Remote Ischemic Preconditioning Mechanism Study
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/12/2018 |
| Start Date: | March 2012 |
| End Date: | April 30, 2017 |
Remote Ischemic Preconditioning Effects on Central and Peripheral Sensitization in Healthy Volunteers-A Pilot Study
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.
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.
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.
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.
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.
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