Clinical trial NCT04910672: Primary Dysmenorrhea and Osteopathic Treatment
Official title: Effectiveness of Osteopathic Treatment in Patients With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Pain
Pelvic Pain Syndrome
Sexual Dysfunction
Keywords: Primary Dysmenorrhea
Spinal Manipulation
Pelvic Pain
Pain Threshold
Sexual Dysfunctions
Osteopathic Treatment
Manual therapy
Visceral Manipulation
Lead sponsor: Escuela de osteopatía de Madrid
Sponsor class: OTHER
Collaborators: name: University of Seville
First posted: 2021-06-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind prospective, longitudinal, randomized, controlled clinical trial.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the Visual Analogue Scale (pain) during menstruation at week 4, 8 and 10.
timeFrame: Baseline and week 4, 8 and 10
measure: Change from Baseline in the Specific Quality of Life Questionnaire Related to Menstruation CVM-22 at weeks 4, 8 and 10
timeFrame: Baseline and weeks 4, 8 and 10
measure: 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
timeFrame: Baseline and weeks 4, 8 and 10
measure: change from baseline in the values of the pressure algometer measured on 9 different points at weeks 4, 8 and 10.
timeFrame: Pre-intervention and post-intervention in Baseline and weeks 4 and 8. Another measure without intervention in week 10.
measure: Change from baseline in Medication intake during the menstrual period at weeks 4, 8 and 10.
timeFrame: Baseline and weeks 4, 8 and 10
Secondary outcomes:
Other outcomes:
Locations:
city: Arcos de la Frontera
country: Spain
facility: Miriam Corona Lozano
state: Cádiz
Study officials:
affiliation: Escuela Osteopatía Madrid
name: François Ricard, DO
role: STUDY_DIRECTOR
References: