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Neuropathic Pain Database (NePDatabase)
This study is currently recruiting participants.
Verified by Lawson Health Research Institute, April 2008
Sponsors and Collaborators: Lawson Health Research Institute
Canada Foundation for Innovation
Pfizer
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00669006
  Purpose

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.


Condition
Neuropathic Pain

U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: National Neuropathic Pain Database Study

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • To establish the infrastructure for a national neuropathic pain databasse [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability and quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 900
Study Start Date: April 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
New patients with a diagnosis of Neuropathic Pain

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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

New patients referred to the outpatient pain clinic with a diagnosis of Neuropathic Pain.

Criteria

Inclusion Criteria:

  • Primarily Neuropathic Pain
  • able to give informed consent

Exclusion Criteria:

  • Not primarily neuropathic pain
  • Declined participation- too much traveling
  • Considered unreliable- personality disorder
  • Considered unreliable- cognitive impairment
  • Considered unreliable- substance abuse
  • Language barrier
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669006

Contacts
Contact: Dwight Moulin, MD 519-685-8500 ext 58661 dwight.moulin@lhsc.on.ca
Contact: Charlene M Bartha, RN 519-685-8500 ext 74819 charlene.bartha@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre- St. Joseph's Health Care Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Dwight Moulin, MD     519-685-8661     dwight.moulin@lhsc.on.ca    
Contact: Charlene M Bartha, RN     519-685-8500 ext 74819     charlene.bartha@lhsc.on.ca    
Principal Investigator: Dwight Moulin, MD            
Sponsors and Collaborators
Lawson Health Research Institute
Canada Foundation for Innovation
Pfizer
Investigators
Principal Investigator: Dwight Moulin, MD London Health Sciences Centre- St. Joseph's Health Care
  More Information

No publications provided

Responsible Party: Lawson Health Research Institute ( Dr. Dwight Moulin )
Study ID Numbers: R-07-835, 13930E
Study First Received: April 28, 2008
Last Updated: April 28, 2008
ClinicalTrials.gov Identifier: NCT00669006  
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
neuropathic pain
database
prospective
national

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on February 12, 2009