Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00599768
First received: January 11, 2008
Last updated: November 19, 2009
Last verified: November 2009
  Purpose

This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied in Taiwanese subjects at the clinical setting.


Condition Intervention
Neuralgia
Nerve Pain
Neuropathic Pain
Other: ID-Pain DN4 Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Determine the optimal cut-off score of ID Pain-T Questionnaire for screening of neuropathic pain [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the predictive power of ID Pain-T Questionnaire for diagnosis of neuropathic pain [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Develop and evaluate validity of a short form diagnostic tool based on DN4 structure [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment: 325
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: ID-Pain DN4 Questionnaire
    This is a non-interventional questionnaire validation study
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients of non-headache pain for more than 30 days and those whose age is more than 18 years old

Criteria

Inclusion Criteria:

  • Subjects without headache pain over 30 days and at least 18 years old who will visit the clinic, inclusive of male and female.
  • Subjects who are able to complete the ID Pain-T Questionnaire.

Exclusion Criteria:

  • Subjects who are illiterate or unable to complete questionnaire.
  • Subjects who are currently participating in another study or have participated in another pain study within one month of study entry.
  • Subjects with low back pain are unable to participate in this study; as the sciatica caused by the piriformis (exclusive of the other types of sciatic pain), lumbago, unclear identification in nerve injury (e.g. complex regional pain syndrome type I) or mixed origin (e.g. cancer pain).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00599768

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00599768     History of Changes
Other Study ID Numbers: A0081175, TWN-2006-CNS-001
Study First Received: January 11, 2008
Last Updated: November 19, 2009
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on October 21, 2014