The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief

University of Southern California

Status: Completed

Conditions: Primary Dysmenorrhea

Treatments: Device: Two Unit TENS; Device: One Unit TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT05178589

HS-21-00629

Details and patient eligibility

About

The present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a control period without usage.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• History of lower abdominal pain (dysmenorrhea) for more than 6 consecutive menstrual cycles with a moderate or severe pain rating ≥5 out of 10 over course of last year
• BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths
• Not taking contraception or other types of medication that could influence reproductive status
• Regular menstruation
• Medically free from chronic diseases
• Free from known gynecological problems (ie. Endometriosis, Fibroids, Ovarian Cysts)
• History of analgesic pill intake during menstruation
• No pelvic pathology

Exclusion criteria

• Amenorrhea
• On a form of contraception
• Secondary dysmenorrhea and/or other gynecological problems that may cause pain
• No discomfort, pain, or other symptoms during menstruation
• History of surgery over lower abdomen area
• Allergy to ibuprofen
• Cardiac disability
• Pacemaker
• Arterial disease
• Uncontrolled hemorrhage
• Blood clots
• Pregnancy or trying to become pregnant
• Cancerous lesions
• Exposed metal implants
• History of seizures
• Sensory or mental impairment
• Unstable fractures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

Control

No Intervention group

Description:

During the control condition cycle (no TENS), participants will refrain from using or taking other analgesics, besides ibuprofen.

One Unit TENS

Experimental group

Description:

Participants will use one-unit TENS set-up where the TENS unit has 2 channels.

Treatment:

Device: One Unit TENS

Two Unit TENS

Experimental group

Description:

Participants will use a two-unit TENS set-up where the TENS unit has 4 channels.

Treatment:

Device: Two Unit TENS