TENS for IUD Insertion Pain

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Lauren Kus, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.

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 data supports the idea that TENS for IUD Insertion Pain is an effective treatment?

The available research shows that TENS is effective in providing pain relief during delivery, which is a similar type of pain management. In one study, 44% of women reported good to very good pain relief, and another 44% experienced moderate relief. In a second study, 47% of women found TENS to be good or very good for pain relief, with 42% experiencing some effect. These results suggest that TENS can be a useful treatment for managing pain, similar to what might be experienced during IUD insertion. ^{1 2 3 4 5}

What safety data exists for TENS treatment?

TENS has been studied for pain relief in various contexts, including labor and delivery, with no reported side effects for mothers or fetuses. A systematic review and meta-analysis of 381 studies also investigated the safety of TENS for acute and chronic pain in adults, suggesting it is a safe method for pain management. ^{1 3 4 6 7}

Is TENS a promising treatment for pain during IUD insertion?

Yes, TENS is a promising treatment for pain relief. It is non-invasive, easy to use, and has been effective in reducing pain in various situations, including childbirth and gynecological procedures. Many people find it helpful, and it doesn't involve drugs, making it a safe option to try. ^{1 3 4 8 9}

Research Team

Lauren Kus, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

Stated willingness to comply with all study procedures

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

I am 18 or older and speak English.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Transcutaneous Electrical Nerve Stimulation (TENS) (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Findings from Research

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Germany pubmed.ncbi.nlm.nih.gov

[Pain relief during delivery by transcutaneous electrical nerve stimulation (author's transl)]. [2013]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Skin impedance is not a factor in transcutaneous electrical nerve stimulation effectiveness. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pain relief during delivery by transcutaneous electrical nerve stimulation. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation on quality of recovery and pain after abdominal hysterectomy. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[The effect of transcutaneous nerve stimulation on labor pain (author's transl)]. [2011]

7. England 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). [2022]

8. Singapore pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) as a pain-relief device in obstetrics and gynecology. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. [2022]