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Completed

NCT Number: NCT03593057

Effectiveness of Manual Therapy in Dysmenorrhea

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.

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Key information

Conditions

Dysmenorrhea Primary Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy, Valencia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual therapy

Other

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

Control Group

Other

Advice on self-care and body awareness.

Primary outcomes

  1. 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

  1. SF-36 quality of life scale.

    Time frame: 9 weeks

    It consists of 36 items with the following scales: Physical function (items 3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h, 3i, 3j), Physical role (items 4a, 4b, 4c, 4d), Corporal pain ( items 7, 8), General Health (items 1, 11a, 11b, 11c, 11d), Vitality (items 9a, 9e, 9g, 9i), Social function (items 6, 10), Emotional role (items 5a, 5b, 5c) and Mental Health (items 9b, 9c, 9d, 9f, 9h). Includes an item on the change in the general health status with respect to the previous year (item 2). To calculate the score, we must first homogenize the address of the answers by re-coding the items that require it, so that "the higher the score, the better the health condition", then the calculation of the sum of the items of each scale and, finally, the linear transformation of raw scores on a scale of 0 (worst health status for that dimension) to 100 (the best health status).

  2. Global Impression Change Scale.

    Time frame: 9 weeks

    To assess the change perceived after the treatment, patients are asked to rate their perception of change in the Global Impression Change Scale of the patient, and a questionnaire with a question and 7 alternatives, being 1 "maximum change" and 7 "Nothing of change".

  3. Body Satisfaction and global self-perception Questionnaire.

    Time frame: 9 weeks

    It contains 10 positive and 10 negative adjectives about the participant's body sensation with alternative answers ranging from 1 = Excellent to 5 = Poor. Each question is scored independently.

  4. McGill pain perception questionnaire.

    Time frame: 9 weeks

    This questionnaire assesses quantitative and qualitative aspects of pain, such as location, quality, temporal properties and intensity.

    We use the short version, which consists of several clearly differentiated parts: Quality of pain that define the one with 66 words grouped into several categories that in turn form four large groups, pain assessment index (PRI): total and for each of the four areas (PRI), sensory, emotional PRI, valued PRI and miscellaneous PRI). The score is calculated adding that of each group of words that make up each category; b) Number of words chosen (NWC): sum of the number of pain characteristics selected by the patient; c) Pain intensity index (PPI): selected response of the item that explores this aspect.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Effectiveness of a Manual Therapy Protocol in Women With Dysmenorrhea

Acronym: MTDysmen

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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