Effects of Oral Contraceptives on DNIC in Non-painful Healthy Women

Universidad Vina del Mar50 enrolled

Overview

The purpose of this study is tu assess the influence of oral contraceptives (OC) on diffuse noxious inhibitory control (DNIC) in healthy women, tested during high, low endogenous estrogens sessions and ovulatory period.

After being informed about the study and it protocol, all patients giving written informed consent, will undergo to a cephalic (masseter) and extracephalic (finger) mechanical stimulus to evaluate the threshold of mechanical pain, and physiological records of systolic/diastolic pressure and heart rates. After, we will evaluate the threshold response and physiological rates to the same mechanical stimulus under a thermal (cold) conditional pain (TCP) at 3 different moments of menstrual period in No contraceptive group (No OC) versus Contraceptive group (CO). Finally, we will compare the mechanical threshold response, physiological rates and pain perception between both groups.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Contraceptive Usage Diffuse Noxious Inhibitory Control

Interventions

Mechanical stimulusDEVICE

Electrical dynamometer to measure mechanical pressure

Thermal (cold) stimulusPROCEDURE

Water cold bath

Oral contraceptive (OC)OTHER

Oral contraceptive (OC)

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy women with oral contraceptive treatment (for at least 3 consecutive months), greater than or equal to 15 years old. * Healthy women without oral contraceptive treatment, greater than or equal to 15 years old. * Non pregnant women. * Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments * Without systemic pathologies. Exclusion Criteria: * Treatment of a pain, depression, hypertension, convulsion condition with or without medication. * Regular use of benzodiazepines. * Systemic pathologies * Pregnant women * Menopausal women

Locations (1)

Universidad Viña del Mar

Viña del Mar, Región de Valparaíso, Chile

Outcomes

Primary Outcomes

Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy women

The efficiency of diffuse noxious inhibitory control (DNIC) is a measure of one's ability to inhibit pain perception. DNIC efficiency is assessed by a psychophysical test that involves a mechanical pressure in the masseter (cephalic) and finger (extracephalic) stimulus as the "test stimulus" and a cold-water bath as the "conditioning stimulus". The results of this test will be used as the primary outcome measure.

Time frame: Baseline phase 1 (2-5 days), phase 2 (14-17 days), and phase 3 (21-27 days) after the beginning of menstrual period

Data from ClinicalTrials.gov

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