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Mechanism-based Choice of Therapy for Neuropathic Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359514
First Posted: May 24, 2011
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
d_yarnitsky, Rambam Health Care Campus
  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: Triple (Participant, Care Provider, 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 d_yarnitsky, Rambam Health Care Campus:

Primary Outcome Measures:
  • clinical pain [ Time Frame: 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.


Enrollment: 32
Actual Study Start Date: April 2008
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: d_yarnitsky, Head of Neurology Department, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01359514     History of Changes
Other Study ID Numbers: PostOperativePain05CTIL
First Submitted: July 10, 2010
First Posted: May 24, 2011
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Duloxetine Hydrochloride
Calcium Channel Blockers
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Antidepressive Agents
Dopamine Agents