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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.

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 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 the pain relief to be good or very good, while 42% noticed some effect. These results suggest that TENS can be a useful method for managing pain, as it has been effective in similar situations without causing complications. ^{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 on mothers or fetuses. It is considered a non-addictive, non-invasive, and safe method for pain management. A systematic review of 381 studies also supports its safety for acute and chronic pain in adults. ^{1 3 4 6 7}

Is TENS a promising treatment for pain during IUD insertion?

Yes, TENS is a promising treatment for pain during IUD insertion. It is a non-drug method that uses mild electrical currents to relieve pain. TENS is easy to use, portable, and has been effective in reducing pain in various medical situations, including childbirth and gynecological procedures. Many people find it helpful, and it doesn't have the side effects that some pain medications do. ^{1 3 4 8 9}

Research Team

Jean M Marino, APRN-CNP

Principal Investigator

University Hospitals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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 (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 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]

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]

References

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

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

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. England pubmed.ncbi.nlm.nih.gov

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

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]