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

Primary Dysmenorrhea Clinical Trial

Official title:

The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178589
• Other study ID #: HS-21-00629
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: October 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 1, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• One Unit TENS
TENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Single unit TENS was administered via 2 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day.
• Two Unit TENS
TENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Double unit TENS was administered via 4 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day.

Locations

Country	Name	City	State
United States	University of Southern California Health Sciences Campus Center for Health Professions	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The surface area of TENS pain relief	Participants will use either one or 2 unit TENS.	1 month
Primary	Analgesic effects of TENS on primary dysmenorrhea.	To determine whether TENS will reduce pain symptoms in those with primary dysmenorrhea. Subjective pain will be assessed using an 11 point visual analog scale (VAS). The scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.	1 month
Secondary	Change in analgesic pill consumption during menstruation	Participants will be administered a daily survey where they will be asked to record analgesic pill intake throughout the day.	1 month