Clinical trial NCT01621620: The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects
Official title: The Role of Sympatho-vagal Balance on Different Limbs of Pain Perception in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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?

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).

Eligibility 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.

Primary outcomes:
measure: The role of sympatho-vagal balance on different limbs of pain perception in healthy subjects
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, Pain Medicine Unit
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Giris jacob, MD
role: PRINCIPAL_INVESTIGATOR
References: