TENS for IUD Insertion Pain

No longer recruiting at 4 trial locations

Overseen By Shanell Morrison, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Opioids, Benzodiazepines, Muscle relaxers, others

Disqualifiers: Pregnancy, Chronic pain, Heart disease, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

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 tests whether a device called TENS (Transcutaneous Electrical Nerve Stimulation) can reduce pain during IUD insertion, a type of birth control. TENS uses electrical impulses to relieve pain without drugs. Participants will be randomly assigned to receive either active TENS treatment or a placebo version (a fake treatment without actual stimulation) during their IUD procedure. Those planning to get an IUD at Mount Sinai, who speak English, and agree to follow the study's steps might be suitable candidates. The study aims to determine if TENS can make IUD insertion more comfortable. As an unphased trial, this study explores a non-drug pain relief method that could enhance comfort during IUD procedures.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have used opioids in the last 30 days or have a contraindication to ibuprofen.

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

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) is generally safe and well-tolerated for pain relief in various situations. One study found that almost half of the participants reported good or very good pain relief with TENS during procedures. As a non-drug option, TENS avoids many side effects associated with medications.

While specific data on side effects is not provided, TENS is known to have a low risk of them. This makes it a promising choice for managing pain, especially during outpatient procedures like IUD insertions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard pain management options for IUD insertion, which often involve oral painkillers like ibuprofen or local anesthesia, Transcutaneous Electrical Nerve Stimulation (TENS) offers a non-drug, non-invasive alternative. TENS works by sending mild electrical pulses through the skin to block pain signals and stimulate endorphin production, potentially reducing pain without medication. This approach is exciting because it allows for customizable intensity levels based on patient comfort, promising a personalized and potentially more comfortable experience during IUD insertion.

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

Research shows that Transcutaneous Electrical Nerve Stimulation (TENS) can help reduce pain during certain medical procedures. TENS sends small electrical impulses through the skin to lessen pain. Previous studies have found that TENS effectively eases pain during various outpatient gynecological procedures. In one study, 44% of women reported good to very good pain relief when using TENS during childbirth. This trial will compare Active TENS, set to 80 Hz, with Placebo TENS, where the device remains off, to evaluate their effectiveness in managing pain during IUD insertion. ^{1 2 3 5 6}

Who Is on the Research Team?

Lauren Kus, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals experiencing pain during IUD insertion. Participants should be those undergoing the procedure and willing to use a TENS device for pain management. Specific eligibility details are not provided, but typically include being of reproductive age and in good general health.

Inclusion Criteria

Presenting for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service

Stated willingness to comply with all study procedures

Provision of signed and dated informed consent form for IUD Insertion

Exclusion Criteria

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

I am allergic to or cannot take ibuprofen.

I have a long-term pain condition.

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 TENS or placebo TENS during IUD insertion

1 day

1 visit (in-person)

Follow-up

Participants complete surveys to rate pain and reflect on their experience with IUD insertion and TENS device

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 to manage pain during IUD insertion. It's a double-blind trial, meaning neither participants nor researchers know who gets real TENS or placebo. Pain levels will be 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.

Transcutaneous Electrical Nerve Stimulation (TENS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Approved in European Union as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Approved in Canada as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

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]

Transcutaneous electrical nerve stimulation (TNS) was evaluated for pain relief during delivery in a study involving 347 women, with 47% reporting good or very good analgesia and 42% noting some effect.

The method was found to be safe, with no complications reported for either mothers or babies, suggesting TNS can be recommended as a primary pain relief option during childbirth, potentially used alongside conventional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pain relief during delivery by transcutaneous electrical nerve stimulation (author's transl)]. Bundsen, P., Carlsson, CA., Forssman, L., et al.[2013]

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]

Lower skin impedance was found at optimal electrode sites for TENS treatment, suggesting that these sites may enhance the effectiveness of pain management techniques.

In a study with 24 healthy volunteers, both optimal and sham TENS treatments significantly increased pressure pain thresholds compared to a placebo, indicating that TENS is effective for pain relief, regardless of skin impedance at the electrode sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin impedance is not a factor in transcutaneous electrical nerve stimulation effectiveness. Vance, CG., Rakel, BA., Dailey, DL., et al.[2022]

Transcutaneous electrical nerve stimulation (TNS) was evaluated for pain relief during delivery in 147 women, with 44% reporting good to very good pain relief and another 44% experiencing moderate effects, indicating its efficacy as a pain management option.

The modified TNS technique showed no complications for either the mother or child, suggesting it is a safe primary pain relief method that can be used alongside conventional approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain relief during delivery by transcutaneous electrical nerve stimulation. Augustinsson, LE., Bohlin, P., Bundsen, P., et al.[2021]

A systematic review included 12 randomized controlled trials with 919 participants to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for treating acute pain, but insufficient data prevented definitive conclusions.

The review highlighted that many studies were excluded because TENS was used alongside other treatments, indicating a need for more focused research on TENS as a standalone therapy for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. Walsh, DM., Howe, TE., Johnson, MI., et al.[2022]

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]

Transcutaneous electrical nerve stimulation (TENS) is a non-addictive and non-invasive pain relief method that is easy to use and portable, making it suitable for various conditions.

TENS provides continuous analgesia, and the article reviews its efficacy and potential applications in clinical practice, highlighting its benefits as a pain management tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the evidence for using TENS to relieve pain. Wright, A.[2012]

In a study of 102 women using transcutaneous electric nerve stimulation (TNS) during delivery, over half (55.9%) reported good to very good pain relief, indicating its efficacy as a pain management technique.

TNS was found to have no adverse effects on either the mother or fetus, and it contributed to a quicker delivery without obstetrical complications, supporting its designation as a safe and effective method for pain relief during childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of transcutaneous nerve stimulation on labor pain (author's transl)]. Kubista, E., Kucera, H., Riss, P.[2011]

Citations

1. 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.

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. 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.

4. 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.

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

TENS for IUD Insertion Pain · Info for Participants Transcutaneous electrical nerve stimulation (TNS) was evaluated for pain relief during delivery in 147 women, with 44% reporting good to very good pain relief ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39398805/

Use of Transcutaneous Electrical Nerve Stimulation (TENS ... She rated overall pain during the procedure as 20 mm. All patients reported lower pain scores when compared to previously reported median pain ...