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Mechanism-based choice of therapy for neuropathic pain:
Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Active Comparator |
| |
| Pregabalin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical pain | 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. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Yarnitsky, Professor | Rambam Health Care Campus | Principal Investigator |
| Michal Granot, PhD | Haifa University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical center | Haifa | Israel |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D002121 | Calcium Channel Blockers |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Duloxetine | Drug | 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 |
|
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D045505 | Physiological Effects of Drugs |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |