PainNCT01621620
The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects
A study testing Yohimbine in people with Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
objectives 1. To study the sympatho-vagal balance effect on different limbs of pain perception. 2. To determine whether it is the hypertension by itself or the baroreflex activation due to blood pressure rise that is responsible for the analgesic effect of acute hypertension. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Yohimbine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females with no known medical conditions, neither taking any chronic medications.
- Ages between 20-50.
- Capable of reading and signing an informed consent.
Who cannot join
- Any known former medical condition by history affecting any system in the body:
- cardiovascular - any history of angina or chest pain, known valvular disease, known arrhythmia of any kind in the past.
- hypertension defined as SBP > 130 DBP > 90 and heart rate at rest > 90 BPM.
- any occlusive peripheral vascular disease (lower limbs' pulses TP, DP, popliteal and femoral pulses absence on physical examination on the first session).
- smoking.
- History of allergy to any drug.
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- Inability to understand the experiment procedure and sign an informed consent.
- Any history of severe trauma trauma to the limbs.
- Any history of neurologic or psychiatric disorder.
- Pregnancy or on anticonceptive pills.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center, Pain Medicine Unit
Tel Aviv
Lior Dayan, M.D, 972-50-4051014
About this study
objectives
- To study the sympatho-vagal balance effect on different limbs of pain perception.
- To determine whether it is the hypertension by itself or the baroreflex activation due to blood pressure rise that is responsible for the analgesic effect of acute hypertension. study questions
The study questions are derived from the study objectives:
- Does sympatho-vagal balance influence pain perception?
- Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
- Does sympatho-vagal balance influence temporal summation?
- Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?
Read the detailed description
Hypothesis
We hypothesize that the activation of the sympathetic system, which leads to increased hypertension, rather than the cholinergic response to increased BP, is responsible for antinociceptive effect of hypertension.
2.b objectives
- To study the sympatho-vagal balance effect on different limbs of pain perception.
- To determine whether it is the hypertension by itself or the baroreflex activation due to blood pressure rise that is responsible for the analgesic effect of acute hypertension.
2.c study questions
The study questions are derived from the study objectives:
- Does sympatho-vagal balance influence pain perception?
- Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
- Does sympatho-vagal balance influence temporal summation?
- Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?
- Subjects and methods
3.a subjects
Every subject will be invited to 2 separate sessions. At least 24 hours will apart the two sessions. The test in each session is described in details in the Hebrew protocol attached to the current protocol in English.
An informed consent will be signed by each subject prior to a thorough interview. The interview, composed of several question regarding prior health problems, current or past use of medications as well as demographic details (as detailed in the Hebrew protocol) will take place in the test room prior to the beginning of the first session.
Screening tests will include detailed interview, blood pressure, heart rate and ECG strip at the beginning of the first(but not the second) session. The first measurement will be taken following 15 minutes complete rest. The second and the third after 5 and 10 minutes, respectively. Blood examinations are not required in this study.
Healthy subjects: 20 age matched subjects (20-50).
- Conditions
- Pain
- Being tested
- Yohimbine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YohimbineDrug
| Study group | Role | What they receive |
|---|---|---|
| yohimbin | Experimental | Not described Receives: Drug: Yohimbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of sympatho-vagal balance on different limbs of pain perception in healthy subjects
The outcome will be the respose to tonic heat pain on a VAS scale from 0-100 (where 0 no pain and 100 worst pain imagined) before and after administration of drugs that afect the sympathetic nervous system.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2014 (estimated)
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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Giris jacob, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621620
- Sponsor's protocol ID
- TASMC-12-JG-0044-CTIL
- Status last verified
- Jun 2012
- First submitted
- 3 Jun 2012
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01621620
- Acronym / sponsor ID
- TASMC-12-JG-0044-CTIL
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 18 Jun 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.
objectives
- To study the sympatho-vagal balance effect on different limbs of pain perception.
- To determine whether it is the hypertension by itself or the baroreflex activation due to blood pressure rise that is responsible for the analgesic effect of acute hypertension. study questions
The study questions are derived from the study objectives:
- Does sympatho-vagal balance influence pain perception?
- Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
- Does sympatho-vagal balance influence temporal summation?
- Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?
Detailed description
Hypothesis
We hypothesize that the activation of the sympathetic system, which leads to increased hypertension, rather than the cholinergic response to increased BP, is responsible for antinociceptive effect of hypertension.
2.b objectives
- To study the sympatho-vagal balance effect on different limbs of pain perception.
- To determine whether it is the hypertension by itself or the baroreflex activation due to blood pressure rise that is responsible for the analgesic effect of acute hypertension.
2.c study questions
The study questions are derived from the study objectives:
- Does sympatho-vagal balance influence pain perception?
- Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
- Does sympatho-vagal balance influence temporal summation?
- Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?
- Subjects and methods
3.a subjects
Every subject will be invited to 2 separate sessions. At least 24 hours will apart the two sessions. The test in each session is described in details in the Hebrew protocol attached to the current protocol in English.
An informed consent will be signed by each subject prior to a thorough interview. The interview, composed of several question regarding prior health problems, current or past use of medications as well as demographic details (as detailed in the Hebrew protocol) will take place in the test room prior to the beginning of the first session.
Screening tests will include detailed interview, blood pressure, heart rate and ECG strip at the beginning of the first(but not the second) session. The first measurement will be taken following 15 minutes complete rest. The second and the third after 5 and 10 minutes, respectively. Blood examinations are not required in this study.
Healthy subjects: 20 age matched subjects (20-50).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| yohimbin | Experimental | Drug: Yohimbine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females with no known medical conditions, neither taking any chronic medications.
- Ages between 20-50.
- Capable of reading and signing an informed consent.
Key exclusion criteria (10 listed)
- Any known former medical condition by history affecting any system in the body:
- cardiovascular - any history of angina or chest pain, known valvular disease, known arrhythmia of any kind in the past.
- hypertension defined as SBP > 130 DBP > 90 and heart rate at rest > 90 BPM.
- any occlusive peripheral vascular disease (lower limbs' pulses TP, DP, popliteal and femoral pulses absence on physical examination on the first session).
- smoking.
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 |
|---|---|---|
| Yohimbine | Drug | yohimbin |
Primary outcome
The role of sympatho-vagal balance on different limbs of pain perception in healthy subjects
The outcome will be the respose to tonic heat pain on a VAS scale from 0-100 (where 0 no pain and 100 worst pain imagined) before and after administration of drugs that afect the sympathetic nervous system.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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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.
Giris jacob, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yohimbine in people with Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Jun 2012. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lior Dayan, M.D (972-50-4051014, liordayan.3105@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of sympatho-vagal balance on different limbs of pain perception in healthy subjects. 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 18 Jun 2012.