Transcutaneous Tibial Nerve Stimulation as Treatment for Women With Primary Dysmenorrhea

Summary

The goal of this study is to verify whether transcutaneous stimulation of the posterior tibial nerve improves pain, quality of life and sleep deficiency in patients with pain related to their menstrual period in the short and medium-long term.

The hypothesis of the study states that by applying that method to the patients, a decrease or disappearance of pain in menstruation should happen, as well as an improvement in quality of life and sleep deficiency.

The study will consist of:

* An interview, lasting 30 minutes, in which the characteristics of the study will be explained. In case of wishing to participate, it will be required to sign the informed consent document and to fill out the medical history sheet.
* An evaluation phase: in which it will be necessary to fill out a number of questionnaires during two consecutive menstrual periods.
* An intervention phase: consisting of 12 30-minute treatment sessions, once a week. The patients will be randomly assigned to one of the two groups. In both groups, a current will be applied to different locations on the legs. The technique will be performed through four/two electrodes leg attached to the skin. This stimulation will not be painful at any time nor will it have harmful effects on the patients health. In this phase, the individual should continue filling out the questionnaires provided in each period. On the last day of treatment, a scale of satisfaction with the treatment will be retrieved.
* A re-evaluation phase: in which the individual shall fill out a number of questionnaires a month, 3 and 6 months after finishing the treatment.

Conditions

• Dysmenorrhea Primary

Interventions

PROCEDURE

Transcutaneous tibial nerve stimulation

The participant will be placed in the supine position with the soles of the feet together and the knees flexed and abducted at 90º. Two adhesive electrodes will be used for each leg. First one: 32 mm of diameter that will be placed in the posterior tibial nerve, that is, 4-5 cm cranial to the internal malleolus, between the posterior edge of the medial border of the tibia and the soleus tendon. Second one: 50x50 mm to be placed in the ipsilateral calcaneus. The electrodes will be connected to the NeuroTracTM PelviTone stimulation device. The stimulation range will be selected according to the tolerable pain limit for the patient, between 0.5 and 20 mA (adjustable in 1 mA levels).The intensity elevation will be allowed each time the patient perceives the fading of the previous sensation due to accommodation. Under no circumstances should the stimulation cause a painful feeling.

PROCEDURE

Placebo

The participant will be placed in the same position. Two 50 x 50 mm adhesive electrodes will be placed on the external face of the thigh, on a single leg. This area is outside the territory of the posterior tibial nerve. A discontinuous current at 2Hz frequency and a pulsed frequency of 50 µs, with 2 seconds of work and 10 seconds of pause will be applied. This simulated current being considered to be insufficient to achieve therapeutic effects in the body and to be outside of the usual ranges described in electrotherapy manuals regarding pain management. The intensity will be selected according to the paint limit level of the patient, between 0.5 and 60 mA (adjustable in 0.1 mA levels), where a low or moderate sensation of the patient will be sought, without muscle contraction.

Sponsors & Collaborators

• University of Salamanca

  lead OTHER

Principal Investigators

• Marta Correyero-León, Doc student · University of Salamanca

• Inés Llamas-Ramos, PhD · University of Salamanca

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

43 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-25

Primary Completion

2021-10-31

Completion

2022-04-30

Countries

• Spain

Study Locations