PainEarly Phase 1NCT01541436
Remote Ischemic Preconditioning Mechanism Study
A Early Phase 1 study testing Remote Ischemic Preconditioning, Capsaicin, UV-B in people with Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Remote Ischemic Preconditioning, Capsaicin, UV-B
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 30 Apr 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- pregnancy
- allergy to capsaicin
- lower extremity vascular insufficiency
- active treatment for DVT
- severe thigh pain
- taking psychotropic medications, including anti-depressants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Remote Ischemic Preconditioning, Capsaicin, UV-B
- Keywords
- Remote Ischemic Preconditioning, Nociception, Central Sensitization, Peripheral Sensitization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin, UV-B, RIPC | Active comparator | Not described Receives: Device: Remote Ischemic Preconditioning, Capsaicin, UV-B |
| Capsaicin, UV-B | Sham comparator | Not described Receives: Device: Remote Ischemic Preconditioning, Capsaicin, UV-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
Pain intensity and unpleasantness to mechanical stimuli
Using a Visual Analog Sliding Scale the intensity and unpleasantness will be measured in centimeters.
Measured: 24 hours
Presence of parathesias where RIPC was used
After a brief tourniquet application I fully expect participants to have some degree of parasthesias. Using a standard rating scale I will record and report this.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott A Miller, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541436
- Sponsor's protocol ID
- 00019284
- Status last verified
- Aug 2018
- First submitted
- 3 Feb 2012
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning Effects on Central and Peripheral Sensitization in Healthy Volunteers-A Pilot Study
- ClinicalTrials.gov ID
- NCT01541436
- Acronym / sponsor ID
- 00019284
- Conditions
- Pain
- Keywords
- Remote Ischemic Preconditioning, Nociception, Central Sensitization, Peripheral Sensitization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- pregnancy
- allergy to capsaicin
- lower extremity vascular insufficiency
- active treatment for DVT
- severe thigh pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic Preconditioning, Capsaicin, UV-BThe 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. | Device | Capsaicin, UV-B, Capsaicin, UV-B, RIPC |
Primary outcome
Areas of hyperalgesia and allodynia to mechanical stimuli.
Time frame: 24 hours
Hyperalgesia will be measured with vonFrey fibers and allodynia will be measured with a cotton wisp. The area will be measured in cm2.
2 secondary outcomes
Pain intensity and unpleasantness to mechanical stimuli
Time frame: 24 hours
Presence of parathesias where RIPC was used
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott A Miller, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Remote Ischemic Preconditioning, Capsaicin, UV-B in people with Pain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Areas of hyperalgesia and allodynia to mechanical stimuli. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.