TENS Unit for Pain Relief During IUD Insertion

Overseen By Caitie McCarthy, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Tufts Medical Center

Must not be taking: Opioids

Disqualifiers: Prior cervical procedure, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a TENS unit, a device that sends small electrical pulses to the skin, can reduce pain during IUD insertion. Participants may choose standard pain relief methods or add the TENS unit to see if it increases comfort. The trial seeks individuals with a uterus who want to get an IUD and have not had one before. This study aims to determine if the TENS unit can serve as an effective pain management tool during this procedure. As an unphased study, it offers participants the chance to contribute to innovative pain management research.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you use opioids chronically or before the procedure, you cannot participate in the trial.

What prior data suggests that the TENS unit is safe for pain relief during IUD insertion?

Research shows that a TENS unit, a device that sends small electrical pulses to the body, is generally safe. Studies have found that TENS can reduce pain during procedures like IUD insertions, with little evidence of serious side effects.

A review of various pain management options, including TENS, found it to be well-tolerated. Most users report only minor issues, such as a tingling sensation where the pads are placed. Overall, TENS is considered a safe method for managing pain without significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a TENS unit for pain relief during IUD insertion because it offers a non-invasive, drug-free alternative to standard pain management options like oral painkillers or local anesthesia. The TENS unit works by delivering mild electrical pulses to the skin, which can block pain signals and potentially make the procedure more comfortable. This method could be particularly appealing to those looking for a more natural approach to pain relief without the side effects associated with medications.

What evidence suggests that the TENS unit is effective for pain relief during IUD insertion?

Research has shown that using a TENS (Transcutaneous Electrical Nerve Stimulation) unit may help reduce pain during IUD insertion. In this trial, participants can choose to use a TENS unit during their procedure. Studies have found TENS effective for treating sudden pain, such as the discomfort during this procedure. A series of cases exploring TENS devices found them helpful in reducing pain during IUD insertion. Another study compared TENS to a placebo and found that TENS effectively controlled pain during IUD procedures. Overall, this evidence suggests that TENS units could make the IUD insertion process more comfortable. ^{1 5 6 7 8}

Who Is on the Research Team?

Andrea Zuckerman, MD

Principal Investigator

Tufts Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who are planning to have an IUD (intrauterine device) inserted and are interested in trying a TENS (transcutaneous electrical nerve stimulation) unit for pain relief during the procedure. Participants will be screened over the phone or at Tufts GYN clinic.

Inclusion Criteria

I am between 12 and 50 years old.

I can understand and agree to the study's terms.

Persons with a uterus desiring insertion of intrauterine device

Exclusion Criteria

Prior IUD insertion

Contraindication to intrauterine device (IUD): Postpartum endometritis or infected abortion in the past 3 months

I cannot use an IUD due to having acute pelvic inflammatory disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (phone or in-person)

Treatment

Participants undergo IUD insertion with or without the use of a TENS unit, and pain scores are recorded at various time points during the procedure.

1 day

1 visit (in-person)

Follow-up

Participants complete a post-IUD insertion survey to assess pain management and procedure experience.

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TENS Unit

Trial Overview The study is testing if using a TENS unit can help reduce pain during IUD insertion compared to standard care, which may include NSAIDs, paracervical block, and heating pads. Pain scores will be recorded at various stages of the insertion process.

How Is the Trial Designed?

Group I: TENS unit Experimental Treatment 1 Intervention

Patients who choose to use a TENS unit for their IUD insertion procedure

Group II: Standard care Active Control 1 Intervention

Patients who decline to use a TENS unit for their IUD insertion procedure

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Published Research Related to This Trial

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive and effective method for pain relief, particularly in obstetrics and gynecology, where it has been shown to alleviate labor pain and treat primary dysmenorrhea.

Despite the development of new TENS devices that meet clinical requirements, their use remains limited, suggesting a need for greater awareness and encouragement among patients and healthcare providers to utilize this efficient pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) as a pain-relief device in obstetrics and gynecology. Kaplan, B., Rabinerson, D., Pardo, J., et al.[2020]

A systematic review of 19 studies involving 1671 women found that TENS (Transcutaneous Nerve Stimulation) provided limited evidence of pain reduction during labor, with some effectiveness noted when applied to acupuncture points, resulting in fewer women reporting severe pain.

Despite the limited efficacy in pain relief, most women expressed a willingness to use TENS again in future labors, and no adverse events were reported, suggesting it is a safe option for pain management during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Dowswell, T., Bedwell, C., Lavender, T., et al.[2021]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain intensity during or immediately after treatment compared to placebo, based on a systematic review of 381 randomized controlled trials involving over 24,500 participants.

TENS also shows lower pain intensity compared to standard pharmacological and non-pharmacological treatments, with moderate-certainty evidence indicating it is effective and generally safe, as adverse events were mild and similar to those of comparators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). Johnson, MI., Paley, CA., Jones, G., et al.[2022]

In a study of 52 patients who underwent total abdominal hysterectomy with bilateral salpingo-oophorectomy, TENS significantly improved quality of recovery (QoR) scores compared to a sham treatment group.

Patients receiving TENS reported significantly lower dynamic pain scores during coughing, indicating that TENS may effectively manage certain types of postoperative pain, although it did not affect static pain scores or total analgesic consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation on quality of recovery and pain after abdominal hysterectomy. Karaman, S., Karaman, T., Deveci, H., et al.[2022]

In a study involving 102 nulliparous women with primary dysmenorrhea, the new TENS device (Freelady) provided marked pain relief for 56.9% of participants and moderate relief for 30.4%, demonstrating its efficacy in managing menstrual pain.

The device was not only effective but also safe, as many participants either stopped using pain medications entirely or reduced their dosage during the trial, indicating a significant improvement in their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new model of a transcutaneous electrical nerve stimulation device for the management of primary dysmenorrhea. Kaplan, B., Rabinerson, D., Lurie, S., et al.[2018]

A systematic review of 19 randomized controlled trials (RCTs) on transcutaneous electrical nerve stimulation (TENS) for chronic pain found that while active TENS showed positive analgesic outcomes in 10 out of 15 studies compared to inactive controls, the overall evidence is inconclusive due to poor methodological quality and variability in study designs.

The review highlighted a lack of clarity on the optimal stimulation parameters for TENS and emphasized the need for larger, well-designed multi-centre trials to better assess the long-term effectiveness of TENS in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Carroll, D., Moore, RA., McQuay, HJ., et al.[2018]

In a study of 100 women with acute pelvic pain, transcutaneous electrical nerve stimulation (TENS) significantly reduced pain levels by half compared to a sham treatment, indicating its efficacy as a noninvasive pain relief method.

TENS not only alleviated pain but also decreased anxiety, heart rate, and nausea, while improving overall patient satisfaction with care, demonstrating its safety and rapid effectiveness during ambulance transport.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation as prehospital emergency interventional care: treating acute pelvic pain in young women. Barker, R., Lang, T., Steinlechner, B., et al.[2022]

In a study of 65 women undergoing office endometrial biopsy, the combination of transcutaneous electrical nerve stimulation (TENS) and naproxen sodium significantly reduced pain 15 minutes after the procedure compared to naproxen sodium with placebo TENS.

TENS is shown to be a simple, safe, and effective method for pain relief following the biopsy, making it a valuable option for managing discomfort during this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy. Yilmazer, M., Kose, S., Arioz, DT., et al.[2013]

In a pilot study involving 107 patients with modern implantable cardioverter-defibrillators (ICDs), transcutaneous electrical nerve stimulation (TENS) was found to cause only minor and intermittent electromagnetic interference (EMI) in 15.9% of cases, suggesting that TENS may be safer than previously thought for these patients.

The occurrence of EMI was influenced by factors such as the position of the TENS electrodes, higher current intensity, and the specific manufacturer of the ICD, indicating that careful monitoring and testing under a cardiac device specialist's supervision is recommended before using TENS in ICD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of occurrence of electromagnetic interference from the application of transcutaneous electrical nerve stimulation on the sensing function of implantable defibrillators. Suhail Arain, S., Cretnik, A., Huemer, M., et al.[2023]

Transcutaneous electrical nerve stimulation (TENS) showed weak evidence for reducing pain during labor based on a systematic review of eight trials involving 712 women.

While TENS may reduce the likelihood of needing additional pain relief during labor, the overall analgesic effect is not compelling, suggesting that any observed benefits could be due to biases in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in labour pain: a systematic review. Carroll, D., Tramèr, M., McQuay, H., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06335823

Efficacy of Transcutaneous Electrical Nerve Stimulation ... Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11471041/

Use of Transcutaneous Electrical Nerve Stimulation (TENS ... This case series explores the use of TENS devices to reduce pain during IUD insertion. The device has shown efficacy in treating acute and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07044622

Transcutaneous Electrical Nerve Stimulation (TENS) for ... This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion.

4. societyfp.org societyfp.org/awarded_grants/sfp17-ul4/

A randomized controlled trial of transcutaneous electrical ... We propose a randomized controlled trial to assess the utility of transcutaneous electrical nerve stimulation (TENS) to reduce pain with IUD insertion.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07044622/transcutaneous-electrical-nerve-stimulation-tens-for-intrauterine-device-iud-insertion-pain

Transcutaneous Electrical Nerve Stimulation (TENS) for ... This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11569790/

Pain Management During Intrauterine Device Insertion in ... This study found that there was a clinically significant reduction in pain during cervical grasping with average VAS scores of 39 vs 11 for ...

7. withpower.com withpower.com/trial/tens-for-iud-insertion-pain-30877

TENS for IUD Insertion Pain · Info for Participants This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion.

8. acog.org acog.org/clinical/clinical-guidance/clinical-consensus/articles/2025/05/pain-management-for-in-office-uterine-and-cervical-procedures

Pain Management for In-Office Uterine and Cervical ... A systematic review of studies evaluating the use of NSAIDs, opioids, antispasmodics, and transcutaneous electrical nerve stimulation (TENS) ...