Neuropathic Pain Database

NCT00669006

Last updated date
Study Location
London Health Sciences Centre- St. Joseph's Health Care
London, Ontario, N6A 4V2, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuropathic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Primarily Neuropathic Pain

- Able to give informed consent

- Estimated Life Expectancy of 2 years

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title Neuropathic Pain Database
Official Title National Neuropathic Pain Database Study
Brief 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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population New patients referred to the outpatient pain clinic with a diagnosis of Neuropathic Pain.
Condition Neuropathic Pain
Intervention Not Provided
Study Groups/Cohorts 1
New patients with a diagnosis of Neuropathic Pain
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 28, 2008)
900
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00669006
Other Study ID Numbers R-07-835
13930E
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lawson Health Research Institute
Study Sponsor Lawson Health Research Institute
Collaborators
  • Canada Foundation for Innovation
  • Pfizer
Investigators
Principal Investigator:Dwight Moulin, MDLondon Health Sciences Centre- St. Joseph's Health Care
PRS Account Lawson Health Research Institute
Verification Date March 2019