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The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01621620
Recruitment Status : Unknown
Verified June 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 18, 2012
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief 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.

study questions

The study questions are derived from the study objectives:

  1. Does sympatho-vagal balance influence pain perception?
  2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
  3. Does sympatho-vagal balance influence temporal summation?
  4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?

Condition or disease Intervention/treatment Phase
Pain Drug: Yohimbine Not Applicable

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

  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.

2.c study questions

The study questions are derived from the study objectives:

  1. Does sympatho-vagal balance influence pain perception?
  2. Does sympatho-vagal balance influence diffuse noxious inhibitory control systems?
  3. Does sympatho-vagal balance influence temporal summation?
  4. Does the hypoalgesic effect to acute increase in blood pressure a result of baroreflex activation?

3. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: yohimbin Drug: Yohimbine



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621620


Contacts
Contact: Lior Dayan, M.D 972-50-4051014 liordayan.3105@gmail.com

Locations
Israel
Tel Aviv Sourasky Medical Center, Pain Medicine Unit Not yet recruiting
Tel Aviv, Israel
Contact: Lior Dayan, M.D    972-50-4051014      
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Giris jacob, MD Tel-Aviv Sourasky Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01621620     History of Changes
Other Study ID Numbers: TASMC-12-JG-0044-CTIL
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Yohimbine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents