TENS for Primary Dysmenorrhea

NCT07521553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-04-13

No results posted yet for this study

Summary

Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of pelvic pathology. It affects a large proportion of women of reproductive age and may significantly interfere with daily activities, academic performance, and quality of life. Although pharmacological treatments such as nonsteroidal anti-inflammatory drugs are frequently used to manage menstrual pain, some women experience insufficient relief or prefer non-pharmacological treatment options.

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy technique widely used in pain management. TENS is thought to reduce pain through mechanisms including modulation of nociceptive transmission at the spinal cord level and activation of endogenous analgesic pathways. Portable TENS devices may provide a convenient and accessible option for self-management of menstrual pain.

The aim of this randomized controlled pilot study was to evaluate the effectiveness of a portable TENS device in reducing pain intensity in women with primary dysmenorrhea. Participants diagnosed with primary dysmenorrhea were randomly assigned to either an intervention group receiving treatment with a portable TENS device or a control group receiving usual care.

The intervention consisted of the application of a portable TENS patch to the lower abdominal region during menstrual pain episodes. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each treatment session lasted approximately 20 minutes and was applied during menstrual pain episodes.

Participants were followed for up to three menstrual cycles. Pain intensity was assessed using a visual analogue scale (VAS). Additional outcomes included quality of life assessed using the Short Form-12 Health Survey (SF-12), anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS), female sexual function evaluated with the Female Sexual Function questionnaire (FSM), and analgesic medication use recorded in a pain diary.

The results of this study aim to contribute to the evidence on non-pharmacological interventions for menstrual pain and to evaluate the potential role of portable TENS devices as a safe and accessible option for women with primary dysmenorrhea.

Conditions

  • Primary Dysmenorrhea
  • Menstrual Pain
  • Dysmenorrhea

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

Participants received treatment with a portable transcutaneous electrical nerve stimulation (TENS) device applied to the lower abdominal region during episodes of menstrual pain. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each session lasted approximately 20 minutes, with stimulation intensity adjusted individually to a strong but comfortable sensory level. The intervention was self-administered during menstrual pain episodes across up to three consecutive menstrual cycles.

Sponsors & Collaborators

  • Centro Universitario La Salle

    lead OTHER

Principal Investigators

  • Jose Vicente León Hernández, PhD · CSEU La Salle, UAM (Madrid)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-11-01
Completion
2019-12-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521553 on ClinicalTrials.gov