NCT01636440

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

July 5, 2012

Last Update Submit

January 18, 2013

Conditions

Keywords

Conditioned Pain Modulation

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

OTHER

The same testing procedure is repeated after a delay of 7 days to test the reliability of the measure

Device: Conditioned Pain Modulation

Interventions

Measure of the conditioned pain modulation with the nociceptive withdrawal reflex and ice water stimulation

Reliability

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Dep. of Anesthesiology and Pain Medicine, Bern University Hospital

Bern, 3010, Switzerland

Location

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.

Study Officials

  • Michele Curatolo, MD

    University Hosptial Bern

    STUDY DIRECTOR

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

Locations