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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00599768

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	325
Study Start Date:	March 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A0081175, TWN-2006-CNS-001
Study First Received:	January 11, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00599768
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Signs and Symptoms
Neuromuscular Diseases
Neuralgia

Peripheral Nervous System Diseases
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009