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Remote Ischemic Preconditioning Mechanism Study

Information source: Wake Forest Baptist Health
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Remote Ischemic Preconditioning, Capsaicin, UV-B (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Wake Forest Baptist Health

Official(s) and/or principal investigator(s):
Scott A Miller, MD, Principal Investigator, Affiliation: Wake Forest Baptist Health

Overall contact:
Scott A Miller, MD, Phone: 336-716-4498, Email: scmiller@wfubmc.edu


This research is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications. Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several unanswered questions about how it works. This research trial will help determine how RIPC may activate the bodies natural pain control system. The goals of this study are to see if RIPC has any effect 1) on a small area of skin that will be expose to a small amount of UV- B radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the active ingredient in hot chili peppers) on skin. Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.

Clinical Details

Official title: Remote Ischemic Preconditioning Effects on Central and Peripheral Sensitization in Healthy Volunteers-A Pilot Study

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Areas of hyperalgesia and allodynia to mechanical stimuli.

Secondary outcome:

Pain intensity and unpleasantness to mechanical stimuli

Presence of parathesias where RIPC was used

Detailed description: The purpose of this pilot study is to determine whether RIPC effects peripheral sensitization, central sensitization or both and determine effect size since there is no data regarding the presumed effect. These issues cannot be easily sorted out in patients experiencing postoperative pain and hypersensitivity, since surgery affects both components. In order to address this purpose the investigators will examine, in healthy volunteers, the effect of RIPC on a manipulation which generates hypersensitivity by an exclusive peripheral mechanism (ultraviolet B (UV-B) burn) and a manipulation which generates hypersensitivity by an exclusive central mechanism (topical capsaicin). Understanding the sites at which RIPC reduces the amplification of pain after injury will be useful in determining where it would be most logically applied clinically and in guiding preclinical mechanistic studies.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- healthy volunteers of both sexes ASA 1 or II classification

- between the ages of 18-55

- weighing less than 250 pounds

- without chronic pain

- not taking analgesics

- off caffeine for 2 days.

Exclusion Criteria:

- pregnancy

- allergy to capsaicin

- lower extremity vascular insufficiency

- active treatment for DVT

- severe thigh pain

- taking psychotropic medications, including anti-depressants.

Locations and Contacts

Scott A Miller, MD, Phone: 336-716-4498, Email: scmiller@wfubmc.edu

WakeForestUBMC, Winston Salem, North Carolina 27157, United States; Recruiting
Scott A Miller, MD, Phone: 336-716-4498, Email: scmiller@wfubmc.edu
Scott A Miller, MD, Principal Investigator
Additional Information

Starting date: March 2012
Last updated: December 8, 2014

Page last updated: August 20, 2015

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