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Clinical Trials/NCT03593057
NCT03593057
Completed
Not Applicable

Effectiveness of a Manual Therapy Protocol in Women With Dysmenorrhea

University of Valencia2 sites in 1 country39 target enrollmentJune 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysmenorrhea Primary
Sponsor
University of Valencia
Enrollment
39
Locations
2
Primary Endpoint
Visual Analog Scale of Pain.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The objective of this clinical study would be to verify if manual therapy is effective in the treatment to reduce pain in women suffering from primary dysmenorrhea.

Material and methods In this experimental study, women diagnosed with primary dysmenorrhea will be included, which will be divided randomly into two groups: an intervention group and a comparator group.

The study will last nine weeks (3 menstrual cycles). Patients in the intervention group will receive 3 treatment sessions.

The evaluation will include pain, the quality of life, the global impression of change, personal body satisfaction and global self-perception and the pain perception.

Detailed Description

Introduction The prevalence of primary dysmenorrhoea is high and has an impact on quality of life, pain and disability. The cause is due to the increase of postaglandins that can be influenced by the lowering of progesterone. In short, there is a complex relationship between hormones and the immune system. Manual therapy increases the mobility of the sacrum and tissues of the pelvis, increasing the blood supply and the uterus that has parasympathetic innervation through the sacrum improves mobility, motility and irrigation. The ligaments, fasciae and tissue of the pelvis improve their irrigation through fascial, mobility and visceral techniques, which would improve uterine mobility by anatomical connections with these structures. With better mobility the uterus, and therefore the smooth muscle, would have more irrigation and less pain and hypercontractivility. The adjacent tissues, perineum, triangular ligament, innervated by the vagus nerve, improve The main objective is the improvement of quality of life, personal body satisfaction and overall self-perception and pain reduction in women with dysmenorrhea after treatment with manual therapy and provide information and advice on self-care and menstrual awareness. Methods Sample. The sample is formed by women with dysmenorrhoea aged between 18 and 45 years, with no other abdominopelvic problems. Design. The sample will be divided into 2 groups: Group 1. Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, (one at the beginning, another at 2 weeks and another at 3 weeks); Group 2 comparator. Advice on self-care and body awareness. Evaluations: * Clinical interview with anthropometric data and characteristics of the pathology (age, weight, height, pain characteristics) There will be 3 evaluations: Evaluation at the beginning, at the end of the treatment and a follow-up of one month. * SF-36 quality of life scale. * Visual Analog Scale (EVA). * Feeling of change after treatment with the Patient Global Impression of Change Scale. * Personal Body Satisfaction and Global Self-Perception. * McGill pain perception questionnaire.

Registry
clinicaltrials.gov
Start Date
June 5, 2018
End Date
August 31, 2018
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

University of Valencia

Eligibility Criteria

Inclusion Criteria

  • Women with menstrual pain of more than 6 months of evolution.
  • Women with pain equal to or greater than 4 on the visual analogue scale in more than half of their one-year menstrual cycles.

Exclusion Criteria

  • Hormone treatment
  • Contraindication to any of the treatments
  • Participate in this period of no functional recovery program or physiotherapy treatment.

Outcomes

Primary Outcomes

Visual Analog Scale of Pain.

Time Frame: 9 weeks

The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.

Secondary Outcomes

  • SF-36 quality of life scale.(9 weeks)
  • Global Impression Change Scale.(9 weeks)
  • Body Satisfaction and global self-perception Questionnaire.(9 weeks)
  • McGill pain perception questionnaire.(9 weeks)

Study Sites (2)

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