Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement

ConditionPain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorMedical University of South Carolina

About 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 does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form for IUD Insertion

Stated willingness to comply with all study procedures

English speaking individuals aged 18 years or older

Presenting for IUD initiation during ambulatory care visit at MUSC Women's Health

Disqualifiers

Contraindication to IUD initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy)

Contraindication or allergy to ibuprofen

History of a chronic pain disorder

Recent opioid use in the previous 30 days

Trial design

Design model

Parallel

Treatments tested in this trial

High frequency transcutaneous electrical nerve stimulation
Device
TENS 7000 digital TENS unit will be used.

Treatment groups

86 Participants

are divided into 2 treatment groups

Group A: Active TENSActive comparator 1 intervention

Group B: Placebo TENSPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Pain scores reported at IUD insertion

Pain scores at time of IUD insertion as measured by VAS scores between TENS and placebo groups

Time frame

From enrollment until 5 minutes after procedure completion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Icahn School of Medicine at Mount Sinai

Collaborator

Source ClinicalTrials.gov

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