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

Not Applicable

Completed

• Conditions: Contraceptive Usage; Diffuse Noxious Inhibitory Control
• Interventions: Device: Mechanical stimulus; Procedure: Thermal (cold) stimulus; Other: Oral contraceptive (OC); Other: No oral contraceptive (No OC)

• Registration Number: NCT04365426
• Lead Sponsor: Universidad Vina del Mar

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-04-24
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Primary Completion: 2021-01-30
• Study Completion: 2021-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral contraceptive (OC)	Oral contraceptive (OC)	Oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.
No oral contraceptive (No OC)	Mechanical stimulus	No oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.
Oral contraceptive (OC)	Thermal (cold) stimulus	Oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.
No oral contraceptive (No OC)	No oral contraceptive (No OC)	No oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.
Oral contraceptive (OC)	Mechanical stimulus	Oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.
No oral contraceptive (No OC)	Thermal (cold) stimulus	No oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.

Primary Outcome Measures

Name	Time	Method
Diffuse Noxious Inhibitory Control Efficiency in oral contraceptive healthy women	Baseline phase 1 (2-5 days), phase 2 (14-17 days), and phase 3 (21-27 days) after the beginning of menstrual period	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.

Trial Locations

Locations (1)

Universidad Viña del Mar; 🇨🇱 Viña Del Mar, Valparaiso, Chile