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Electric current applied to women with painful menstrual cramps: A randomized clinical trial with economic evaluation.

Transcutaneous electrical nerve stimulation for primary dysmenorrhea: A randomized clinical trial with economic evaluation. - TENS -Transcutaneous electrical nerve stimulation. PD - Primary Dysmenorrhea.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5bxtgx
Enrollment
Unknown
Registered
2019-11-01
Start date
2021-01-15
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

Dysmenorrhea

Interventions

active TENS group the current will be applied at a frequency of 100Hz with pulse duration of 200us for 30 minutes, maximal comfortable amplitude, with no muscle activation (sensory threshold). place
Device
HP3.073.433.101
E02.331.800
SH1.050.040.010

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
São Paulo Research Foundation
Collaborator
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Nulligravid women over 18 years old; women with a regular menstrual cycle; and women with PD: with a report of pain equal to or greater than four points on the Numerical Rating Scale in the last three months.

Exclusion criteria

Exclusion criteria: Pregnant women or postpartum women; women with intrauterine device (IUD); women with lesions in the area where the electrodes will be placed; women with neurological or cardiac diseases; and women with diagnose gynecological disorders such as endometriosis, adenomyosis and uterine fibroids

Design outcomes

Primary

MeasureTime frame
The primary outcome is pain intensity three- and six-months after randomization (11-point numerical rating scale)—

Secondary

MeasureTime frame
Pain intensity 12 months after randomization (11-point Numerical Rating Scale), pain intensity at each session before and after treatment during three months for TENS groups (11-point Numerical Rating Scale). ;Health-related quality of life six and 12 months after randomization (SF6D) and health costs about dysmenorrehea—

Countries

Brazil

Contacts

Public ContactJéssica ;Jéssica Rodrigues;Rodrigues

Universidade Federal de São Carlos;Universidade Federal de São Carlos

jessica.crodrigues13@gmail.com;jessica.crodrigues13@gmail.com+55-016-33519577;+55 33519577

Outcome results

None listed

Source: REBEC (via WHO ICTRP)