Clinical trial NCT03593057: Effectiveness of Manual Therapy in Dysmenorrhea
Official title: Effectiveness of a Manual Therapy Protocol in Women With Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea Primary
Keywords: dysmenorrhoea
manual therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Visual Analog Scale of Pain.
timeFrame: 9 weeks
Secondary outcomes:
measure: SF-36 quality of life scale.
timeFrame: 9 weeks
measure: Global Impression Change Scale.
timeFrame: 9 weeks
measure: Body Satisfaction and global self-perception Questionnaire.
timeFrame: 9 weeks
measure: McGill pain perception questionnaire.
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy
city: Valencia
country: Spain
facility: Gemma V Espí López
Study officials:
References: