Overview

This trial is active, not recruiting.

Condition pain
Treatments pregabalin, duloxetine
Sponsor Rambam Health Care Campus
Start date April 2008
End date April 2012
Trial size 50 participants
Trial identifier NCT01359514, PostOperativePain05CTIL

Summary

Mechanism-based choice of therapy for neuropathic pain:

Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
pregabalin Calcium-channel blocker
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks
(Active Comparator)
duloxetine SSNRI
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

Primary Outcomes

Measure
clinical pain
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - patients planned for thoracotomy Exclusion Criteria: - 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

Additional Information

Official title Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile?
Principal investigator David Yarnitsky, Professor
Description Neuropathic or idiopathic pain patients will be assessed with the variety of pain tests including the conditioned pain modulation (CPM) and temporal summation (TS). Then, they will be offered on the double-blind design a several weeks treatment with either pregabalin or duloxetine. Patients will be followed-up weekly by phone for their pain relief and will be re-assessed in the lab toward the end of the treatment. The investigators suggest that patients with less-efficient CPM (deficient pain inhibition) will "earn" more pain relief from the treatment with duloxetine, while the patients with the enhanced pain summation will response better to pregabalin.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Rambam Health Care Campus.