Text Size

Neuropathic Pain Database (NePDatabase)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canada Foundation for Innovation
Pfizer
Information provided by (Responsible Party):
Dwight Moulin, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00669006
First received: April 28, 2008
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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 Database. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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))


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 ]

Estimated Enrollment: 900
Study Start Date: April 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (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
  • Estimated Life Expectancy of 2 years

Exclusion Criteria:

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

Locations
Canada, Ontario
London Health Sciences Centre- St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
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: Dwight Moulin, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00669006     History of Changes
Other Study ID Numbers: R-07-835, 13930E
Study First Received: April 28, 2008
Last Updated: April 11, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
 Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013