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

NCT02666456 | Unknown

• 1 other identifier: DOLORisk WP4
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuropathic Pain; Polyneuropathy; Peripheral Nerve Injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

Study Arms (2)

Cross-sectional cohort

Patients with chronic peripheral neuropathic pain

Other: QST, Questionnaires

Longitudinal cohort

Painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, Operation)

Other: QST, Questionnaires

Interventions

QST, Questionnaires OTHER

Assessment of sensory phenotype by QST and questionnaires

Cross-sectional cohort; Longitudinal cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Painless patients and patients with chronic peripheral neuropathic pain.

You may qualify if:

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

You may not qualify if:

• Minors

Sponsors & Collaborators

• University of Kiel: lead

Related Links

• Funding source
• WEbsite

MeSH Terms

Conditions

Neuralgia; Polyneuropathies; Peripheral Nerve Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Andreas Binder, MD

CONTACT

+49 431 597; andreas.binder@uksh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 28, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2019
• Last Updated: January 28, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share