NCT01541436

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for early_phase_1 pain

Timeline
Completed

Started Mar 2012

Longer than P75 for early_phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

4 years

First QC Date

February 3, 2012

Last Update Submit

August 8, 2018

Conditions

Pain

Keywords

Remote Ischemic PreconditioningNociceptionCentral SensitizationPeripheral Sensitization

Outcome Measures

Primary Outcomes (1)

  • Areas of hyperalgesia and allodynia to mechanical stimuli.

    Hyperalgesia will be measured with vonFrey fibers and allodynia will be measured with a cotton wisp. The area will be measured in cm2.

    24 hours

Secondary Outcomes (2)

  • Pain intensity and unpleasantness to mechanical stimuli

    24 hours

  • Presence of parathesias where RIPC was used

    24 hours

Study Arms (2)

Capsaicin, UV-B, RIPC

ACTIVE COMPARATOR
Device: Remote Ischemic Preconditioning, Capsaicin, UV-B

Capsaicin, UV-B

SHAM COMPARATOR
Device: Remote Ischemic Preconditioning, Capsaicin, UV-B

Interventions

Remote Ischemic Preconditioning, Capsaicin, UV-BDEVICE

The participants will have one disposable tourniquet applied to the left mid thigh by research personnel. The participants will then be randomized to the treatment group or sham group. The treatment group will receive 3 cycles of RIPC to the left lower leg by occluding blood flow at the thigh with a pneumatic cuff. Each cycle will consist of 5 minutes of ischemia by inflating the cuff to 300 mmHg followed by 5 minutes of reperfusion. The sham group will have the cuff inflated to no more than 15mmHg for three cycles as described above. Areas of hypersensitivity and allodynia will be obtained every 40 min for 280 min following the end of capsaicin application.

Capsaicin, UV-BCapsaicin, UV-B, RIPC

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnancy
  • allergy to capsaicin
  • lower extremity vascular insufficiency
  • active treatment for DVT
  • severe thigh pain
  • taking psychotropic medications, including anti-depressants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WakeForestUBMC

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Scott A Miller, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2012

First Posted

March 1, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2016

Study Completion

April 30, 2017

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)