TENS for Primary Dysmenorrhea

NCT07521553 | Completed

• 1 other identifier: CSEULS-PI-025/2019
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary Dysmenorrhea; Menstrual Pain; Transcutaneous Electrical Nerve Stimulation; Non-Pharmacological Treatment; Pain Management; Women's Health

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured using the Visual Analogue Scale (VAS)

  Pain intensity associated with primary dysmenorrhea measured using a 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable.

  Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles

Secondary Outcomes (4)

• Health-related quality of life measured using the Short Form-12 Health Survey (SF-12)

  Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles

• Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)

  Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles

• Female sexual function assessed using the Female Sexual Function questionnaire (FSM)

  Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles

• Analgesic medication use recorded during menstrual pain episodes

  Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles

Study Arms (2)

TENS Intervention Group

EXPERIMENTAL

Portable transcutaneous electrical nerve stimulation (TENS) device applied to the lower abdominal region during menstrual pain episodes. The device delivered alternating cycles of high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each session lasted approximately 20 minutes, with intensity adjusted to a strong but comfortable sensory level.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Usual care control group

NO INTERVENTION

Participants continued their usual care during menstrual pain episodes, including the use of analgesic medication if needed.

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

TENS Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with primary dysmenorrhea
• History of recurrent menstrual pain without identifiable pelvic pathology
• Regular menstrual cycles
• Age between 18 and 45 years old
• Pain intensity of at least 4 on a 10-cm Visual Analogue Scale (VAS)
• Willingness to participate in the study and to comply with study procedures
• Provision of written informed consent

You may not qualify if:

• Secondary dysmenorrhea associated with identifiable pelvic pathology
• Pregnancy
• Irregular menstrual cycles
• Use of hormonal contraceptives initiated or modified during the study period
• Presence of gynecological or systemic conditions that could influence menstrual pain
• Contraindications to transcutaneous electrical nerve stimulation (TENS), such as pacemaker implantation or skin lesions at the electrode placement site
• Inability to understand study procedures or complete study questionnaires

Sponsors & Collaborators

• Centro Universitario La Salle: lead

Study Sites (1)

Universidad de Valencia

Madrid, Spain

Location

MeSH Terms

Conditions

Dysmenorrhea; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Jose Vicente León Hernández, PhD

  CSEU La Salle, UAM (Madrid)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label trial. No participants, care providers, investigators, or outcome assessors were blinded to group allocation due to the nature of the intervention (TENS vs usual care).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiotherapy, Centro Superior de Estudios Universitarios La Salle (UAM)

Model Details: Participants were randomly assigned in a 1:1 ratio to either an intervention group receiving transcutaneous electrical nerve stimulation (TENS) or a control group receiving usual care. The study used a parallel assignment design, with no crossover between groups. Participants remained in their allocated group throughout the study period. Outcomes were measured longitudinally at the end of each menstrual cycle (approximately 28 days per cycle), for up to three consecutive cycles.

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: April 13, 2026
• Study Start: June 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 20, 2019
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)