Transcutaneous Electrical Nerve Stimulation for Pain

(TENS Trial)

Overseen By Michelle Meglin, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Opioids, Benzodiazepines, Marijuana, others

Disqualifiers: Chronic pain, Heart disease, others

Compensation: Varies

Number of Visits: 1

Duration: Single session

86 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigators are conducting a study to determine whether high frequency transcutaneous electrical nerve stimulation (hfTENS) is effective at reducing pain in women having an IUD inserted.

Eligibility Criteria

This trial is for English-speaking women aged 18 or older who are getting an IUD inserted at MUSC Women's Health and choose a specific type of IUD. They must be willing to follow the study rules and not have used TENS before, no severe obesity, heart issues, epilepsy, chronic pain disorders, recent opioid use, or electrical medical devices like pacemakers.

Inclusion Criteria

Stated willingness to comply with all study procedures

I am 18 or older and speak English.

Provision of signed and dated informed consent form for IUD Insertion

Exclusion Criteria

I have used a TENS unit before.

I have a history of irregular heartbeats.

My BMI is over 50, indicating class IV obesity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either active or placebo TENS during IUD placement

Single session

1 visit (in-person)

Follow-up

Participants are monitored for pain scores immediately after IUD insertion

5 minutes

Treatment Details

Interventions

• Transcutaneous Electrical Nerve Stimulation

Trial Overview The study is testing if high frequency transcutaneous electrical nerve stimulation (hfTENS) can lessen the pain when women have an IUD placed. It aims to see if this method is effective compared to standard care during the procedure.

Participant Groups

Group I: Active TENS Active Control 1 Intervention

A TENS 7000 digital TENS unit will be used. A research staff member will apply TENS pads to specified areas on the lower abdomen and lower back corresponding to T10-11 and S2-4 dermatomes. For the active treatment group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.

Group II: Placebo TENS Placebo Group 1 Intervention

A TENS 7000 digital TENS unit will be used. A research staff member will apply TENS pads to specified areas on the lower abdomen and lower back corresponding to T10-11 and S2-4 dermatomes. The TENS device will not be turned on.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+