Trial Review

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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] 293634 0
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 305907 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305097 305097 0 0
Physiotherapy
Reproductive Health and Childbirth 305098 305098 0 0
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] 299895 0
Treatment: Other
Intervention code [2] 299896 0
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] 304272 0
Change in the presence, intensity and quantity of symptoms related to the menstrual cycle according to the MDQ (Menstrual Distress Questionnaire).
Timepoint [1] 304272 0
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] 341457 0
Change in the perception of pain through the Visual Analogue Scale (EVA).
Timepoint [1] 341457 0
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?
No
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
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 9446 0
Spain
State/province [1] 9446 0
Navarra

Funding & Sponsors
Funding source category [1] 298251 0
Self funded/Unfunded
Name [1] 298251 0
Mireia Aguado Jarauta
Country [1] 298251 0
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] 297366 0
Other Collaborative groups
Name [1] 297366 0
Escuela de Osteopatia de Madrid
Address [1] 297366 0
Calle de San Félix de Alcalá, 4
28807 Alcalá de Henares
Madrid, España
Country [1] 297366 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299257 0
ETHIC OF CLINICAL RESEARCH OF NAVARRA
Ethics committee address [1] 299257 0
Pabellón de docencia
Irunlarrea, 3
31008 Pamplona (Navarra)
Ethics committee country [1] 299257 0
Spain
Date submitted for ethics approval [1] 299257 0
03/09/2018
Approval date [1] 299257 0
23/11/2018
Ethics approval number [1] 299257 0

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 79814 0
Ms Mireia Aguado Jarauta
Address 79814 0
Calle cofrete 8, bajo
Murchante 31521
Navarra
España
Country 79814 0
Spain
Phone 79814 0
+34 622 74 53 33
Fax 79814 0
Email 79814 0
[email protected]
Contact person for public queries
Name 79815 0
Ms Mireia Aguado Jarauta
Address 79815 0
Calle cofrete 8, bajo
Murchante 31521
Navarra
España
Country 79815 0
Spain
Phone 79815 0
+34 622 74 53 33
Fax 79815 0
Email 79815 0
[email protected]
Contact person for scientific queries
Name 79816 0
Ms Mireia Aguado Jarauta
Address 79816 0
Calle cofrete 8, bajo
Murchante 31521
Navarra
España
Country 79816 0
Spain
Phone 79816 0
+34 622 74 53 33
Fax 79816 0
Email 79816 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
561Ethical approval    374189-(Uploaded-29-11-2018-03-12-41)-Study-related document.pdf



Results publications and other study-related documents

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