Pain Prevention and Treatment Through the Enhancement of the Anti-nociceptive Component of Pain Modulation Profiles
1 other identifier
interventional
5
1 country
1
Brief Summary
To utilize the plasticity of the central pain pathways in order to (i) shift individuals with a pro-nociceptive pain modulation profile towards an anti-nociceptive one, and (ii) assess its relevance in minimizing pain-derived morbidity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedOctober 4, 2017
October 1, 2017
1 year
December 18, 2013
October 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The changes in pain response after administration of duloxetine and pregabalin
The changes in the excitatory and inhibitory pain modulation responses (assessed by temporal summation and conditioned pain modulation) will be examined before and after the administration of duloxetine and pregabalin in the set of pre and post coronary artery bypass grafting surgery.
3 years
Study Arms (3)
Duloxetine
ACTIVE COMPARATORDUL 60mg x once a day x 2 days. This arm will also take 2 non-active placebo x once a day x 2 days
Pregabalin
ACTIVE COMPARATORPGB 150mg x twice a day x 2 days
Placebo
PLACEBO COMPARATORNon active placebo x twice a day x 2 days
Interventions
Eligibility Criteria
You may qualify if:
- Otherwise healthy, age 18-75.
You may not qualify if:
- Regular use of analgesia for any purpose, including SNRIs, gabapentins, COX inhibitors.
- Presence of diagnosed chronic pain disorders, psychiatric disorders, cognitive and /or neurological deficit.
- Inability to give informed consent, communicate and understand the purpose and instructions of this study.
- Pregnant or nursing women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Health Care Campus
Haifa, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Yarnitsky, Professor
Rambam Health Care Campus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Head of Neurology Deapartment
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 24, 2013
Study Start
January 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
October 4, 2017
Record last verified: 2017-10