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
Recruitment status was Active, not recruiting
Sponsor:
Rambam Health Care Campus
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
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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
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 Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Calcium Channel Blockers Duloxetine Pregabalin Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013