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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?


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT01621620
Study type Interventional
Source Tel-Aviv Sourasky Medical Center
Contact Lior Dayan, M.D
Phone 972-50-4051014
Email liordayan.3105@gmail.com
Status Not yet recruiting
Phase N/A
Start date August 2012
Completion date August 2014

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