Mechanism-based Choice of Therapy for Neuropathic Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Rambam Health Care Campus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01359514
First received: July 10, 2010
Last updated: May 23, 2011
Last verified: December 2007
  Purpose

Mechanism-based choice of therapy for neuropathic pain:

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


Condition Intervention
Pain
Drug: Pregabalin
Drug: Duloxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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?

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • clinical pain [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Duloxetine Drug: Pregabalin
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks
Other Name: Calcium-channel blocker
Active Comparator: Pregabalin Drug: Duloxetine
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
Other Name: SSNRI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01359514

Locations
Israel
Rambam Medical center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: David Yarnitsky, Professor Rambam Health Care Campus
Study Director: Michal Granot, PhD Haifa University
  More Information

No publications provided

Responsible Party: Prof. David Yarnitsky, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01359514     History of Changes
Other Study ID Numbers: PostOperativePain05CTIL
Study First Received: July 10, 2010
Last Updated: May 23, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Calcium Channel Blockers
Duloxetine
Pregabalin
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Anticonvulsants
Antidepressive Agents
Cardiovascular Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014