Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.

Study Overview
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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.

Official Title
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A Randomised Clinical Trial of the Effects of Kinesiotaping vs.Auricular Therapy in Women With Primary Dysmenorrhoea.

Conditions
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Primary Dysmenorrhoea

Intervention / Treatment
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* Procedure: Auricular therapy
* Procedure: kinesio tape
* Procedure: Auricular therapy Placebo group
* Procedure: kinesio tape Placebo group


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular therapy group<br>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. | Procedure: Auricular therapy<br>* 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].<br>* Other names: auriculotherapy;|
| Sham Comparator: Auricular therapy Placebo group<br>The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points. | Procedure: Auricular therapy Placebo group<br>* Sham auricular therapy<br>|
| Experimental: Kinesio tape group<br>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. | Procedure: kinesio tape<br>* 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.<br>* Other names: neuromuscular taping;|
| Sham Comparator: kinesio tape Placebo group<br>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. | Procedure: kinesio tape Placebo group<br>* Sham kinesio tape<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from the Mean pain intensity | Mean pain intensity of the 3 first days of menstruation measured with the Visual Analogue Scale. Scores range from 0 to 10 where where 0 means no pain and 10 means maximum and excruciating pain. | Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up) | 
| Changes from the Maximum pain intensity | Maximum pain intensity during menstruation measured with the Visual Analogue Scale. Scores range from 0 to 10 where where 0 means no pain and 10 means maximum and excruciating pain. | Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up) | 
| Changes from number of painful days | Count of number of days when the participant experienced pain during the menstruation. A lower number of painful days indicate an improvement | Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up) | 
| Changes from the dosage of drug intake | Register of dosage and grug intake of each participant to relief pain during the menstruation. A lower dose of drug intake indicate an improvement. | Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from the Length of the menstrual cycle | Count of days that the menstrual cycle lasted for. | Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up) | 
| Changes from the Length of menstruation | Count of days that menstruation lasted for. | Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up) | 
| Changes from theType of drug | Record of type of medication used by the participants during the menstruation for pain relief. | Measured at the end of the menstruation of 4 cycles (28 days) during the pre-treatment and the treatment phase (total of 8 measurements) and at the end of the menstruation of the 9th and 11th cycle (Follow up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auricular therapy, kinesio tape