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

Universidad Vina del Mar

Status: Completed

Conditions: Contraceptive Usage; Diffuse Noxious Inhibitory Control

Treatments: Other: Oral contraceptive (OC); Device: Mechanical stimulus; Other: No oral contraceptive (No OC); Procedure: Thermal (cold) stimulus

Study type: Interventional

Funder types: Other

Identifiers

NCT04365426

1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Oral contraceptive (OC)

Experimental group

Description:

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

Treatment:

Procedure: Thermal (cold) stimulus

Device: Mechanical stimulus

Other: Oral contraceptive (OC)

No oral contraceptive (No OC)

Experimental group

Description:

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

Treatment:

Other: No oral contraceptive (No OC)

Procedure: Thermal (cold) stimulus

Device: Mechanical stimulus