Transcutaneous Electrical Nerve Stimulation for Pain

Not currently recruiting at 1 trial location

Overseen By AmberJean Hansen, MPH, CCRP

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Opioids, Non-standard pain medication

Disqualifiers: Pelvic infection, Pregnancy, Heart disease, others

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Transcutaneous Electrical Nerve Stimulation (TENS) can reduce pain during the insertion of an IUD, a small device placed in the uterus to prevent pregnancy. TENS is a low-cost, non-drug method that has lowered pain in similar medical procedures. Participants will be divided into two groups: one will receive active TENS treatment, and the other will receive a placebo treatment. The trial seeks individuals planning to get an IUD at the Yale Family Planning service who do not have certain medical conditions, such as chronic pain disorders or heart issues.

As an unphased trial, this study offers a unique opportunity to contribute to 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 have used opioids recently or plan to use non-standard pain medications before the procedure.

What prior data suggests that this TENS device is safe for pain management during IUD insertion?

Research has shown that TENS (Transcutaneous Electrical Nerve Stimulation) is generally safe for pain relief. Studies have found it can reduce pain levels without causing serious side effects. For instance, one study noted that pain decreased during or immediately after using TENS, and no serious negative effects were reported. This suggests that patients tolerate TENS well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Electrical Nerve Stimulation (TENS) for pain management because it offers a non-invasive, drug-free alternative to standard pain treatments like medication or surgery. Unlike medications, TENS uses electrical impulses to stimulate nerves and reduce pain perception, potentially minimizing side effects associated with long-term drug use. Additionally, TENS devices allow for personalized intensity settings, making them adaptable to individual comfort levels, which is not possible with conventional treatments.

What evidence suggests that TENS is effective for pain control during IUD insertion?

Studies have shown that Transcutaneous Electrical Nerve Stimulation (TENS) effectively reduces pain in various situations. In this trial, participants will join either an Active TENS group or a Placebo TENS group. Research indicates that TENS lowers pain intensity during or immediately after use compared to a placebo, without causing serious side effects. Moderate evidence suggests that TENS helps by reducing nerve sensitivity to pain. Additionally, TENS has proven useful for pain control in some outpatient gynecological procedures. While not all studies find TENS significantly better than a placebo, its potential for pain relief is well-supported. ^{1 4 5 6 7}

Who Is on the Research Team?

Tessa Madden, MD, MPH

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals experiencing pain, specifically related to peripheral neuropathy, who are undergoing IUD insertion. Participants should be willing to use a TENS device and record their pain levels. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Patient Participants must provide a signed and dated informed consent form

Patient Participants must be presenting for IUD initiation or replacement during ambulatory care visits to the Yale Family Planning service and Center for Women's Health and Midwifery clinic

Provider Participants must review the provider participant study Information Sheet and provide verbal consent

Exclusion Criteria

Pregnant Patient Participants

Patient Participants with any other contraindications to IUD insertion as determined by the patient's clinical care staff

Patient Participants with current IUD and no visible strings

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either active or placebo TENS during IUD insertion

1 day

1 visit (in-person)

Follow-up

Participants complete post-procedure surveys to assess pain and device acceptability

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Nerve Stimulation (TENS)

Trial Overview The study tests high frequency TENS as a non-drug method for managing pain during IUD insertion. It's a double-blind study, meaning neither the participants nor the researchers know who gets real TENS or placebo. Pain relief effectiveness is measured using a visual scale.

How Is the Trial Designed?

Group I: Active TENS Active Control 1 Intervention

For the Active TENS 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

For the placebo TENS group, setup will be identical, but the device will not be turned on.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Society of Family Planning

Collaborator

Trials

100

Recruited

17,200+

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. 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.

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

Usefulness and Safety of a Wearable Transcutaneous ... The effect of pain reduction over time may have led to the high retention rate. Previous studies have also reported the effectiveness of TENS and exercise ...