Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.

NCT ID: NCT04400968

Last Updated: 2020-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-08-30

Brief Summary

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This study analyse the effectiveness of auricular therapy vs. kinesio tape treatment for pain management of women with primary dysmenorrhoea.

Detailed Description

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Pharmacological treatments are not effective for all women and therefore, the objective of this study was to assess and compare the effectiveness of kinesio tape and auricular therapy to decrease pain and drug intake in women with primary dysmenorrhoea.

A randomized controlled trial was conducted. 114 university women from 18 to 30 years old were randomized to 5 groups: control, kinesio tape, placebo kinesio tape, auricular therapy and placebo auricular therapy. The study was carried out during 4 menstrual cycles of pre-treatment phase, 4 menstrual cycles of treatment phase and two follow up phases (first and third cycle after the treatments were completed). During the treatment phase, the techniques were applied during 72h in each cycle.

The primary outcome measures were: Mean pain intensity of the 3 first days of bleeding, maximum pain intensity, number of painful days and dose of drug intake measured with the Visual Analogue Scale.

Conditions

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Primary Dysmenorrhoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind randomized clinical controlled trial. Participants were randomized to a auricular therapy group, an auricular therapy placebo group, a kinesio tape group, a kinesio tape placebo group and a control group for a 11 month study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participants in the different intervention groups received real and placebo auricular therapy and kinesio tape treatment.

The kinesio tape placebo group had the application of three elastic bandages that were shorter than the used in the kinesio tape group. In addition, the tape was adhered with no tension and not place in the treatment area. The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points.

The outcome assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.

Study Groups

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Auricular therapy group

The auricular therapy group received an intervention based on the bilateral application of 7 adhesive tapes with vaccaria seeds. The points were located with a retractable 250 gr. pressure palpator (Sedatelec®). An experienced health professional trained on acupuncture techniques applied the vaccaria seeds.

Group Type EXPERIMENTAL

Auricular therapy

Intervention Type PROCEDURE

The auricular therapy points were selected following the protocol for dysmenorrhoea described by Oleson (Oleson, 2008). These points were (the name of the European cartography is specified by the name of the point): Shenmen \[FT2\], uterus \[FT5\], sympathetic \[HI4\], kidney \[CS6\], heart \[CI4\], endocrine \[IT2\] and thalamus \[PC2\].

Auricular therapy Placebo group

The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points.

Group Type SHAM_COMPARATOR

Auricular therapy Placebo group

Intervention Type PROCEDURE

Sham auricular therapy

Kinesio tape group

The kinesio tape group received an intervention that consisted on the standard application of three elastic bandages. An experienced kinesio tape certified physical therapist applied the taping.

Group Type EXPERIMENTAL

kinesio tape

Intervention Type PROCEDURE

Before the tape application, the skin surface was removed of hair when needed and cleansed. The tapes were applied at 25% of tension and were placed horizontally covering the area between the antero-superior iliac spines and the postero-superior iliac spines and vertically from the navel to the symphysis pubis. All bandages were adhered to the skin with a technique type I with a space augmentation. The centre of the tape was removed and applied at 25% of tension. Afterwards, the rest of the protector were removed and the laterals anchors of the tape were adhered with no tension. The participant maintained a slight extension of the trunk while the tape was applied on the anterior aspect of the truck and a slight flexion while the tape was applied in the posterior aspect of the trunk.

kinesio tape Placebo group

The kinesio tape placebo group had the application of three elastic bandages that were shorter than the used in the kinesio tape group. In addition, the tape was adhered with no tension and not place in the treatment area.

Group Type SHAM_COMPARATOR

kinesio tape Placebo group

Intervention Type PROCEDURE

Sham kinesio tape

Control group

The control group did not receive any treatment. The participants continued with their routine medical treatment. However, the controls completed all the questionnaires to collect the information regarding their symptoms in order to observe their progress with no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Auricular therapy

The auricular therapy points were selected following the protocol for dysmenorrhoea described by Oleson (Oleson, 2008). These points were (the name of the European cartography is specified by the name of the point): Shenmen \[FT2\], uterus \[FT5\], sympathetic \[HI4\], kidney \[CS6\], heart \[CI4\], endocrine \[IT2\] and thalamus \[PC2\].

Intervention Type PROCEDURE

kinesio tape

Before the tape application, the skin surface was removed of hair when needed and cleansed. The tapes were applied at 25% of tension and were placed horizontally covering the area between the antero-superior iliac spines and the postero-superior iliac spines and vertically from the navel to the symphysis pubis. All bandages were adhered to the skin with a technique type I with a space augmentation. The centre of the tape was removed and applied at 25% of tension. Afterwards, the rest of the protector were removed and the laterals anchors of the tape were adhered with no tension. The participant maintained a slight extension of the trunk while the tape was applied on the anterior aspect of the truck and a slight flexion while the tape was applied in the posterior aspect of the trunk.

Intervention Type PROCEDURE

Auricular therapy Placebo group

Sham auricular therapy

Intervention Type PROCEDURE

kinesio tape Placebo group

Sham kinesio tape

Intervention Type PROCEDURE

Other Intervention Names

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Auricular acupuncture ear therapy auriculotherapy medical taping concept neuromuscular taping

Eligibility Criteria

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Inclusion Criteria

* Women between 18 and 30 years old affected by primary dysmenorrhoea grade 2 and 3 of Andersch y Milsom classification (Andersch y Milsom, 1982), to have attended gynaecologist consultation for a general revision in the last 2 years, to have menstrual pain, to have regular menstrual cycles of 21 to 38 days, to not have an intrauterine/inter-uterine) device or to be on oral contraceptive treatment.

Exclusion Criteria

* To have been diagnosed with a condition that could influence menstrual pain perception, to know or have been previously treated with the techniques used in the interventions and pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Extremadura

OTHER

Sponsor Role lead

Responsible Party

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Elisa María Garrido Ardila

PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Extremadura

Badajoz, , Spain

Site Status

Countries

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Spain

Other Identifiers

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58/2017

Identifier Type: -

Identifier Source: org_study_id

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