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NCT02666456 Clinical Trial

The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:
DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02666456
Other study ID # DOLORisk WP4
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 11, 2016
Last updated January 25, 2016
Start date April 2016

Study information
Verified date January 2016
Source University of Kiel
Contact Andreas Binder, MD
Phone +49 431 597
Email andreas.binder@uksh.de
Is FDA regulated No
Health authority Germany: Ethic committee Kiel
Study type Observational

Clinical Trial Summary

Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk factors for neuropathic pain development and chronification in painless and chronic pain patients.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1500
Est. completion date
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chronic peripheral neuropathic pain or

- Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)

Exclusion Criteria:

- Minors

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• QST, Questionnaires
Assessment of sensory phenotype by QST and questionnaires

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Kiel

Outcome
Type Measure Description Time frame Safety issue
Primary Somatosensory phenotype detected by quantitative sensory testing (QST) The somatosensory phenotype will be assessed by quantitative sensory testing (QST) once at baseline Single assessment at baseline (cross-sectional study). Report of complete cohort data at study completion No
Primary Change of neuropathic pain: Development and chronification of neuropathic pain detected by DN4 questionnaire Assessment with DN4 pain questionnaire Assessment of change of neuropathic pain from baseline and 6 months after study enrollment (longitudinal study). Report of complete cohort data at study completion. No
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