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Trial registered on ANZCTR


Registration number
ACTRN12620000395932
Ethics application status
Approved
Date submitted
24/10/2019
Date registered
23/03/2020
Date last updated
23/03/2020
Date data sharing statement initially provided
23/03/2020
Date results information initially provided
23/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of the application of lymphatic neuromuscular taping technique in women with primary dysmenorrhea versus short-wave
Scientific title
Effects of the application of lymphatic neuromuscular technique in women with primary dysmenorrhea versus short-wave
Secondary ID [1] 299473 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dysmenorrhea 314844 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313181 313181 0 0
Physiotherapy
Renal and Urogenital 313956 313956 0 0
Pelvic inflammatory disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A clinical study, with double blind masking (evaluator and patient). The sample size was 40 women with a previous diagnosis of primary dysmenorrhea. It was randomly divided into two homogeneous groups, to the experimental group A (Bandage Group (GV)) a VNM lymphatic technique was applied to physioterapist in the hypogastric region that it maintained for three days.
The technique performed was the octopus technique bilaterally on the hypogastric region with the patient supine, placing the base on the upper edge of the pubic symphysis and directing the strips without tension obliquely towards the homolateral flank, keeping the patient lying down for 20 minutes after application . The patient was instructed to wear it for three consecutive days and inform if there was any problem with the bandage

The strategy used to monitor compliance with the intervention was carried out by interview

Data were taken on abdominal pain, low back pain, pressure pain threshold (UDP) in the right, left and spinous sacro-iliac of L5, before the intervention, after 20 minutes and 24 hours after the intervention.
They were given a menstrual pain questionnaire before the intervention and on the first day of the period of the following month.
 
Intervention code [1] 315827 0
Rehabilitation
Intervention code [2] 315828 0
Treatment: Other
Comparator / control treatment
The experimental group B (Electrotherapy group (GE)), Pulsed Short Wave was applied in the hypogastric region with emission for 20 minutes. (Curapuls_650 model. Manufacturer: Enraf Nonius, Rotterdam, Netherlands) with a maximum power of 200 W, peak power of 160 W / cm 2 and frequency 60 Hz.

Data were taken on abdominal pain, low back pain, pressure pain threshold (UDP) in the right, left and spinous sacro-iliac of L5, before the intervention, after 20 minutes and 24 hours after the intervention.
They were given a menstrual pain questionnaire before the intervention and on the first day of the period of the following month.
Control group
Active

Outcomes
Primary outcome [1] 321698 0
Pressure pain threshold
An algometer (Baseline Dolorimeter, Baseline, USA) was used to assess the pain threshold for pressure at the joint point chosen in the study (sacro-iliac and spiny L5).
Timepoint [1] 321698 0
Immediately after application, 20 minutes after the intervention, 24 hours after the intervention and the following month coinciding with the first day of menstruation
Primary outcome [2] 321699 0
Pain intensity.
To assess the intensity of pain in the lumbo-sacral spine and in the abdominal region, we use the Visual Analog Scale (VAS). To do this, patients are shown a horizontal line of 100 mm in length, with numbers from 0 to 10, which indicates to patients that 0 means lack of pain and 10 means unbearable pain.
Timepoint [2] 321699 0
Immediately after application, 20 minutes after the intervention, 24 hours after the intervention and the following month coinciding with the first day of menstruation
Secondary outcome [1] 375943 0
Menstrual Pain Questionnaire. It,s a composite secundary outcome.
The questionnaire includes information on the following points: socio-demographic data (age, profession, level of education); factors that can influence menstrual pain (number of children, years since the first menstruation); characterization of menstrual pain (intensity and location of pain, number of painful periods, time of onset of pain); request for professional help because of menstrual pain; symptoms associated with menstrual pain; strategies used to relieve pain (medication and rest); other symptoms and disorders
Timepoint [1] 375943 0
Immediately after application, 20 minutes after the intervention, 24 hours after the intervention and the following month coinciding with the first day of menstruation

Eligibility
Key inclusion criteria
To participate in this study, the following inclusion criteria were required: female patients, aged between 18-45 years, with a diagnosis of primary dysmenorrhea on the first day of menstruation who had not received manual treatment in the last month, to not interfere with the results, and sign an informed consent document
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The following subjects were excluded: patients who presented secondary dysmenorrhea, gynecological interventions, intrauterine device and contraindication to the use of Kinesiotaping and / or the shortwave.

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)
Participants who met the inclusion criteria were divided into 2 groups by random sampling using randomized number software (www.randomizer.org). Two groups were thus formed: GV and GE.
The subjects of the GV group were performed the kinesiotaping technique on the hypogastric region according to the lymphatic technique. To the subjects of the GE group, the OCP was applied for 20 minutes on the hypogastric region.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The PASW Statistics tool, version 18.0 (SPSS Inc., Chicago, IL) was used for the statistical analysis.
A descriptive analysis of all the variables included in the study is performed. This analysis includes both the variables of the menstrual pain questionnaire and the pre-intervention variables, visual analogue scale and pressure pain threshold.
It is verified by the Shapiro-Wilks test that the quantitative variables had no normal distribution, so non-parametric statistical tests were applied.
Qualitative variables are expressed by relative frequencies in each of the groups and by median and interquartile range in quantitative variables.
To assess that the random assignment of the intervention has not generated selection bias in the treatment groups, a bivariate analysis was performed between both treatment branches.
In this analysis, qualitative variables were assessed by Pearson's chi-square test or Fisher's exact test according to the application conditions and by Mann-Whitney U test for quantitative variables.
To assess the difference in the effect of the experimental intervention GV and GE post-treatment and 24 hours after the treatment against the baseline value was performed by the Wilcoxon W test, the evaluation of the values was obtained immediately after the intervention against the at baseline and at 24h post-treatment versus baseline, separately. To evaluate the three parameters (baseline, post intervention and at 24h) jointly, the non-parametric Friedman test was applied.
To evaluate the differences obtained between both treatment groups in all the outcome variables, the non-parametric Mann-Whitney U test was performed both after the intervention and at 24 h.
In all statistical tests a level of significance p <0.05 was considered.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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] 21928 0
Spain
State/province [1] 21928 0
Madrid

Funding & Sponsors
Funding source category [1] 303973 0
Self funded/Unfunded
Name [1] 303973 0
Elena Sánchez Jiménez
Address [1] 303973 0
Instituto Fyos Salud.
C/Mariblanca 7 1º 7
28937 Móstoles(Madrid)
Country [1] 303973 0
Spain
Primary sponsor type
Individual
Name
Elena Sanchez Jimenez
Address
Instituto Fyos Salud
C/Mariblanca 7 1º 7
28937 Móstoles(Madrid)
Country
Spain
Secondary sponsor category [1] 305385 0
None
Name [1] 305385 0
Address [1] 305385 0
Country [1] 305385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304473 0
Comité Ético de la Universidad Católica de Ávila
Ethics committee address [1] 304473 0
Calle de los Canteros, S/N,
C.P. 05005 Ávila
Ethics committee country [1] 304473 0
Spain
Date submitted for ethics approval [1] 304473 0
Approval date [1] 304473 0
08/10/2014
Ethics approval number [1] 304473 0

Summary
Brief summary
The high incidence of menstrual pain in the female population and its impact on the level of quality of life of said population, as well as the socio-economic impact, justifies the search for complementary therapies.
It was a randomized clinical trial.
The objective of this study is to assess the immediate and short-term effectiveness of the physiotherapeutic intervention through the application of a kinesiotaping lymphatic technique on the hypogastric and pulsatile shortwave region on the first day of the period in women diagnosed with primary dysmenorrhea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97070 0
Dr Elena Sánchez Jiménez
Address 97070 0
Instituto Fyos Salud
C/Mariblanca 7 1º7
28937 Móstoles
Madrid
Country 97070 0
Spain
Phone 97070 0
+34650331973
Fax 97070 0
Email 97070 0
elena.sanchez@ucavila.es
Contact person for public queries
Name 97071 0
Dr Elena Sánchez Jiménez
Address 97071 0
Instituto Fyos Salud
C/Mariblanca 7 1º7
28937 Móstoles
Madrid
Country 97071 0
Spain
Phone 97071 0
+34650331973
Fax 97071 0
Email 97071 0
elena.sanchez@ucavila.es
Contact person for scientific queries
Name 97072 0
Dr Elena Sánchez Jiménez
Address 97072 0
Instituto Fyos Salud
C/Mariblanca 7 1º7
28937 Móstoles
Madrid
Country 97072 0
Spain
Phone 97072 0
+34650331973
Fax 97072 0
Email 97072 0
elena.sanchez@ucavila.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
there is no reason
What supporting documents are/will be available?
Informed consent form
Ethical approval
Other
'Other' documents specified
Information sheet.
How or where can supporting documents be obtained?
Type [1] 5362 0
Ethical approval
Citation [1] 5362 0
Link [1] 5362 0
Email [1] 5362 0
Other [1] 5362 0
Type [2] 5462 0
Informed consent form
Citation [2] 5462 0
Link [2] 5462 0
Email [2] 5462 0
Other [2] 5462 0
Type [3] 5463 0
Other
Citation [3] 5463 0
Link [3] 5463 0
Email [3] 5463 0
Other [3] 5463 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
In the experimental group there are statistically significant differences in the abdominal pain in the post-intervention and 24 hours missing these effects shown in the following menstruation and in the lumbo-sacral pain, in the right sacroiliac pain, left and fifth lumbar vertebra pain after the intervention at 20 minutes.

It is observed that with the exception of swollen chest and gastric disorders all symptoms increase the duration in the month following the intervention in the control group. In the experimental group, the duration of symptoms does not vary, with the exception of gastric disorders and swollen chest but without statistically significant intragroup differences .

There are no intergroup differences in any of the variables studied at each moment of measurement except for the frequency in gastric disorders at the beginning, the experimental group having fewer days of symptomatology and significance in the irritability variable when comparing the two groups the month following the intervention improving the experimental group.

Our study has limitations; We have not evaluated the effects obtained after a longer period of time, as well as the short, medium or long-term follow-up, so these actions could be carried out in future investigations. We have only evaluated the effects of a single technique, and not the effect of a comprehensive treatment.