search
Back to results

Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.

Primary Purpose

Primary Dysmenorrhoea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Auricular therapy
kinesio tape
Auricular therapy Placebo group
kinesio tape Placebo group
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhoea focused on measuring auricular therapy, kinesio tape

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Extremadura

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

No Intervention

Arm Label

Auricular therapy group

Auricular therapy Placebo group

Kinesio tape group

kinesio tape Placebo group

Control group

Arm Description

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.

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

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.

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 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.

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Changes from the Length of the menstrual cycle
Count of days that the menstrual cycle lasted for.
Changes from the Length of menstruation
Count of days that menstruation lasted for.
Changes from theType of drug
Record of type of medication used by the participants during the menstruation for pain relief.

Full Information

First Posted
May 9, 2020
Last Updated
May 19, 2020
Sponsor
University of Extremadura
search

1. Study Identification

Unique Protocol Identification Number
NCT04400968
Brief Title
Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.
Official Title
A Randomised Clinical Trial of the Effects of Kinesiotaping vs.Auricular Therapy in Women With Primary Dysmenorrhoea.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhoea
Keywords
auricular therapy, kinesio tape

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auricular therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Auricular therapy Placebo group
Arm Type
Sham Comparator
Arm Description
The auricular therapy placebo group had adhesive tapes without seeds displaced from the treatment points.
Arm Title
Kinesio tape group
Arm Type
Experimental
Arm Description
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.
Arm Title
kinesio tape Placebo group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Auricular therapy
Other Intervention Name(s)
Auricular acupuncture, ear therapy, auriculotherapy
Intervention Description
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
Intervention Name(s)
kinesio tape
Other Intervention Name(s)
medical taping concept, neuromuscular taping
Intervention Description
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
Intervention Name(s)
Auricular therapy Placebo group
Intervention Description
Sham auricular therapy
Intervention Type
Procedure
Intervention Name(s)
kinesio tape Placebo group
Intervention Description
Sham kinesio tape
Primary Outcome Measure Information:
Title
Changes from the Mean pain intensity
Description
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.
Time Frame
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)
Title
Changes from the Maximum pain intensity
Description
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.
Time Frame
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)
Title
Changes from number of painful days
Description
Count of number of days when the participant experienced pain during the menstruation. A lower number of painful days indicate an improvement
Time Frame
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)
Title
Changes from the dosage of drug intake
Description
Register of dosage and grug intake of each participant to relief pain during the menstruation. A lower dose of drug intake indicate an improvement.
Time Frame
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 Measure Information:
Title
Changes from the Length of the menstrual cycle
Description
Count of days that the menstrual cycle lasted for.
Time Frame
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)
Title
Changes from the Length of menstruation
Description
Count of days that menstruation lasted for.
Time Frame
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)
Title
Changes from theType of drug
Description
Record of type of medication used by the participants during the menstruation for pain relief.
Time Frame
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)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with Primary dysmenorrhoea , a pathology that only affects women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Extremadura
City
Badajoz
ZIP/Postal Code
06011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.

We'll reach out to this number within 24 hrs