Neuropathic PainNePDatabaseNCT00669006
Neuropathic Pain Database
An observational study of Neuropathic Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
To establish the infrastructure for a national neuropathic pain database. To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability, and quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuropathic Pain
- How many people
- 789 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to 24 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: New patients referred to the outpatient pain clinic with a diagnosis of Neuropathic Pain.
Who may be able to join
- Primarily Neuropathic Pain
- Able to give informed consent
- Estimated Life Expectancy of 2 years
Who cannot join
- Not primarily neuropathic pain
- Declined participation- too much traveling
- Declined participation- Unknown
- Declined participation- Other, specify
- Considered unreliable- personality disorder
- Considered unreliable- cognitive impairment
Show all 12Show fewer
- Considered unreliable- substance abuse
- Considered unreliable- Other
- Language barrier
- Exceeded quarterly quota
- Presentation with progressive or recurrent cancer, fibromyalgia, perineal pain of unknown etiology
- Other, specify
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre- St. Joseph's Health Care
London, Ontario, N6A 4V2
About this study
Official title: National Neuropathic Pain Database Study
To establish the infrastructure for a national neuropathic pain database.
To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability, and quality of life.
Read the detailed description
The database will provide standard information on demographics, diagnosis, treatment interventions and outcome modeled on guidelines from the expert panel on initiatives on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT)(Turk et al.,Pain 2003;106:337-345) The IMMPACT panel determined that patients should be evaluated according to six core domains as follows: Pain, physical functioning, emotional functioning, subject rating of global satisfaction with treatment, symptoms and adverse events and subject disposition.
The database will allow us to examine outcomes based on single (eg. pregabalin) and multiple (e.g tricyclic antidepressants and gabalin) therapeutic interventions. Standard guidelines for management of neuropathic pain acknowledge that polypharmacy is appropriate when individual first line treatments fail to provide adequate pain relief (Gilron I et al., CMAJ 2006; 175: 265-275; Attal N et al., European Journal of Neurology 2006; 13: 1153-1169)
- Conditions
- Neuropathic Pain
- Keywords
- neuropathic pain, database, prospective, national
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | New patients with a diagnosis of Neuropathic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the infrastructure for a national Neuropathic Pain Database.
To establish the infrastructure for a National Neuropathic Pain Database, with a composite primary outcome measure in average pain intensity (based on average pain intensity of BPI) and reduction in disability (based on Interference Scale Score of BPI))
Measured: 2 years
Secondary outcomes (1)
To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability and quality of life.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2012
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canada Foundation for Innovation, Pfizer
- Responsible party
- Sponsor
- Investigators
- Dwight Moulin, MD, Principal investigator, London Health Sciences Centre- St. Joseph's Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669006
- Sponsor's protocol ID
- R-07-835
- Other IDs
- 13930E
- Acronym
- NePDatabase
- Status last verified
- Feb 2021
- First submitted
- 28 Apr 2008
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Neuropathic Pain Database Study
- ClinicalTrials.gov ID
- NCT00669006
- Acronym / sponsor ID
- NePDatabase / R-07-835
- Conditions
- Neuropathic Pain
- Keywords
- neuropathic pain, database, prospective, national
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canada Foundation for Innovation, Pfizer
- Study start
- Apr 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 29 Apr 2008 (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 establish the infrastructure for a national neuropathic pain database.
To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability, and quality of life.
Detailed description
The database will provide standard information on demographics, diagnosis, treatment interventions and outcome modeled on guidelines from the expert panel on initiatives on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT)(Turk et al.,Pain 2003;106:337-345) The IMMPACT panel determined that patients should be evaluated according to six core domains as follows: Pain, physical functioning, emotional functioning, subject rating of global satisfaction with treatment, symptoms and adverse events and subject disposition.
The database will allow us to examine outcomes based on single (eg. pregabalin) and multiple (e.g tricyclic antidepressants and gabalin) therapeutic interventions. Standard guidelines for management of neuropathic pain acknowledge that polypharmacy is appropriate when individual first line treatments fail to provide adequate pain relief (Gilron I et al., CMAJ 2006; 175: 265-275; Attal N et al., European Journal of Neurology 2006; 13: 1153-1169)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –New patients with a diagnosis of Neuropathic Pain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- New patients referred to the outpatient pain clinic with a diagnosis of Neuropathic Pain.
Key inclusion criteria (3 listed)
- Primarily Neuropathic Pain
- Able to give informed consent
- Estimated Life Expectancy of 2 years
Key exclusion criteria (12 listed)
- Not primarily neuropathic pain
- Declined participation- too much traveling
- Declined participation- Unknown
- Declined participation- Other, specify
- Considered unreliable- personality disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish the infrastructure for a national Neuropathic Pain Database.
Time frame: 2 years
To establish the infrastructure for a National Neuropathic Pain Database, with a composite primary outcome measure in average pain intensity (based on average pain intensity of BPI) and reduction in disability (based on Interference Scale Score of BPI))
1 secondary outcome
To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability and quality of life.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
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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.
Dwight Moulin, MD principal investigator
London Health Sciences Centre- St. Joseph's Health Care
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 Neuropathic Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 12 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: finished, as of the sponsor's last update on 19 Oct 2021. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To establish the infrastructure for a national Neuropathic Pain Database. (time frame: 2 years). 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 19 Oct 2021.