TENS for IUD Insertion Pain

Overseen By Jean M Marino, APRN-CNP

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Jean Marino

Must not be taking: Analgesics

Disqualifiers: Pacemaker, IUD contraindications, others

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

Compensation: Varies

Number of Visits: 1

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 a TENS unit can reduce pain during IUD insertions. The TENS unit uses mild electric pulses to ease discomfort. Participants will use either an active TENS unit or a non-active one for comparison. Suitable candidates for this trial include individuals with a cervix and uterus planning to get an IUD for birth control or to manage abnormal bleeding. As an unphased trial, this study allows participants to contribute to innovative pain management research.

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

The trial protocol does not specify if you need to stop taking your current medications, but you cannot use analgesics within 4 hours before the IUD placement.

What prior data suggests that TENS is safe for reducing IUD insertion pain?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) is generally safe. Studies have examined TENS for various types of pain, including during childbirth, and have not found any side effects for mothers or their babies, suggesting that TENS is well-tolerated.

TENS has also been studied for reducing pain during IUD insertion. Results from these studies indicate that TENS can effectively relieve pain without causing negative effects. Therefore, for those considering joining a trial using TENS, existing research supports its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcutaneous Electrical Nerve Stimulation (TENS) for reducing pain during IUD insertion because it offers a non-drug, non-invasive option. Unlike standard care methods that might involve oral pain relievers or topical anesthetics, TENS works by sending electrical impulses through the skin, which can help block pain signals to the brain. This approach not only aims to provide immediate relief but also minimizes the risk of side effects typically associated with medications. The potential for a simple, device-based method to make IUD insertions more comfortable is what makes this trial particularly promising.

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

Research shows that a TENS device can help reduce pain during IUD insertions. TENS, or Transcutaneous Electrical Nerve Stimulation, uses mild electrical currents to relieve pain. In this trial, participants will join one of two groups: one will receive an active TENS unit, while the other will receive a non-active TENS unit as a placebo comparator. Studies have found that people using an active TENS device report lower pain levels on a scale from 0 (no pain) to 10 (worst pain). Specifically, one report noted that patients felt less pain with TENS than they usually would during an IUD insertion. Other studies also support its effectiveness in managing sudden pain. Overall, these findings suggest TENS could be a helpful option for pain relief during IUD procedures. ^{1 4 5 6 7}

Who Is on the Research Team?

Jean M Marino, APRN-CNP

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

This trial is for individuals experiencing pain during IUD insertion. Participants should be those seeking an IUD placement and willing to try a non-invasive pain control method. Specific eligibility details are not provided, but typically include age range, health status, and no contraindications for TENS.

Inclusion Criteria

Ability to use the visual analogue scale (VAS)

I have both a cervix and uterus.

I am medically cleared to have an IUD placed.

Exclusion Criteria

Contraindications to IUD placement

I have taken pain medication within 4 hours before my IUD placement.

Presence of a pacemaker

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 non-active TENS unit during IUD insertion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels during and immediately after IUD insertion

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Nerve Stimulation (TENS)

Trial Overview The study is testing the effectiveness of TENS—a non-invasive procedure that uses electrical currents to reduce pain—against a placebo version during IUD insertions in outpatient gynecology settings.

How Is the Trial Designed?

Group I: Active TENS unit Experimental Treatment 1 Intervention

All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.

Group II: Non-active TENS unit Placebo Group 1 Intervention

All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit 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?

Jean Marino

Lead Sponsor

Trials

1

Recruited

60+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Published Research Related to This Trial

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 (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]

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 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]

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 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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06335823

Efficacy of Transcutaneous Electrical Nerve Stimulation ... Pain during IUD insertion as measured by the VAS score, The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable, 5 minute ...

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. 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 ...

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

TENS for IUD Insertion Pain · Info for Participants 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 ...

7. trial.medpath.com trial.medpath.com/clinical-trial/a1f7654a02bf81db/nct06245655-randomized-trial-tens-iud-pain

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