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Effectiveness of Manual Therapy in Dysmenorrhea (MTDysmen)

Primary Purpose

Dysmenorrhea Primary

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy
Control group
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dysmenorrhea Primary focused on measuring dysmenorrhoea, manual therapy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physiotherapy
  • Gemma V Espí López

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual therapy protocol

Control group.

Arm Description

Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, one every 15 days.

Advice on self-care and body awareness.

Outcomes

Primary Outcome Measures

Visual Analog Scale of Pain.
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 Outcome Measures

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

Full Information

First Posted
June 1, 2018
Last Updated
October 2, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03593057
Brief Title
Effectiveness of Manual Therapy in Dysmenorrhea
Acronym
MTDysmen
Official Title
Effectiveness of a Manual Therapy Protocol in Women With Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 control group. The study will last two months (2 menstrual cycles). Patients in the intervention group will receive 4 treatment sessions, 2 times the week before the first menstrual cycle, and 2 times a week during the second menstrual cycle, 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 every 15 days; Group 2 control. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea Primary
Keywords
dysmenorrhoea, manual therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy protocol
Arm Type
Experimental
Arm Description
Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, one every 15 days.
Arm Title
Control group.
Arm Type
Active Comparator
Arm Description
Advice on self-care and body awareness.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
Manual therapy protocol and self-care advice and body awareness.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Advice on self-care and body awareness.
Primary Outcome Measure Information:
Title
Visual Analog Scale of Pain.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
SF-36 quality of life scale.
Description
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).
Time Frame
8 weeks
Title
Global Impression Change Scale.
Description
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".
Time Frame
8 weeks
Title
Body Satisfaction and global self-perception Questionnaire.
Description
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.
Time Frame
8 weeks
Title
McGill pain perception questionnaire.
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with dysmenorrhoea
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Physiotherapy
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Gemma V Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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Effectiveness of Manual Therapy in Dysmenorrhea

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