Primary Dysmenorrhea and Osteopathic Treatment

Sexual Dysfunction Clinical Trial

Official title:

Effectiveness of Osteopathic Treatment in Patients With Primary Dysmenorrhea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04910672
• Other study ID #: OsteopatiaMadrid
• Secondary ID: MCLozano
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: November 2021

Study information

• Verified date: May 2021
• Source: Escuela de osteopatía de Madrid
• Contact: Sara S Tello, PT
• Phone: 651458007
• Email: sara_santiago_tello[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Pelvic Pain
• Pelvic Pain Syndrome
• Sexual Dysfunction

Intervention

Other:
• Control Group
Bilateral global pelvic manipulation. Lower right limb in extension. The left lower limb in flexion, until the tension on the SPIS was felt. Introduce very little rotation of the spine. ASI anterior slide until crease forms at waist. We bring the elbow towards our hips. We rotate the patient posteriorly to open the lumbo sacral facet. The thrust is performed by simultaneously increasing these three parameters, with kick and joint compression.
• Experimental Group
Bilateral Global Pelvic Manipulation and Internal Correction Technique for Laterflexion of the Uterus The technique consists of making contact with the vaginal fingers on the upper and anterior part of the cervix, while the abdominal hand, dragging the skin towards the pubis, tries to make contact as posterior as possible on the fundus of the uterus. The technique consists, while the patient breathes widely, in progressively raising the uterine fundus forward and upward and lowering the cervix until the normal anteversion position is achieved. At the end of the technique, fixing the correction position of the uterus, we can ask the patient to perform a pelvic anteversion, while the correction is maintained. At the end of the technique, all abnormal tension should have disappeared and the uterus should have recovered a physiological position of anteversion.

Locations

Country	Name	City	State
Spain	Miriam Corona Lozano	Arcos de la Frontera	Cádiz

Sponsors (2)

Lead Sponsor	Collaborator
Escuela de osteopatía de Madrid	University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Visual Analogue Scale (pain) during menstruation at week 4, 8 and 10.	Measured before the treatment in each meeting, asking about the pain during the last menstrual period. The higher is the value of the scale, the worse.	Baseline and week 4, 8 and 10
Primary	Change from Baseline in the Specific Quality of Life Questionnaire Related to Menstruation CVM-22 at weeks 4, 8 and 10	The CVM-22, self-administered Likert type, is made up of 22 items. The questionnaire score ranges from 0 to 66, where the higher the score the worse the CVM-22.	Baseline and weeks 4, 8 and 10
Primary	Change from Baseline in the Questionnaire on sexual health and detection of female sexual dysfunctions in primary care (SyDSF-AP) at weeks 4, 8 and 10	Self-administered questionnaire of 20 closed questions, although 8, 9 and 19 have an open component, and 1 is an open question, which is integrated into domains. Those of the descriptive sociodemographic domain and the health condition help to know the profile of the surveyed women, as well as the factors that may influence their sexuality. The domain of sexual function ranges from question 10 to 18 and is answered using a Likert scale of 5 values. In addition, question 20 has been included to assess satisfaction with your partner from 0 to 10. Finally, question 21 is open to collect the comments that may arise during the completion of the questionnaire.	Baseline and weeks 4, 8 and 10
Primary	change from baseline in the values of the pressure algometer measured on 9 different points at weeks 4, 8 and 10.	The Pressure Threshold is defined as the minimum pressure that triggers a painful response. The WAGNER brand "FORCE TEN" pressure algometer was used to quantify the Pressure Thereshold at the 9 sensitive pressure points of dysmenorrhea. The rubber tip was used to focus the pressure exerted by the evaluator and it was placed perpendicular to each point. The measurements were carried out 3 times for each point (with 10 seconds of difference between each measurement, 30 before moving on to another point) and calculating the mean value. Before carrying out the measurements, the patients were instructed in the procedure, giving as an example an area not included in the assessment. When the pressure sensation started to be painful, they should tell the evaluator.	Pre-intervention and post-intervention in Baseline and weeks 4 and 8. Another measure without intervention in week 10.
Primary	Change from baseline in Medication intake during the menstrual period at weeks 4, 8 and 10.	The average consumption of NSAIDs by the dose of medication used, self-reported responses by the participants. It will be recorded in a journal that will be given to them to write down.	Baseline and weeks 4, 8 and 10