CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Cold pressor testother
Likely dose
Not stated in record
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Search/NCT03083626
NCT03083626N/ACompleted

The Effects of Water Temperature on the Cold Pressor Test in Patients With Opioid-Induced Hyperalgesia in Comparison to Healthy Controls

Georgetown University·observational·Posted Mar 20, 2017·Updated Apr 20, 2017

In Brief

An observational study evaluating Cold pressor test for Chronic Pain. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This current study is intended to be completed under the umbrella of the current GHUCCTS IRB- approved study "Opioid-Induced Hyperalgesia In Prescription Opioid Abusers: Effects of Pregabalin" (Lyrica study) (PRO00000669). In this proposed study, 10 healthy male, 10 healthy female participants and 5 male, 5 female OIH participants (from the parent Lyrica study), who are prescription opioid abusers with chronic pain currently taking Suboxone, will be asked to take the cold pressor test at 1, 5, and 9 degrees Celsius and to report the time at which pain has completely gone away following each test. The purpose of this study is to examine how the water temperature of the cold pressure test might affect the participants' response (i.e., the participants pain threshold and pain tolerance) and to see if there is a difference in how each participation group is affected.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 20, 2017
Enrollment StartMay 1, 2015
Primary CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.3 years ago

Interventions

Cold pressor testother

The cold pressor test is a procedure used for examining pain threshold and tolerance by subjects placing their forearm in an ice bath. Each participant will take the CPT at 1 °C, 5°C, and 9°C. The first CPT will always be at 1 °C, to ensure participants tolerate the ice bath at the standard temperature. The order of the subsequent CPT at 5°C and 9°C, will be randomized to control for differential carry over effects. Participants will be instructed to say "Pain" when pain is initially detected (threshold). Then they will be asked to keep the immersed limb in the container until the pain can no longer be tolerated and say "Stop" and remove the arm from the water when tolerance is reached.