Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.
NCT ID: NCT04400968
Last Updated: 2020-05-26
Study Results
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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COMPLETED
NA
160 participants
INTERVENTIONAL
2017-10-01
2018-08-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
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 \[PC2\].
Auricular therapy Placebo group
The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points.
Auricular therapy Placebo group
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.
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.
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.
kinesio tape Placebo group
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.
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 \[PC2\].
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.
Auricular therapy Placebo group
Sham auricular therapy
kinesio tape Placebo group
Sham kinesio tape
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
30 Years
FEMALE
No
Sponsors
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University of Extremadura
OTHER
Responsible Party
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Elisa María Garrido Ardila
PHD
Locations
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University of Extremadura
Badajoz, , Spain
Countries
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Other Identifiers
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58/2017
Identifier Type: -
Identifier Source: org_study_id
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