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Trial registered on ANZCTR

Registration number

ACTRN12618000654257

Ethics application status

Approved

Date submitted

18/12/2017

Date registered

24/04/2018

Date last updated

30/11/2018

Date data sharing statement initially provided

30/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Changes in the perception of pain and menstrual symptoms in women with primary dysmenorrhoea with the technique of stretching the uterine ligaments externally

Scientific title

Changes in the perception of pain and menstrual symptoms in women with primary dysmenorrhoea with the technique of stretching the uterine ligaments externally

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1202-5462

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

primary dysmenorrhea

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Reproductive Health and Childbirth

Menstruation and menopause

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Brief name: Changes in the perception of pain and menstrual symptoms in women with primary dysmenorrhea with the technique of stretching the uterine ligaments externally.
-There are two study groups, one experimental group and one control group. In both the diagnostic and evaluation technique is the same, but they differ in the therapeutic technique. The duration of the intervention in both groups is the 15 minutes approximated. The treatment technique of the experimental group is the technique of stretching the uterine ligaments externally and the therapeutic technique of the control group is to apply an ultrasound turned off for 5 minutes ("placebo treatment") in the region of the uterus in the abdomen.
-The intervention will be performed by a physiotherapist and osteopath of more than 7 years of experience in a private practice and in a single session, the first day of one single menstrual cycle of women.
-The evaluation will be done by a physiotherapist with more than 7 years of experience, individually through written tests, and it will be through the Visual Analogue Scale (EVA) and the Menstrual Distress Questionnaire (MDQ). 5 measurements will be made: a measurement on the seventh day of two menstrual cycles before the intervention; a measurement on the seventh day of the menstrual cycle in which the treatment is performed; and a measurement on the seventh day of the two menstrual cycles after the intervention.
-To maintain fidelity the professionals who evaluate and treat will be different and the assignment of subjects will be done randomly,

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

The therapeutic technique of the control group is to apply an ultrasound turned off for 5 minutes ("no treatment") in the region of the uterus in the abdomen.

Control group

Placebo

Outcomes

Primary outcome [1]

Change in the presence, intensity and quantity of symptoms related to the menstrual cycle according to the MDQ (Menstrual Distress Questionnaire).

Timepoint [1]

In the following two menstrual cycles after manipulation (measurements 4 and 5 of the study), the seventh day of the cycle. That is to say, on day 7 of the 2 menstrual cycles post intervention with the primary outcome being on day 7 of the menstrual cycle immediately post-intervention.

Secondary outcome [1]

Change in the perception of pain through the Visual Analogue Scale (EVA).

Timepoint [1]

In the following two menstrual cycles after manipulation (step 4 and 5 of the study), the seventh day of the cycle. That is to say, on day 7 of the 2 menstrual cycles post intervention with the primary outcome being on day 7 of the menstrual cycle immediately post-intervention.

Eligibility

Key inclusion criteria

- Female gender
- Age between 18 and 50 years
- Diagnosis according to the Primary dysmenhorrea consensus guideline
- Normal menstrual cycle (28 + -7 days)
- Moderate or severe menstrual pain according to the Visual Analogue Scale (EVA) (45 to 74 mm, moderate pain, and 75 to 100 mm, severe pain)
-Subjects that gave informed consent

Minimum age

18 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

-Have an intrauterine device
-Women taking oral contraceptives
-Diagnostic secondary dysmenorrhea
- Previous gynecological interventions
-Contraindications for the manipulative technique
-Have received osteopathic treatment within two months before the start of the study
-Who shows stress or fear of manipulation

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

"Allocation is not concealed"

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

-The amount of the sample size is 60 patients for the homogeneity of the patients
-The statistical analysis will be carried out with the statistical test t-test

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

14/01/2019

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Navarra

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Mireia Aguado Jarauta

Address [1]

Mireia Aguado Osteopatia & Fisioterapia
Calle cofrete 8, bajo
Murchante 31521
Navarra
España

Country [1]

Spain

Primary sponsor type

Individual

Name

Mireia Aguado Jarauta

Address

Mireia Aguado Osteopatia & Fisioterapia
Calle cofrete 8, bajo
Murchante 31521
Navarra
España

Country

Spain

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

Escuela de Osteopatia de Madrid

Address [1]

Calle de San Félix de Alcalá, 4
28807 Alcalá de Henares
Madrid, España

Country [1]

Spain

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ETHIC OF CLINICAL RESEARCH OF NAVARRA

Ethics committee address [1]

Pabellón de docencia
Irunlarrea, 3
31008 Pamplona (Navarra)

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

03/09/2018

Approval date [1]

23/11/2018

Ethics approval number [1]

Summary

Brief summary

-The main objective of the study is to verify that the technique of stretching the uterine ligaments externally in women with primary dysmenorrhea improves the presence, intensity and quantity of symptoms related to the menstrual cycle according to the MDQ in the following two menstrual cycles after the handling.
-We can assume that the technique improves uterine blood flow we will reduce uterine ischemia, and with it improve the presence, intensity and quantity of symptoms related to the menstrual cycle according to the MDQ in the days after manipulation, in the next two menstrual cycles to manipulation.
-There are two study groups, an experimental group and a control group. In both the diagnosis and evaluation technique is the same, but they differ in the therapeutic technique. The diagnosis of primary dysmenorrhoea will be made according to the Primary dysmenhorrea consensus guideline. All patients will follow the treatment prescribed by their doctor if they have it. The evaluation will be by means of the Analog Visual Scale (VAS) and the Menstrual Distress Questionnaire (MDQ). The Visual Analog Scale (VAS) will be used to measure the maximum intensity of the pelvic pain that they have had in the last menstrual cycle. The evaluation will be made on the seventh day of the two menstrual cycles before the intervention, the seventh day of the woman's next menstrual cycle (cycle in which the treatment technique is performed) and the seventh day of the two menstrual cycles following the intervention. The Menstrual Distress Questionnaire (MDQ) will be used to measure the presence, intensity and quantity of symptoms associated with the menstrual cycle and will be performed on the seventh day of the five menstrual cycles that we will evaluate, that is, the two menstrual cycles prior to the menstrual cycle. intervention, the menstrual cycle of the intervention and the next two menstrual cycles after the intervention. The treatment technique of the experimental group is the technique of stretching the uterine ligaments externally and the therapeutic technique of the control group is to apply an ultrasound off during 5 minutes in the region of the uterus in the abdomen. A single treatment session is performed, the first day of the woman's menstrual cycle, and the effects in both groups are evaluated. Likewise, after completing the data collection Pre and Post treatment, the control group will be applied the treatment technique of the experimental group to avoid ethical issues for leaving them without treatment.
-If the technique shows a decrease in pain and other menstrual symptoms can help improve the quality of life of women who suffer from it in a simple and without sequels, will reinforce the theory of using treatment techniques that improve vascularization to combat The arterial vasoconstriction of the uterus in dysmenorrhoea will demonstrate the effectiveness of osteopathy in this pathology and will help to reduce drug costs or even work absenteeism

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Mireia Aguado Jarauta

Address

Calle cofrete 8, bajo
Murchante 31521
Navarra
España

Country

Spain

Phone

+34 622 74 53 33

Fax

osteopatiamaguado@gmail.com

Contact person for public queries

Name

Mireia Aguado Jarauta

Address

Calle cofrete 8, bajo
Murchante 31521
Navarra
España

Country

Spain

Phone

+34 622 74 53 33

Fax

osteopatiamaguado@gmail.com

Contact person for scientific queries

Name

Mireia Aguado Jarauta

Address

Calle cofrete 8, bajo
Murchante 31521
Navarra
España

Country

Spain

Phone

+34 622 74 53 33

Fax

osteopatiamaguado@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The data of the participants will be considered jointly in the statistical analysis, since it is not the objective of the study to analyze them individually

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
561	Ethical approval					374189-(Uploaded-29-11-2018-03-12-41)-Study-related document.pdf

Results publications and other study-related documents

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