The Effects of Water Temperature on the Cold Pressor Test

NCT03083626 | Completed

• 1 other identifier: 2014-1378
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain; Narcotic abuse; Opioid related disorders; Opiate substitution treatment; Buprenorphine; Pregabalin; Methadone

Outcome Measures

Primary Outcomes (3)

• Improved Pain Threshold Response

  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).

  1 two-hour study session

• Improved Pain Tolerance Response

  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).

  1 two-hour study session

• Improved Pain Recovery Response

  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).

  1 two-hour study session

Study Arms (2)

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

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

Interventions

Cold pressor test OTHER

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; Prescription opioid abusers

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

Related Publications (15)

• 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.

  BACKGROUND

• Bellar D, Kamimori GH, Glickman EL. The effects of low-dose caffeine on perceived pain during a grip to exhaustion task. J Strength Cond Res. 2011 May;25(5):1225-8. doi: 10.1519/JSC.0b013e3181d9901f.

  PMID: 21522070 BACKGROUND

• Brands AEF, Schmidt AJM. Learning processes in the persistence behavior of chronic low back pain patients with repeated acute pain stimulation. Pain. 1987 Sep;30(3):329-337. doi: 10.1016/0304-3959(87)90021-2.

  PMID: 2959899 BACKGROUND

• Chang YP, Compton P. Management of chronic pain with chronic opioid therapy in patients with substance use disorders. Addict Sci Clin Pract. 2013 Dec 16;8(1):21. doi: 10.1186/1940-0640-8-21.

  PMID: 24341916 BACKGROUND

• Chu LF, Clark DJ, Angst MS. Opioid tolerance and hyperalgesia in chronic pain patients after one month of oral morphine therapy: a preliminary prospective study. J Pain. 2006 Jan;7(1):43-8. doi: 10.1016/j.jpain.2005.08.001.

  PMID: 16414554 BACKGROUND

• Compton MA. Cold-pressor pain tolerance in opiate and cocaine abusers: correlates of drug type and use status. J Pain Symptom Manage. 1994 Oct;9(7):462-73. doi: 10.1016/0885-3924(94)90203-8.

  PMID: 7822886 BACKGROUND

• Compton P. Pain tolerance in opioid addicts on and off naltrexone pharmacotherapy: a pilot study. J Pain Symptom Manage. 1998 Jul;16(1):21-8. doi: 10.1016/s0885-3924(98)00035-9.

  PMID: 9707654 BACKGROUND

• Edens, J. L., & Gil, K. M. (1995). Experimental induction of pain: Utility in the study of clinical pain. Behavior Therapy, 26(2), 197-216.

  BACKGROUND

• Hellstrom B, Lundberg U. Pain perception to the cold pressor test during the menstrual cycle in relation to estrogen levels and a comparison with men. Integr Physiol Behav Sci. 2000 Apr-Jun;35(2):132-41. doi: 10.1007/BF02688772.

  PMID: 11021338 BACKGROUND

• Lee M, Silverman SM, Hansen H, Patel VB, Manchikanti L. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011 Mar-Apr;14(2):145-61.

  PMID: 21412369 BACKGROUND

• Mitchell LA, MacDonald RA, Brodie EE. Temperature and the cold pressor test. J Pain. 2004 May;5(4):233-7. doi: 10.1016/j.jpain.2004.03.004.

  PMID: 15162346 BACKGROUND

• Pomerleau OF, Turk DC, Fertig JB. The effects of cigarette smoking on pain and anxiety. Addict Behav. 1984;9(3):265-71. doi: 10.1016/0306-4603(84)90018-2.

  PMID: 6496202 BACKGROUND

• Radtke T, Eser P, Kriemler S, Saner H, Wilhelm M. Adolescent blood pressure hyperreactors have a higher reactive hyperemic index at the fingertip. Eur J Appl Physiol. 2013 Dec;113(12):2991-3000. doi: 10.1007/s00421-013-2735-3.

  PMID: 24077645 BACKGROUND

• Walsh NE, Schoenfeld L, Ramamurthy S, Hoffman J. Normative model for cold pressor test. Am J Phys Med Rehabil. 1989 Feb;68(1):6-11. doi: 10.1097/00002060-198902000-00003.

  PMID: 2917058 BACKGROUND

• Wolf S, Hardy JD. STUDIES ON PAIN. OBSERVATIONS ON PAIN DUE TO LOCAL COOLING AND ON FACTORS INVOLVED IN THE "COLD PRESSOR" EFFECT. J Clin Invest. 1941 Sep;20(5):521-33. doi: 10.1172/JCI101245. No abstract available.

  PMID: 16694857 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Narcotic-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 20, 2017
• Study Start: May 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)