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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous tibial nerve stimulation | Experimental | The participant will receive an intervention session per week that will be held for a period of 12 weeks. The total application time will be 30 minutes. A symmetrical biphasic current will be applied, with a frequency of 20 Hz in continuous mode and a pulsed frequency of 200 µs. |
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| Placebo | Placebo Comparator | The participant will receive one intervention session per week will be performed during a 12 weeks period time. The total application time will be 30 minutes. 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 in other localization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous tibial nerve stimulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain perception assessed using a 100 mm Visual Analogue Scale (VAS). | The scale will be self-administered. Minimum value 0. Maximum value 100. Higher score = Higher level of pain. Lower and lower scores mean a better result. | Once a month for 6 months. Thereafter, at 3 months and at 6 months. |
| Changes in pain perception assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ®). | The questionnaire will be self-administered. The total score ranges from 0 to 45. Higher score = Higher level of pain. Lower and lower scores mean a better result. | Once a month for 6 months. Thereafter, at 3 months and at 6 months. |
| Changes in the non-steroidal anti-inflammatory drugs (NSAID) intake using a NSAID diary designed for this study. | The questionnaire will be self-administered. | Once a month for 6 months. Thereafter, at 3 months and at 6 months. |
| Changes in life quality assessed using the SF36 Health Survey (SF-36v2®). | The questionnaire will be self-administered. Minimum value 0. Maximum value 100. The higher the score, the better the state of health. | Once a month for 6 months. Thereafter, at 3 months and at 6 months. |
| Changes in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI®). | The scale will be self-administered. The total score ranges from 0 to 21. The higher the score, the worse the sleep state. | Once a month for 6 months. Thereafter, at 3 months and at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the overall improvement and satisfaction of the treatment using the Patient Global Impression of Change (PGIC®) questionnaire. | The questionnaire will be self-administered. The total score ranges from 1 to 7. The higher the score, the worse the impression of change. | At 5 months and at 11 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Correyero-León, Doc student | University of Salamanca | Principal Investigator |
| Inés Llamas-Ramos, PhD | University of Salamanca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USalamanca | Salamanca | 37007 | Spain |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
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| Placebo | Procedure | 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. |
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| To assess the overall improvement and satisfaction of the treatment using a Likert Scale designed for this study. |
The questionnaire will be self-administered. The scale qualitatively expresses the degree of agreement or disagreement with the treatment. The higher the score, the better the satisfaction with the treatment. |
| At 5 months and at 11 months. |
| To collect the possible adverse reactions caused by the treatment. | It will be assessed using an adverse reactions questionnaire that was designed for the study. It will be self-administered. This questionnaire does not have minimum and maximum values, it is an open question. | Once a week for 12 weeks. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |