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The Effects of Water Temperature on the Cold Pressor Test

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ClinicalTrials.gov Identifier: NCT03083626
Recruitment Status : Completed
First Posted : March 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Brief 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.

Condition or disease Intervention/treatment
Chronic Pain Other: Cold pressor test

Detailed Description:

Since the 1940s, the cold pressor test (CPT) has been used experimentally as a pain induction method due to its reliability, cost effectiveness and minimal production of side effects. In the CPT, a patient is asked to place his or her hand and forearm in an ice bath until the pain is too great to remain in the water. Researchers have employed the CPT to test a wide range of pain management techniques, including medications, cognitive- based therapies, or acupuncture, as well as to explore pain perception. The CPT has been performed on a variety of participants, including adolescents, drug abusers, and those suffering from chronic back pain.

In their classic 1989 paper, Walsh and colleagues developed the normative model of the CPT demonstrating that variations in response are dependent upon age, sex and ethnicity. In 2004, however, Mitchell et al. discovered that the water temperature of the CPT also plays a crucial role in the pain tolerance time of the subjects, noting that a temperature variation of 4°C produced significantly different results for the same subject. While the Mitchell investigations improved upon the standard for the proper CPT technique, as seen implemented in the works of Rash and Campbell, their discoveries were based on healthy individuals.

Researchers have explored the CPT responses of patients with an altered pain perception, such as patients with Opioid-Induced Hyperalgesia (OIH), in comparison to healthy controls, demonstrating greater sensitivity in OIH patients. What has not been studied is the effect of temperature on CPT response in OIH patients. Further, the CPT has been shown to have a relatively lengthy recovery time averaging around 10 minutes; however, the recovery time for hypersensitive patients, such as OIH patients, has yet to be studied.

As an extension of the work of Mitchell and colleagues, the proposed research will assess the effects of temperature difference and recovery time of the CPT on patients with OIH in comparison to healthy normal control patients. This work is a sub-study of a larger study, Opioid-Induced Hyperalgesia In Prescription Opioid Abusers: Effects of Pregabalin (PRO00000669), conducted by principal investigator Dr. Peggy Compton. The goal of the parent study is to evaluate the ability of pregabalin to diminish chronic low back or arthritic pain and OIH in a sample of prescription opioid abusers (POAs) opioid therapy. This current study is not assigning specific interventions to study subjects. Healthy control and OIH participants will complete all study measures in a single two-hour study session.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Effects of Water Temperature on the Cold Pressor Test in Patients With Opioid-Induced Hyperalgesia in Comparison to Healthy Controls
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prescription opioid abusers
Patients 21-65 years old taking suboxone or methadone, currently experiencing chronic pain, not taking any opioid analgesic medication for painful condition on a regular basis, not have any current psychiatric or neurological illnesses, not have a history of heart disease in order to be healthy enough to complete the cold pressor test.
Other: Cold pressor test
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.

Healthy control participants
Patients 21-65 years old not taking suboxone or methadone, not experiencing chronic pain, not taking any opioid analgesic medication for painful condition on a regular basis, not have any current psychiatric or neurological illnesses, not have a history of heart disease in order to be healthy enough to complete the cold pressor test.
Other: Cold pressor test
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.




Primary Outcome Measures :
  1. Improved Pain Threshold Response [ Time Frame: 1 two-hour study session ]
    In a well-described sample of prescription opioid abusers and healthy control subjects, the cold pressor test will be administered to examine how long it takes for a subject to start feeling pain when they immerse their forearm in the cold water (measured in seconds).

  2. Improved Pain Tolerance Response [ Time Frame: 1 two-hour study session ]
    In a well-described sample of prescription opioid abusers and healthy control subjects, the cold pressor test will be administered to examine how long subjects' can withstand feeling pain when they immerse their forearm in the cold water (measured in seconds).

  3. Improved Pain Recovery Response [ Time Frame: 1 two-hour study session ]
    In a well-described sample of prescription opioid abusers and healthy control subjects, the cold pressor test will be administered to examine how long it takes for subjects' to recover from the pain they experienced when they had their forearm immersed in the cold water (measured in seconds).



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 10 prescription opioid abusers with chronic low back or arthritis pain and stable on opioid therapy (on methadone or buprenorphine) will be enrolled in the study. Meeting the same inclusion exclusion criteria of the prescription opioid abusers (except treatment methadone or buprenorphine), a total of 20 male and female healthy controls will be recruited.
Criteria

Inclusion Criteria:

  • Between 21 and 65 years old
  • On suboxone or methadone for at least ten days
  • Currently experiencing chronic low back or arthritis pain

Exclusion Criteria:

  • Be on any opioid analgesic
  • Have a neurological or psychiatric illness (i.e., schizophrenia, Raynaud's disease, urticaria, stroke) that would affect pain responses
  • Have an abnormal screening EKG, history of heart disease, stroke, liver or kidney disease or acute hepatitis, or currently have a pacemaker or uncontrolled high blood pressure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083626


Locations
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United States, District of Columbia
Georgetown University Medical Center
Washington, D.C., District of Columbia, United States, 20057
Sponsors and Collaborators
Georgetown University

Publications:
Ahles, T. A., Blanchard, E. B., &Leventhal, H. (1983). Cognitive control of pain: Attention to the sensory aspects of the cold pressor stimulus. Cognitive Therapy and Research, 7(2), 159-177.
Edens, J. L., & Gil, K. M. (1995). Experimental induction of pain: Utility in the study of clinical pain. Behavior Therapy, 26(2), 197-216.

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT03083626     History of Changes
Other Study ID Numbers: 2014-1378
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georgetown University:
Chronic pain
Narcotic abuse
Opioid related disorders
Opiate substitution treatment
Buprenorphine
Pregabalin
Methadone
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Methadone
Vasoconstrictor Agents
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents