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

Trial Summary

What is the purpose of this trial?

Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. The patient will decide if they desire to use TENS unit during IUD insertion appointment and inform the study team. The clinic visit will proceed as normal, with additional study proceedings as follows. The study personnel will complete the 'Background Questionnaire' with the patient prior to IUD insertion. During the IUD insertion appointment, study personnel will assist in collection of the 'Study visit' data collection form. This includes recording the patient's pain score at various time points throughout the insertion procedure: * anticipated pain during IUD insertion * baseline pain prior to insertion * speculum insertion * tenaculum placement * paracervical block administration (if performed) * cervical dilation (if performed) * uterine sounding * IUD insertion * 5 minutes after IUD insertion Study personnel will also time the insertion procedure and collect additional data as outlined in the 'Study visit data collection form.' After IUD insertion, the participant will be asked to complete the 'Post-IUD Insertion Survey.' Once this survey is complete, this will conclude the study participation. Participation will last through the study visit only. As part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to IUD insertion. Patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include NSAID administration, paracervical block, and heating pad.

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

The available research shows that TENS, a treatment using electrical impulses, is effective in reducing pain for various conditions in obstetrics and gynecology. It has been successful in alleviating labor pain, treating menstrual cramps, and managing pain after surgeries like hysterectomy. In a study on acute pelvic pain, women using TENS reported their pain was reduced by half compared to those who did not use it. This suggests that TENS could be a helpful option for pain relief during IUD insertion as well. ^{1 2 3 4 5}

What safety data exists for using TENS for pain relief?

The safety of TENS has been evaluated in various studies. A systematic review and meta-analysis of 381 studies confirmed its safety for acute and chronic pain relief in adults. A pilot safety study re-evaluated TENS in patients with modern implantable cardioverter-defibrillators, suggesting that previous concerns about electromagnetic interference may be outdated. Additionally, a clinical evaluation of a new TENS model for primary dysmenorrhea found it to be safe and effective. TENS has also been used safely in obstetrics and gynecology for labor pain and post-surgical pain relief. ^{1 6 7 8 9}

Is TENS a promising treatment for pain relief during IUD insertion?

Yes, TENS is a promising treatment because it is non-invasive, easy to use, and has been effective in reducing pain in various medical situations, including labor and surgery recovery. It can help people feel more in control of their pain management. ^{1 2 3 6 10}

Research Team

Andrea Zuckerman, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

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

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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) 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) 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]

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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

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

2. India pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. [2021]

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

Transcutaneous electrical nerve stimulation as prehospital emergency interventional care: treating acute pelvic pain in young women. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new model of a transcutaneous electrical nerve stimulation device for the management of primary dysmenorrhea. [2018]

7. England 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. [2023]

8. 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]

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

Transcutaneous electrical nerve stimulation in labour pain: a systematic review. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018]