Primary Dysmenorrhea and Osteopathic Treatment

Escuela de osteopatía de Madrid

Status: Unknown

Conditions: Pelvic Pain; Sexual Dysfunction; Pelvic Pain Syndrome

Treatments: Other: Control Group; Other: Experimental Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04910672

OsteopatiaMadrid

MCLozano (Other Identifier)

Details and patient eligibility

About

This study is adressed to women with primary dysmenorrhea, it´s a gynecological disorder that is defined as colicky pain associated with menstruation and is located in the lower abdomen and in the lumbo-pelvic area. It appears between the first 8-72 hours and four days of the menstrual cycle and affects almost 85% of women, 30% of them severely. This study aims to demonstrate that osteopathic manual therapy is an effective therapeutic option in patients with primary dysmenorrhea. Another objective is to verify that osteopathic manual treatment provides an improvement in the intensity of pain, quality of life and a reduction in the consumption of medicines in these patients.

Full description

It will be a prospective study, a double-blind randomized controlled clinical trial. The sample group will include 60 patients, between 18 and 30 years old divided into two experimental groups. The experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manupulation (GPM) and a specific internal technique for mobility of the cervix, and the control group (n = 30) will only carry out a bilateral GPM. A measurement will be made before the first treatment, another after each session, and the last one two weeks after the last intervention (anthropometric measurements, quality of life questionnaire, sexual health, osteopathic tests, pressure point with algometer, pain and medicines consumption). The established outcome measures are: pain intensity according to the visual analog scale (VAS), depression points measured with an algometer, a health-related quality of life questionnaire, questionnaire sexual health and sexual dysfunctions, and the measurement of drug consumption.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Crampy pain in the lower abdomen or lumbo-pelvic area between 8 hours and 4 days after menstrual bleeding.
• Clinical evolution of at least three menstrual cycles with said pathology.
• Moderate menstrual pain or severe intensity, minimum 5 VAS scale.
• Regular menstrual cycle, between 21 and 35 days.
• Accept informed consent.

Exclusion criteria

• Being receiving any other physiotherapeutic or pharmacological treatment for primary dysmenorrhea during the 3 weeks prior to the beginning of the intervention.
• Suffering from cardiovascular diseases, prolapse, amenorrhea, hemophilia, tumor or infectious processes, use of IUDs, consumption of oral contraceptives or suffering from any injury that affects the sensory-motor function.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control Group

Active Comparator group

Description:

The control group (n = 30) will only carry out a bilateral global pelvic manipulation

Treatment:

Other: Control Group

Experimental Group

Experimental group

Description:

The experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manipulation and a specific internal technique for mobility of the cervix

Treatment:

Other: Experimental Group