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Mechanism-based Choice of Therapy for Neuropathic Pain

Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01359514
Enrollment
32
Registered
2011-05-24
Start date
2008-04-30
Completion date
2014-01-31
Last updated
2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

Mechanism-based choice of therapy for neuropathic pain: Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

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.

Interventions

DRUGPregabalin

Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks

DRUGDuloxetine

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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
clinical painOne yearThe 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026