Mechanism-based Choice of Therapy for Neuropathic Pain

NCT ID: NCT01359514

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-01-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Duloxetine

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

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

Pregabalin

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type 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

Interventions

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Pregabalin

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Calcium-channel blocker SSNRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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d_yarnitsky

Head of Neurology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Yarnitsky, Professor

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Michal Granot, PhD

Role: STUDY_DIRECTOR

Haifa University

Locations

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Rambam Medical center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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PostOperativePain05CTIL

Identifier Type: -

Identifier Source: org_study_id