'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug

• Status: Completed
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Introduction Treatment of neuropathic pain has been a goal of numerous research projects for the last half century, with overall disappointing results. These poor achievements are in contrast with substantial advancements in the understanding of pain mechanisms, and numerous molecules developed to tackle them. The need to better identify patients likely to respond to treatment comes from the neuropathic pain experts in regards to the pharmacological domain.

The basic assertion of this project is that the pain modulation profile is altered in pain patients toward a pro-nociceptive mode, and that the specific single or multiple dysfunctions of pain modulation that underlie this pro-nociceptivity should be targeted by therapeutic lines that can reverse the modulation back toward eu-nociceptivity.

The aim of this amendment is to demonstrate that pain treatment efficacy for painful diabetic neuropathy can be optimized by individualizing pharmacological treatment choice along 'fix the dysfunction' concept

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborator: Israel Science Foundation
• Treatments: Duloxetine Hydrochloride; Pregabalin

Criteria

Inclusion Criteria:

• age of 18-80 yrs,

• both genders, * non-pregnant or breast feeding,

• free of significant chronic pain syndromes other than the neuropathy,

• free of major neurological or psychiatric disorders such as dementia, psychosis and similar.

Exclusion Criteria:

*communication and language difficulties that hinder their performance in the various tests.

One-hundred healthy subjects will be recruited, with the same inclusion exclusion criteria.