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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.

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 data supports the effectiveness of the treatment Ovira Transcutaneous Electrical Nerve Stimulation Unit for endometriosis pain?

Research shows that Transcutaneous Electrical Nerve Stimulation (TENS) is effective in reducing pain for various gynecological conditions, including labor pain and primary dysmenorrhea (painful periods). It has also been used successfully for pain relief in women undergoing procedures like endometrial biopsy, suggesting it may help with endometriosis pain as well. ^{1 2 3 4 5}

Is TENS safe for treating pain in humans?

TENS has been reported as safe in studies for conditions like primary dysmenorrhea, with no side effects noted in participants. ^{1 2 3 6 7}

How does TENS treatment differ from other treatments for endometriosis pain?

TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it is a non-drug, non-invasive method that uses electrical impulses to relieve pain, unlike traditional medications. It is easy to use and has been effective in managing pain for various gynecological conditions, making it a promising option for endometriosis pain. ^{1 2 4 6 8}

Research Team

Kristin Riley, MD

Principal Investigator

Penn State Health Hershey Medical Center

Eligibility Criteria

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.

TENS device exclusion: Implantable devices (pacemaker, Interstim, etc.)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of complementary pain treatment for women with deep endometriosis through Transcutaneous Electrical Nerve Stimulation (TENS): randomized controlled trial. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

Effectiveness of neuromuscular electrical stimulation for endometriosis-related pain: A protocol of systematic review and meta-analysis. [2022]

4. Singapore pubmed.ncbi.nlm.nih.gov

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

5. Australia pubmed.ncbi.nlm.nih.gov

Long-lasting analgesic effect of transcranial direct current stimulation in treatment of chronic endometriosis pain. [2017]

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. Singapore pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) as a relief for dysmenorrhea. [2020]

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

The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain. [2022]