TENS for Endometriosis Pain

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Males, No endometriosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Transcutaneous Electrical Nerve Stimulators (TENS) can reduce pain and improve the quality of life for individuals with endometriosis-related chronic pelvic pain. TENS devices send small electrical pulses through the skin to manage pain. Participants will be divided into two groups: one will start using TENS immediately, while the other will begin later. Adolescents or young adults diagnosed with endometriosis, experiencing pelvic pain for at least half of each month, and having access to a smartphone might be suitable for this trial. As an unphased trial, this study offers the opportunity to contribute to understanding how TENS can benefit those with chronic pelvic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that TENS (Transcutaneous Electrical Nerve Stimulation) is generally safe for treating pain. In studies, individuals using TENS for endometriosis reported very few side effects, often experiencing pain relief and requiring less pain medication. Another study found that TENS is easy to use and did not cause major side effects. In cases such as painful periods, no side effects were reported. Overall, TENS appears to be a safe option for managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcutaneous Electrical Nerve Stimulation (TENS) for endometriosis pain because it offers a non-invasive approach to pain relief, unlike many current treatments such as hormonal therapies or pain medications that can have significant side effects. TENS works by sending mild electrical pulses through the skin to help block pain signals and promote the release of endorphins, offering a drug-free alternative. This method can be particularly appealing for those seeking to avoid the hormonal or systemic side effects associated with traditional medications. Additionally, TENS can be used alongside other treatments, giving patients more flexibility in managing their symptoms.

What evidence suggests that TENS is effective for endometriosis pain?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) can help reduce pain in individuals with conditions like endometriosis. Studies have found that both acupuncture-like TENS and self-applied TENS can significantly lessen chronic pelvic pain and improve quality of life. In this trial, participants will join either an immediate intervention group or a delayed intervention group to evaluate TENS's effectiveness. Some studies have demonstrated that using TENS leads to noticeable pain relief compared to no treatment. This suggests that TENS could be a promising option for managing pain associated with endometriosis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adolescent girls and young women aged 13-25 who have been diagnosed with endometriosis and are experiencing significant pelvic pain (score of at least 3 out of 10) for most days over the past two months. Participants must own a smartphone or mobile device and speak English or Spanish.

Inclusion Criteria

Personal smart phone or mobile device

I am a female aged between 13 and 25.

I have been diagnosed with endometriosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transcutaneous Electrical Nerve Stimulators (TENS) for pain reduction and quality of life improvement

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TENS

Trial Overview The study is examining how effective Transcutaneous Electrical Nerve Stimulators (TENS) are in reducing chronic pelvic pain and enhancing life quality in adolescents and young adults suffering from endometriosis-related discomfort.

How Is the Trial Designed?

Group I: Immediate intervention Experimental Treatment 1 Intervention

Group II: Delayed Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

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]

The portable TENS device (TANYX®) provided significant pain relief for dysmenorrhea, reducing mean pain scores from 8 to 2 cm on a visual analog scale, indicating its efficacy in managing menstrual cramps.

Participants using the active TENS device reported improved quality of life, including better daily functioning and reduced need for pain medication, with no adverse effects noted during the study involving 40 women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain. Lauretti, GR., Oliveira, R., Parada, F., et al.[2022]

A randomized controlled trial involving 22 women with deep endometriosis showed that both acupuncture-like TENS and self-applied TENS significantly reduced chronic pelvic pain and deep dyspareunia after 8 weeks of treatment.

Both TENS methods improved the quality of life for participants, indicating that TENS can be an effective complementary treatment for managing pain associated with deep endometriosis, even in women already undergoing hormone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of complementary pain treatment for women with deep endometriosis through Transcutaneous Electrical Nerve Stimulation (TENS): randomized controlled trial. Mira, TA., Giraldo, PC., Yela, DA., et al.[2022]

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 study of 61 women with primary dysmenorrhea, Transcutaneous Nerve Stimulation (TENS) provided significant pain relief, with 30% experiencing marked relief and 60% reporting moderate relief, indicating its efficacy as a treatment option.

TENS was found to be a safe, non-pharmacological alternative for managing menstrual pain, with no reported side effects, making it suitable for women who prefer to avoid medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) as a relief for dysmenorrhea. Kaplan, B., Peled, Y., Pardo, J., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26319650/

Effectiveness of complementary pain treatment for women ... We observed significant improvement for chronic pelvic pain, deep dyspareunia and quality of life by the use of TENS. Both application types of TENS were ...

2. withpower.com withpower.com/trial/phase-endometriosis-4-2022-53d9d

TENS for Endometriosis Pain A randomized controlled trial involving 22 women with deep endometriosis showed that both acupuncture-like TENS and self-applied TENS significantly reduced ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05348005

Use of TENS Unit in the Management of Endometriosis Pain The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain.

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013331.pub2/abstract

Transcutaneous electrical nerve stimulation (TENS) for ... High‐frequency TENS may reduce pain compared with placebo or no treatment (mean difference (MD) −1.39, 95% confidence interval (CI) −2.51 to − ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211515002468

Effectiveness of complementary pain treatment for women ... Our results demonstrated the effectiveness of acupuncture-like TENS and self-applied TENS as complementary treatment of chronic pelvic pain and deep ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456919302871

Review – Pelvic Pain Benefits and Harms of Electrical ... Effectiveness of complementary pain treatment for women with deep endometriosis through transcutaneous electrical nerve stimulation (TENS): ...

7. posters.worldcongress2024.org posters.worldcongress2024.org/poster/patients-experiences-of-transcutaneous-electrical-nerve-stimulation-for-endometriosis-related-pain/

Patients' Experiences of Transcutaneous Electrical Nerve ... Patients with endometriosis-related pain experienced satisfying pain relief from TENS treatment, leading to increased PA and improved everyday ...

8. withpower.com withpower.com/trial/phase-endometriosis-8-2025-13b23

TENS for Endometriosis Pain · Info for Participants Research shows that TENS is generally safe for treating pain, with studies on conditions like dysmenorrhea (painful periods) reporting no side effects. Show ...