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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high frequency transcutaneous electrical nerve stimulation (hfTENS) device can reduce pain for women receiving an IUD (a type of birth control). Participants will receive either the active hfTENS treatment or a placebo, where the device remains off. Women planning to get an IUD at MUSC Women's Health, without certain health conditions like heart problems or a history of chronic pain, might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance pain management during IUD insertion.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used opioids in the last 30 days or plan to use certain pain medications like benzodiazepines or marijuana before the procedure.

What prior data suggests that transcutaneous electrical nerve stimulation is safe for pain management during IUD insertion?

Research has shown that transcutaneous electrical nerve stimulation (TENS) is generally safe. Studies have found that TENS can reduce pain without causing serious side effects. For instance, one study discovered that people using TENS felt less pain compared to those using a placebo device, with no serious health issues linked to TENS. This treatment uses gentle electrical currents to relieve pain and is often used for conditions like arthritis and fibromyalgia. Overall, TENS is well-tolerated and usually does not cause major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Electrical Nerve Stimulation (TENS) is unique because it offers a non-drug approach to pain management, setting it apart from conventional treatments like opioids or NSAIDs. Unlike these medications, which can have significant side effects and risk of addiction, TENS uses electrical impulses to modulate pain signals, potentially reducing discomfort without systemic effects. Researchers are excited about TENS because it allows for customizable, patient-specific adjustments in intensity, providing personalized pain relief that aligns with individual comfort levels.

What evidence suggests that transcutaneous electrical nerve stimulation is effective for reducing pain during IUD insertion?

This trial will compare the effects of active transcutaneous electrical nerve stimulation (TENS) with a placebo TENS. Studies have shown that TENS can reduce pain during or immediately after use compared to a placebo. TENS sends small electrical pulses through the skin, which can lessen the body's pain response. Research has found TENS effective for various types of pain, both short-term and long-term. Although results can vary, moderate evidence suggests it can provide pain relief without serious side effects. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

History of epilepsy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9611192/

Using TENS for Pain Control: Update on the State of the ... This literature review supports the conclusion that TENS may have efficacy for a variety of acute and chronic pain conditions, although the magnitude of the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35144946/

Efficacy and safety of transcutaneous electrical nerve ... There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023003784

Review Article Effect of Transcutaneous Electrical Nerve ... Moderate evidence suggests that TENS promotes analgesia by reducing both central and peripheral sensitization.

4. mdpi.com mdpi.com/2077-0383/13/2/427

The Impact of Transcutaneous Electrical Nerve Stimulation ... This study aimed to investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) in postoperative acute pain control.

5. nejm.org nejm.org/doi/full/10.1056/NEJM199006073222303

A Controlled Trial of Transcutaneous Electrical Nerve ... Overall improvement in pain indicators was 47 percent with TENS and 42 percent with sham TENS (P not significant). The 95 percent confidence ...

6. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/15840-transcutaneous-electrical-nerve-stimulation-tens

Transcutaneous Electrical Nerve Stimulation (TENS) A TENS unit uses a mild electrical current to reduce pain. Providers use this therapy to treat conditions like osteoarthritis, tendinitis and fibromyalgia.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324012267

Usefulness and Safety of a Wearable Transcutaneous ... The group using TENS showed improved effects of early reduction in knee pain and when combined with exercise therapy, a reduction in time spent in light- ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537188/

Transcutaneous Electrical Nerve Stimulation - StatPearls - NCBI Transcutaneous electrical nerve stimulation (TENS) is a therapeutic modality employing electric current to relieve pain by activating peripheral nerves.

9. bmjopen.bmj.com bmjopen.bmj.com/content/12/2/e051073

Efficacy and safety of transcutaneous electrical nerve ... There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.