Back to resultsMechanism-based Choice of Therapy for Neuropathic Pain
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pregabalin
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility 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
Sites / Locations
- Rambam Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Duloxetine
Pregabalin
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01359514
First Posted
July 10, 2010
Last Updated
October 10, 2017
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT01359514
Brief Title
Mechanism-based Choice of Therapy for Neuropathic Pain
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?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine
Arm Type
Active Comparator
Arm Title
Pregabalin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Calcium-channel blocker
Intervention Description
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
SSNRI
Intervention Description
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
Primary Outcome Measure Information:
Title
clinical pain
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Yarnitsky, Professor
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michal Granot, PhD
Organizational Affiliation
Haifa University
Official's Role
Study Director
Facility Information:
Facility Name
Rambam Medical center
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Mechanism-based Choice of Therapy for Neuropathic Pain
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