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Reliability of Measuring Conditioned Pain Modulation With the Nociceptive Withdrawal Reflex

This study has been completed.
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01636440
First received: July 5, 2012
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Healthy Volunteers
Device: Conditioned Pain Modulation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Reliability of Measuring Conditioned Pain Modulation With the Nociceptive Withdrawal Reflex

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Reliability of CPM with the nociceptive withdrawal reflex [ Time Frame: two minutes after the cold pressor test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reliability of CPM with electric pain detection threshold [ Time Frame: two minutes after the cold pressor test ] [ Designated as safety issue: No ]
  • Reliability of CPM with suprathreshold electrical pain detection threshold stimulation [ Time Frame: two minutes after the cold pressor test ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Reliability
The same testing procedure is repeated after a delay of 7 days to test the reliability of the measure
Device: Conditioned Pain Modulation
Measure of the conditioned pain modulation with the nociceptive withdrawal reflex and ice water stimulation
Device: Conditioned Pain Modulation
Suprathreshold electrical stimulation with 1.5 times the mean electrical pain detection threshold

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male Gender
  • Age 18-65
  • Signed Informed Consent

Exclusion Criteria

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636440

Locations
Switzerland
Dep. of Anesthesiology and Pain Medicine, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Aalborg University
Investigators
Study Director: Michele Curatolo, MD University Hosptial Bern
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01636440     History of Changes
Other Study ID Numbers: 070/12, SNF: SPUM 33CM30_124117
Study First Received: July 5, 2012
Last Updated: January 18, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Conditioned Pain Modulation

ClinicalTrials.gov processed this record on November 23, 2014