Mechanism-based Choice of Therapy for Neuropathic Pain

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Pregabalin; Drug: Duloxetine

• Registration Number: NCT01359514
• Lead Sponsor: Rambam Health Care Campus

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?

Detailed 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2010-07-10
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duloxetine	Pregabalin	-
Pregabalin	Duloxetine	-

Primary Outcome Measures

Name	Time	Method
clinical pain	One year	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.

Trial Locations

Locations (1)

Rambam Medical center; 🇮🇱 Haifa, Israel