist Occupational Health Provider Satisfaction with painPREMIER

    Measured: After enrolment complete estimated 4 months

  20. Net Promoter Score

    Net Promoter Score

    Measured: 1 week

  21. Semi-structured interview

    Patient feedback

    Measured: 6 months

  22. Specialist Occupational Health Provider Engagement

    Specialist Occupational Health Provider Engagement with portal

    Measured: 6 months

  23. Specialist Occupational Health Provider treatment recommendations

    Specialist Occupational Health Provider treatment recommendations vs painPREMIER treatment recommendations

    Measured: 6 months

  24. Patient engagement/treatment adherence

    Platform use, CBST(Cognitive Behavioral Skills Training) module use and adherence to pharmacological therapy

    Measured: 6 months

  25. TAMPA17 Scale for Kinesiophobia, PHQ4, PHQ8, (Patient Health Questionnaire for Depression and Anxiety-4 and 8), GAD7 (Generalized Anxiety Disorder 7-item scale)

    To evaluate the correlation between TAMPA17, PHQ4, PHQ8, GAD7 baseline assessments in the painPREMIER cohort

    Measured: Baseline

  26. painDETECT, TAMPA17 Scale for Kinesiophobia, LBPI (low back pain intensity) and RMDQ (Roland Morris Disability Questionnaire)

    To evaluate the change from baseline and correlation between the instruments in the painPREMIER cohort

    Measured: 3 months

  27. Sub-group analysis

    To evaluate patterns of use and outcomes in subgroups

    Measured: 6 months

  28. Daily sleep intereference rating scale

    Change from baseline

    Measured: 3 months

  29. Daily sleep intereference rating scale

    Change from baseline

    Measured: 6 months

  30. Self-reported low back pain intensity and Roland Morris Disability Questionnaire

    Proportion of patients with at least 30% and 50% improvement

    Measured: 6 months

  31. SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)

    Change from baseline

    Measured: 6 months

  32. EQ5-D Health Questionnaire

    Change from baseline

    Measured: 6 months

  33. PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)

    Proportion of patients at risk for depression and/or anxiety

    Measured: 6 months

  34. Self-reported depression PHQ-8 (Patient Health Questionnaire for Depression and Anxiety-8) and anxiety GAD-7 (Generalized Anxiety Disorder 7-item scale)

    Changes from baseline (if collected at BL)

    Measured: 6 months

  35. Self-reported catastrophizing (CSQ-CAT) Coping Strategies Questionnaire - Catastrophizing scale

    Change from baseline

    Measured: 6 months

  36. 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)

    Changes from baseline

    Measured: 6 months

  37. All-cause absence days and costs associated with sick leave

    Comparison between painPREMIER cohort and control cohort

    Measured: 6 months

  38. All-cause pharmacy and medical resource use/costs

    Comparison of pre and post-enrollment for both cohorts

    Measured: 6 months

  39. Low back pain-related medical resource use/costs and pharmacy use/costs

    Comparison of pre and post-enrollment for both cohorts

    Measured: 6 months

  40. Low back pain-specific medical resource use/costs

    Comparison of pre and post-enrollment for both cohorts

    Measured: 6 months

  41. Total low back pain direct medical costs

    Comparison of pre and post-enrollment for both cohorts

    Measured: 6 months

  42. 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

    Comparison between painPREMIER and control cohort

    Measured: 6 months

  43. Overall all costs via claims and absence data

    Comparison between painPREMIER and control cohort

    Measured: 6 months

  44. Patient Satisfaction

    Patient Satisfaction with painPREMIER

    Measured: 6 months

  45. Net Promoter Score

    Net Promoter Score

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Why it stopped: See termination reason in detailed description.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01787565
Sponsor's protocol ID
X9001016
Status last verified
Apr 2016
First submitted
22 Jan 2013
Last updated
6 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Back Pain, run by Pfizer at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Roland Morris Disability Questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01787565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.

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