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Peripheral Physiological Measures as Determinants of Pain Risk

DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02985294
Acronym
DOLORiskWP51
Enrollment
200
Registered
2016-12-07
Start date
2016-04-30
Completion date
2020-04-30
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Effects, Neuralgia, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Polyneuropathies

Keywords

Neuropathic pain, Quantitative Sensory Testing, Multiple Excitability Measures, Threshold Tracking

Brief summary

This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain electrophysiological pain phenotypes

Detailed description

Using MEM for peripheral sensory and motor axons we want to identify a set of excitability measures that: 1. Correlate with parameters of clinical pain and of pain processing in existing pain patients (cross sectional study), with the aim to obtain an objective Pain Biomarker. 2. Predict development of neuropathic pain in susceptible patients (longitudinal study). Neuropathic Pain Predictor for patients: i. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as vincristine

Interventions

OTHERMultiple Excitability Measures of peripheral nerves

The technique of threshold tracking can be used to obtain several measures of peripheral nerve excitability (Multiple Excitability Measures or MEM), such as refractoriness, supernormality, strength-duration time constant and 'threshold electrotonus' (i.e. the changes in threshold produced by long-lasting depolarizing or hyperpolarizing current pulses). Each of these measurements depends on membrane potential and on other biophysical properties of the axons. Many of these excitability parameters are very constant among different subjects, while other, such as the current/threshold parameters and the super/sub-excitability parameters, appear to be characteristic of an individual

Sponsors

University of Oxford
CollaboratorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University of Aarhus
CollaboratorOTHER
University of Dundee
CollaboratorOTHER
Neuroscience Technologies SLP, Barcelona
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Minors

Design outcomes

Primary

MeasureTime frameDescription
Electrophysiological pain phenotypes using MEM. Pain biomarkerSingle assessment (cross sectional study) at the first and only visitCorrelate with parameters of clinical pain and of pain processing in existing pain patients
Electrophysiological pain phenotypes using MEM. Pain predictorSingle assessment at baseline, before any procedure (surgery/chemotherapy)Predict development of neuropathic pain in susceptible patients

Countries

Spain

Contacts

Primary ContactRomà Solà, MD
rsola@nsc-tec.com0034 934020164

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026