TENS for Endometriosis Pain

Overseen By Kristin Riley, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Pregnancy, Cardiac arrhythmia, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a TENS (Transcutaneous Electrical Nerve Stimulation) unit can reduce pain from endometriosis flare-ups. Participants will track their pain and symptoms for three months without the device, followed by three months using the TENS unit. Women with a confirmed diagnosis of endometriosis, who experience monthly pain flares and have never used a TENS unit, might be suitable for this trial. The study seeks to understand if this non-invasive device can provide relief from endometriosis pain. As an unphased trial, it offers participants the chance to contribute to valuable research that could lead to new pain management options for endometriosis.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you will need to record your medication use in an online diary during the study.

What prior data suggests that this TENS unit is safe for endometriosis pain relief?

Research shows that TENS units, devices used to relieve pain, are generally safe. Studies have found that TENS can reduce pain without causing serious side effects. However, one report described a person experiencing a severe shock, which caused pain in their leg. TENS units are approved for pain relief in areas like the lower back, arms, and legs, indicating they are usually well-tolerated for managing pain. Overall, most people use TENS units without major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Ovira Transcutaneous Electrical Nerve Stimulation (TENS) unit for endometriosis pain because it offers a drug-free, non-invasive approach to managing discomfort. Unlike common treatments like hormonal therapies or pain medications, which can have significant side effects or long-term impacts, the TENS unit uses electrical impulses to disrupt pain signals directly. This method provides immediate relief during pain flares without the systemic effects of traditional medications. Plus, it empowers patients with a portable solution, potentially improving quality of life by allowing them to manage pain on-the-go.

What evidence suggests that the TENS unit is effective for endometriosis pain?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) can help reduce pain from endometriosis. One study with 22 women found that TENS significantly lessened pain from deep endometriosis. Another study found TENS to be a useful additional treatment for ongoing pelvic pain linked to endometriosis. In this trial, participants will first experience a period without TENS unit use, followed by a period of TENS unit use during episodes of endometriosis pain flare. TENS, a type of electrotherapy, has proven effective in controlling pain. Overall, TENS may help manage endometriosis pain by interrupting pain signals in the body. ^{1 3 6 7 8}

Who Is on the Research Team?

Kristin Riley, MD

Principal Investigator

Penn State Health Hershey Medical Center

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 who have been diagnosed with endometriosis through surgery or tissue examination, experience monthly pain flares from it, and have never used a TENS unit. It's not for those with pacemakers, heart rhythm problems, open skin sores where the device goes, or if pregnant/nursing/trying to conceive. Participants must speak and understand English.

Inclusion Criteria

My endometriosis was confirmed through surgery or biopsy.

I experience frequent endometriosis pain flares monthly.

I am a woman aged between 18 and 45.

Exclusion Criteria

I had surgery in my abdomen or pelvis less than 12 weeks ago.

I am not planning any surgery or changes to my hormonal medications during the study.

I do not have an irregular heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants record pain, medication use, and bleeding in an online diary during endometriosis flare-ups for 3 months without using the TENS unit

3 months

Remote diary entries

Treatment

Participants use the TENS unit and record pain, medication use, and bleeding in an online diary during endometriosis flare-ups for an additional 3 months

3 months

Remote diary entries

Follow-up

Participants complete a QOL and FSFI survey to assess changes in quality of life and sexual function

1-2 weeks

Remote survey completion

What Are the Treatments Tested in This Trial?

Interventions

• Ovira Transcutaneous Electrical Nerve Stimulation Unit

Trial Overview The study tests whether a TENS (Transcutaneous Electrical Nerve Stimulation) unit can reduce pain during endometriosis flare-ups. For three months participants will track their pain without the device; then they'll use the TENS unit for another three months while recording their symptoms.

How Is the Trial Designed?

Group I: No TENS unit use Active Control 1 Intervention

All subjects will start with 3 months of no TENS use and diary tracking

Group II: TENS unit use Active Control 1 Intervention

All subjects will then have 3 months of TENS use during episodes of endometriosis pain flare and diary tracking.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

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]

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]

This study aims to systematically review and analyze randomized controlled trials (RCTs) to determine the effectiveness and safety of neuromuscular electrical stimulation (NMES) for treating endometriosis-related pain, which is a common and debilitating condition.

The findings from this systematic review will help inform clinicians and guide future research on NMES as a potential treatment option for managing pain associated with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of neuromuscular electrical stimulation for endometriosis-related pain: A protocol of systematic review and meta-analysis. Zhang, ZY., Wang, J., Fan, YL., et al.[2022]

Transcranial direct current stimulation (tDCS) was used as a noninvasive treatment for a 32-year-old woman with chronic pain from endometriosis, resulting in a 60% reduction in pain symptoms after 10 sessions.

At a 4-month follow-up, the patient reported a sustained 30% decrease in pain, indicating that tDCS may provide long-term relief for chronic pain associated with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-lasting analgesic effect of transcranial direct current stimulation in treatment of chronic endometriosis pain. Rostami, R., Badran, BW., Kazemi, R., et al.[2017]

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 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]

Citations

1. 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 ...

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

Effectiveness of complementary pain treatment for women ... Objective: Evaluate TENS effectiveness as a complementary treatment of chronic pelvic pain and deep dyspareunia in women with deep endometriosis.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05348005/use-of-tens-unit-in-the-management-of-endometriosis-pain

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33129015/

Hormonal treatment isolated versus ... Conclusions: Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing ...

5. trial.medpath.com trial.medpath.com/clinical-trial/06bd66b462570bc5/nct05152264-high-frequency-high-intensity-transcutaneous-electrical-nerve-stimulation-endometriosis-chronic

Transcutaneous Electrical Nerve Stimulation for ... - MedPath All patients in the study will receive TENS treatment for a total of 16 weeks, for evaluation of long-term effects of TENS treatment in chronic endometriosis- ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=12607175&pc=NUH

EASYMED INSTRUMENTS CO. LTD OVIRA The customer reported severe shock from the device resulting in pain down her left leg, hip and foot.For context, the device comes in two components: 1) the ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35144946/

Efficacy and safety of transcutaneous electrical nerve ... There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06019091

Study Details | NCT06019091 | Optimal Frequency Used in ... This study aims to find the optimal frequency, also known as cycles per second or Hertz (Hz) for treating chronic pelvic pain using non-invasive skin-level ...