What side effects are associated with this type of intervention?

Common treatments for endometriosis include hormonal therapies and nonpharmacologic interventions like TENS. Hormonal therapies, such as estrogen-progestin contraceptives and GnRH agonists/antagonists, can cause side effects like weight gain, mood changes, decreased bone density, and hot flashes. Levonorgestrel intrauterine devices may lead to irregular bleeding and hormonal side effects. TENS, which uses low-level electrical impulses to reduce pain, is generally low-risk but can occasionally cause skin irritation at the site of electrode placement. Acupuncture and spinal cord stimulation are other nonpharmacologic options, with acupuncture being associated with minimal risk and spinal cord stimulation potentially precluding future MRI studies.

What prior FDA approvals exist?

The provided context does not mention any FDA-approved treatments for endometriosis that are similar to Transcutaneous Electrical Nerve Stimulation (TENS) in terms of using electrical impulses to reduce pain. However, it does discuss various hormonal treatments such as GnRH agonists, LNG IUDs, and aromatase inhibitors, which are commonly used for managing endometriosis-related pain. These treatments focus on hormonal regulation rather than electrical stimulation.

What other types of research exist?

Promising novel alternatives to TENS for endometriosis patients include: 1) High-frequency spinal cord stimulation (SCS), which has shown efficacy in treating chronic pain conditions. 2) Sacral nerve stimulation, which can help manage pelvic pain by modulating nerve signals. 3) Acupuncture, which has been studied for its potential to alleviate chronic pain. 4) Pharmacologic options such as neuromodulators and hormonal therapies tailored to reduce endometriosis-related pain.

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Behavioural Intervention

TENS for Endometrial Biopsy Pain

N/A

Waitlist Available

Led By Laura Havrilesky, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of procedure

Summary

This trial is testing whether a TENS device, which sends small electrical impulses through the skin to reduce pain, can help women feel less discomfort during an endometrial biopsy. The study focuses on women undergoing this procedure because there is no standard method to manage the pain. The TENS device works by blocking pain signals and possibly increasing natural pain relief in the body. TENS has been used for over 50 years to manage various types of pain, including chronic and acute pain.

Who is the study for?

This trial is for patients at least 18 years old from Duke's gynecology clinics who are undergoing an outpatient endometrial biopsy. It's not for those with prior TENS experience, skin damage where the TENS would be placed, heart devices like pacemakers, or if they can't follow instructions.

What is being tested?

The study tests if a low-risk device called TENS can reduce pain during an endometrial biopsy. Participants will use this FDA-approved device that sends electrical impulses through the skin to potentially ease discomfort.

What are the potential side effects?

Using the TENS unit is very low-risk but may cause minor skin reactions where the pads are attached. There aren't many side effects reported with its use in various medical situations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after endometrial biopsy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after endometrial biopsy

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after endometrial biopsy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain after Endometrial Biopsy, as measured by Visual Analogue Scale (VAS)

Secondary study objectives

Change in Pain, as measured by Visual Analogue Scale (VAS) across different time intervals

Number of participants who find the intervention acceptable based on survey response

Number of participants who find the intervention tolerable based on survey response

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TENSExperimental Treatment1 Intervention

Participants will be connected to a TENS 7000 that is turned on and working

Group II: Placebo TENSPlacebo Group1 Intervention

Participants will be connected to a TENS 7000 however it will not be connected / will not be working

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS 7000

2022

N/A

~150

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometriosis include hormonal therapies and nonpharmacologic interventions like Transcutaneous Electrical Nerve Stimulation (TENS). Hormonal treatments, such as estrogen-progestin contraceptives, GnRH agonists, and progestins like dienogest, work by suppressing ovulation and reducing estrogen levels, thereby decreasing the growth and activity of endometrial tissue. TENS provides pain relief by sending low-level electrical impulses through the skin, which can interfere with pain signal transmission to the brain. Understanding these mechanisms helps endometriosis patients make informed decisions about managing their symptoms and improving their quality of life.

Evaluation of endometriosis-associated pain and influence of conventional treatment: a systematic review.