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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01621620
• Other study ID #: TASMC-12-JG-0044-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 3, 2012
• Last updated: June 15, 2012
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: June 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Lior Dayan, M.D
• Phone: 972-50-4051014
• Email: liordayan.3105[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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.

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?

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Yohimbine

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center, Pain Medicine Unit	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No