The Effects of Water Temperature on the Cold Pressor Test

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083626
• Other study ID #: 2014-1378
• Status: Completed
• Phase: N/A
• First received: March 7, 2017
• Last updated: April 18, 2017
• Start date: May 1, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2017
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

References & 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.

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. — View Citation

Brands AM, Schmidt AJ. Learning processes in the persistence behavior of chronic low back pain patients with repeated acute pain stimulation. Pain. 1987 Sep;30(3):329-37. — View Citation

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;8:21. doi: 10.1186/1940-0640-8-21. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Hellström 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. — View Citation

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. Review. — View Citation

Mitchell LA, MacDonald RA, Brodie EE. Temperature and the cold pressor test. J Pain. 2004 May;5(4):233-7. — View Citation

Pomerleau OF, Turk DC, Fertig JB. The effects of cigarette smoking on pain and anxiety. Addict Behav. 1984;9(3):265-71. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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