Effects of Kinesiotaping vs.Auricular Therapy in Primary Dysmenorrhoea.

University of Extremadura

Status: Completed

Conditions: Primary Dysmenorrhoea

Treatments: Procedure: Auricular therapy; Procedure: kinesio tape Placebo group; Procedure: Auricular therapy Placebo group; Procedure: kinesio tape

Study type: Interventional

Funder types: Other

Identifiers

NCT04400968

58/2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 5 patient groups

Auricular therapy group

Experimental group

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.

Treatment:

Procedure: Auricular therapy

Auricular therapy Placebo group

Sham Comparator group

Description:

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

Treatment:

Procedure: Auricular therapy Placebo group

Kinesio tape group

Experimental group

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.

Treatment:

Procedure: kinesio tape

kinesio tape Placebo group

Sham Comparator group

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.

Treatment:

Procedure: kinesio tape Placebo group

Control group

No Intervention group

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.