Mechanism-based Choice of Therapy for Neuropathic Pain
Recruitment status was Active, not recruiting
Mechanism-based choice of therapy for neuropathic pain:
Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?
|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?|
- 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.
|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)|
|Active Comparator: Duloxetine||
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||
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359514
|Rambam Medical center|
|Principal Investigator:||David Yarnitsky, Professor||Rambam Health Care Campus|
|Study Director:||Michal Granot, PhD||Haifa University|