Mechanism-based Choice of Therapy for Neuropathic Pain

NCT01359514 | Completed

• 1 other identifier: PostOperativePain05CTIL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanism-based choice of therapy for neuropathic pain: Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• clinical pain

  The pain relief will be achieved by treatment with duloxetine or pregabalin. We propose that the patients with deficient pain inhibition (As assessed by conditioned pain modulation lab test) will have better drug efficacy of cymbalta which restores the deficient level of serotonin and noradrenalin. In turn, pregabalin will be more effective in patients with enhance central sensitization of pain as measured by temporal summation assessment. In line, CPM and TS will be modulated by the treatment, in parallel with the analgesic effect.

  One year

Study Arms (2)

Duloxetine

ACTIVE COMPARATOR

Drug: Pregabalin

Pregabalin

ACTIVE COMPARATOR

Drug: Duloxetine

Interventions

Pregabalin DRUG

Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks

Also known as: Calcium-channel blocker

Duloxetine

Duloxetine DRUG

Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 5 weeks

Also known as: SSNRI

Pregabalin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients planned for thoracotomy

You may not qualify if:

• age below 18 and above 75 years
• patients with psychiatric or cognitive dysfunction precluding use of psychophysics
• those who cannot communicate in Hebrew
• patients with existing thoracic or other current chronic pain

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical center

Haifa, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Pregabalin; Calcium Channel Blockers; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Yarnitsky, Professor

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

• Michal Granot, PhD

  Haifa University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology Department

Study Record Dates

• First Submitted: July 10, 2010
• First Posted: May 24, 2011
• Study Start: April 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

IL (1)