Effectiveness of Manual Therapy in Dysmenorrhea

NCT ID: NCT03593057

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-05

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Dysmenorrhea Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Manual therapy protocol

Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, (at the beginning, at 2 weeks and at 3 weeks).

Group Type EXPERIMENTAL

Control group

Intervention Type OTHER

Advice on self-care and body awareness.

Control group.

Advice on self-care and body awareness.

Group Type ACTIVE_COMPARATOR

Manual therapy

Intervention Type OTHER

Manual therapy protocol and self-care advice and body awareness.

Interventions

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Manual therapy

Manual therapy protocol and self-care advice and body awareness.

Intervention Type OTHER

Control group

Advice on self-care and body awareness.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physiotherapy

Valencia, , Spain

Site Status

Gemma V Espí López

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ID0023

Identifier Type: -

Identifier Source: org_study_id

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