Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.

NCT04400968 | Completed

• 1 other identifier: 58/2017
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Dysmenorrhoea

Keywords

auricular therapy; kinesio tape

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Changes from the Length of the menstrual cycle

  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

  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

  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)

Study Arms (5)

Auricular therapy group

EXPERIMENTAL

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

Auricular therapy Placebo group

SHAM COMPARATOR

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

Procedure: Auricular therapy Placebo group

Kinesio tape group

EXPERIMENTAL

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

kinesio tape Placebo group

SHAM COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

Auricular therapy 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 \[PC2\].

Also known as: Auricular acupuncture, ear therapy, auriculotherapy

Auricular therapy group

kinesio tape 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.

Also known as: medical taping concept, neuromuscular taping

Kinesio tape group

Auricular therapy Placebo group PROCEDURE

Sham auricular therapy

Auricular therapy Placebo group

kinesio tape Placebo group PROCEDURE

Sham kinesio tape

kinesio tape Placebo group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Women with Primary dysmenorrhoea , a pathology that only affects women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

University of Extremadura

Badajoz, 06011, Spain

Location

MeSH Terms

Interventions

Acupuncture, Ear; Auriculotherapy; Athletic Tape

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 26, 2020
• Study Start: October 1, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)