Reliability of Measuring Conditioned Pain Modulation With the Nociceptive Withdrawal Reflex
2 other identifiers
interventional
39
1 country
1
Brief Summary
Conditioned pain modulation is the ability of the spine to describe changes in pain perception, if two different painful stimulations take place. The reliability of the conditioned pain modulation has not been studied, the instruments used to measure the conditioned pain modulation are sparse and have proven difficult to use in a well reproductible way. This study is using an existing pain test, relying on the reflex in a muscle after a painful electrical stimulation. We will test 34 healthy volunteers in order to test the reliability of the conditioned pain modulation with the nociceptive withdrawal reflex combined to a ice water test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy-volunteers
Started Jun 2012
Shorter than P25 for not_applicable healthy-volunteers
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
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 5, 2012
CompletedFirst Posted
Study publicly available on registry
July 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJanuary 21, 2013
January 1, 2013
2 months
July 5, 2012
January 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reliability of CPM with the nociceptive withdrawal reflex
two minutes after the cold pressor test
Secondary Outcomes (2)
Reliability of CPM with electric pain detection threshold
two minutes after the cold pressor test
Reliability of CPM with suprathreshold electrical pain detection threshold stimulation
two minutes after the cold pressor test
Study Arms (1)
Reliability
OTHERThe same testing procedure is repeated after a delay of 7 days to test the reliability of the measure
Interventions
Measure of the conditioned pain modulation with the nociceptive withdrawal reflex and ice water stimulation
Eligibility Criteria
You may qualify if:
- Male Gender
- Age 18-65
- Signed Informed Consent
You may not qualify if:
- Signs or suspicion of neurologic dysfunction or disease
- Ongoing treatment with any drug known to influence pain modulation: any analgesic, antidepressant, anticonvulsant or benzodiazepine
- Intake of any analgesic drug during the 48h preceding the experiment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insel Gruppe AG, University Hospital Bernlead
- Aalborg Universitycollaborator
Study Sites (1)
Dep. of Anesthesiology and Pain Medicine, Bern University Hospital
Bern, 3010, Switzerland
Related Publications (1)
Biurrun Manresa JA, Fritsche R, Vuilleumier PH, Oehler C, Morch CD, Arendt-Nielsen L, Andersen OK, Curatolo M. Is the conditioned pain modulation paradigm reliable? A test-retest assessment using the nociceptive withdrawal reflex. PLoS One. 2014 Jun 20;9(6):e100241. doi: 10.1371/journal.pone.0100241. eCollection 2014.
PMID: 24950186DERIVED
Study Officials
- STUDY DIRECTOR
Michele Curatolo, MD
University Hosptial Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2012
First Posted
July 10, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
January 21, 2013
Record last verified: 2013-01