Low Back PainNCT01838057
Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting
An observational study of Low Back Pain, run by Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- painPREMIER cohort
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 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: Patients with low back pain
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Fayetteville, Georgia, 30214
About this study
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
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.
- Conditions
- Low Back Pain
- Being tested
- painPREMIER cohort, Control cohort
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painPREMIER cohortDevice
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 group | Role | What they receive |
|---|---|---|
| painPREMIER cohort | Not described Receives: Device: painPREMIER cohort | |
| Control cohort | Not described Receives: Other: Control cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 month
Secondary outcomes (14)
Change from baseline to month 6 in RMDQ total score
Measured: 3 and 6 months
Change from baseline to month 3 and 6 in low back pain intensity (LBPI)
Measured: 3 and 6 months
Change from baseline to month 3 and 6 daily sleep interference rating scale (DSIRS)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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 >/=
Measured: 3 and 6 months
3 on PHQ-4)
Measured: 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])
Measured: 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
Measured: 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
Measured: 3 and 6 months
Patient satisfaction with painPRIMER
Measured: 3 and 6 months
Healthcare professional satisfaction with painPRIMER
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: The study was terminated on 02-Jun-2014 due to slow enrollment. The study was not terminated for reasons of either safety or efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Piedmont Healthcare System
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838057
- Sponsor's protocol ID
- X9001010
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01838057
- Acronym / sponsor ID
- X9001010
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated on 02-Jun-2014 due to slow enrollment. The study was not terminated for reasons of either safety or efficacy.
- Enrolment
- 103 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Piedmont Healthcare System
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| painPREMIER cohort | – | Device: painPREMIER cohort |
| Control cohort | – | Other: Control cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low back pain
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| painPREMIER cohortLow back pain patients prospectively recruited during the study period and managed with painPREMIER. | Device | painPREMIER cohort |
| Control cohortA matched group of low back pain patients not managed with painPREMIER. | Other | Control cohort |
Primary outcome
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
14 secondary outcomes
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
Results and safety
The study was stopped early (reason given: The study was terminated on 02-Jun-2014 due to slow enrollment. The study was not terminated for reasons of either safety or efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Pfizer at 1 site in United States.
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 3 inclusion and 3 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 16 Apr 2015. 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 United States. 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: The study was terminated on 02-Jun-2014 due to slow enrollment. The study was not terminated for reasons of either safety or efficacy.). 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: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2015.