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Immediate effect of an electrostimulation session for Menstrual Cramp pain

Immediate effect of an electrostimulation session on pain related to Primary Dysmenorrhea

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10vpc86k
Enrollment
Unknown
Registered
2023-10-13
Start date
2023-03-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary dysmenorrhea

Interventions

The participants will initially undergo a clinical screening to verify the eligibility criteria and collect demographic, anthropometric and menstrual cycle and history data. Then, eligible participant
HORN-HOFFMAN et al, 2015), tobacco (DITRE et al, 2017) or that are stimulants, such as coffee and energy drinks (BARATLOO et al. , 2016) in the 24 hours preceding the evaluation in order to avoid any
CAUMO et al, 2017). All evaluations will take place during menstruation, preferably until the third day of the beginning of the menstrual cycle. Women will be contacted via WhatsApp® and asked about t

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Universidade Federal de São Carlos
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women without children; aged between 18 and 45 years; with regular menstrual cycle; with primary dysmenorrhea assessed with 3 points or more for dysmenorrhea pain intensity by Numerical Pain Scale (END); and who had never had previous contact with Transcutaneous Electrical Nerve Stimulation (TENS).

Exclusion criteria

Exclusion criteria: Pregnant women; postpartum women up to 6 months after delivery; women using an intrauterine device; presence of skin lesions at the electrode application site; with self-reported neurological and/or heart diseases; diagnosis of gynecological disorders (such as endometriosis, uterine fibroids, etc.) that may be related to secondary dysmenorrhea.

Design outcomes

Primary

MeasureTime frame
Decrease in temporal summation, evaluated pre and post intervention with active transcutaneous electrical nerve stimulation (TENS), through a constant pressure of 2.5 kg applied, through a manual pressure algometer, in the forearm region, at 7, 5cm from the distal crease of the wrist and held for 30s. Four pain assessments will be collected at 0, 10, 20 and 30s. A difference of at least 2 points in pain intensity in pre- and post-intervention measurements of active TENS is expected to verify a decrease in temporal summation.;Improvement in conditioned pain modulation (MCD), evaluated pre and post intervention with active transcutaneous electrical nerve stimulation (TENS). The MCD will be evaluated as follows: first, using the manual pressure algometer, pressure will be applied on the participant's dominant forearm, 7.5 cm from the distal crease of the wrist, until the patient reports a pain of intensity 4. The value of the pressure recorded in the algometer will be recorded in kg (pre-stimulus). Soon afterwards, on the contralateral arm, a sphygmomanometer cuff will be inflated at 250 mmHg until the participant reports a pain of intensity greater than four and, simultaneously, pressure will be applied again in the same region of the first test until the patient reports a pain of intensity equal to 4. The pressure value registered in the algometer will be recorded in kg (intra-stimulus). Finally, 30s will be waited to apply a new pressure in the same previously tested region, until the patient reports a pain of intensity equal to 4. The pressure value registered in the algometer will be recorded in kg (post stimulus). An increase of 2kg in the pressure applied to the algometer is expected to verify an improvement in the MCD after the application of active TENS.

Secondary

MeasureTime frame
A decrease in pain intensity pre and post intervention is expected with active transcutaneous electrical nerve stimulation (TENS). Pain intensity will be assessed using the Numerical Pain Scale (END), a scale of 11 items ranging from 0 to 10, with 0 being no pain and 10 being the worst possible pain. A decrease of at least 3 points in the END is expected to verify a positive effect of active TENS on the pain intensity of menstrual cramps.

Countries

Brazil

Contacts

Public ContactMaria da Silva

Universidade Federal de São Carlos

msilva@estudante.ufscar.br+55-16-3351-8111

Outcome results

None listed

Source: REBEC (via WHO ICTRP)