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

• Sponsor: University of Kiel (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02666456
• Collaborator: (none)
• Enrollment: 1,500

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain; Polyneuropathy; Peripheral Nerve Injury	Other: QST, Questionnaires

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
• Study Start Date: Apr 1, 2016
• Anticipated Primary Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Cross-sectional cohort Patients with chronic peripheral neuropathic pain	Other: QST, Questionnaires; Assessment of sensory phenotype by QST and questionnaires
Longitudinal cohort Painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, Operation)	Other: QST, Questionnaires; Assessment of sensory phenotype by QST and questionnaires

Outcome Measures

Primary Outcome Measures

1. Somatosensory phenotype detected by quantitative sensory testing (QST) [Single assessment at baseline (cross-sectional study). Report of complete cohort data at study completion]

   The somatosensory phenotype will be assessed by quantitative sensory testing (QST) once at baseline

2. Change of neuropathic pain: Development and chronification of neuropathic pain detected by DN4 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.]

   Assessment with DN4 pain questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic peripheral neuropathic pain or

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

Exclusion Criteria:

• Minors

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Kiel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Funding source
• WEbsite

Publications

None provided.

• Responsible Party: Andras Binder, PD Dr. med., University of Kiel
• ClinicalTrials.gov Identifier: NCT02666456
• Other Study ID Numbers: DOLORisk WP4
• First Posted: Jan 28, 2016
• Last Update Posted: Jan 28, 2016
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neuralgia; Polyneuropathies; Peripheral Nerve Injuries

Study Results

No Results Posted as of Jan 28, 2016