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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-24

Study Completion Date

2021-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Contraceptive Usage Diffuse Noxious Inhibitory Control

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Oral contraceptive (OC)

Oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.

Group Type EXPERIMENTAL

Mechanical stimulus

Intervention Type DEVICE

Electrical dynamometer to measure mechanical pressure

Thermal (cold) stimulus

Intervention Type PROCEDURE

Water cold bath

Oral contraceptive (OC)

Intervention Type OTHER

Oral contraceptive (OC)

No oral contraceptive (No OC)

No oral contraceptive patients will be tested to mechanical (cephalic and extracephalic) stimulus and cold pain stimulus.

Group Type EXPERIMENTAL

Mechanical stimulus

Intervention Type DEVICE

Electrical dynamometer to measure mechanical pressure

Thermal (cold) stimulus

Intervention Type PROCEDURE

Water cold bath

No oral contraceptive (No OC)

Intervention Type OTHER

No oral contraceptive (No OC)

Interventions

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Mechanical stimulus

Electrical dynamometer to measure mechanical pressure

Intervention Type DEVICE

Thermal (cold) stimulus

Water cold bath

Intervention Type PROCEDURE

Oral contraceptive (OC)

Intervention Type OTHER

No oral contraceptive (No OC)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes