40 Participants Needed

TENS for Endometriosis Pain

Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment TENS for endometriosis pain?

Research shows that TENS can help reduce pain in women with chronic pelvic pain and primary dysmenorrhea (painful periods), which are conditions similar to endometriosis. This suggests that TENS might also be effective for managing endometriosis pain.12345

Is TENS safe for treating pain in humans?

Research shows that TENS is generally safe for treating pain, with studies on conditions like dysmenorrhea (painful periods) reporting no side effects.16789

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

TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it provides pain relief without medication by using electrical impulses to stimulate nerves through the skin. This makes it a non-drug option for managing endometriosis pain, which can be particularly beneficial for those who prefer to avoid or cannot use traditional pain medications.136910

What is the purpose of this trial?

The goal of this project is plan to investigate the utility of Transcutaneous Electrical Nerve Stimulators (TENS) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis.

Eligibility Criteria

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Immediate interventionExperimental Treatment1 Intervention
Group II: Delayed InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

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.
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.
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.
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]

References

Effectiveness of complementary pain treatment for women with deep endometriosis through Transcutaneous Electrical Nerve Stimulation (TENS): randomized controlled trial. [2022]
Effects of thermotherapy and transcutaneous electrical nerve stimulation on patients with primary dysmenorrhea: A randomized, placebo-controlled, double-blind clinical trial. [2020]
Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy. [2013]
Transcutaneous electrical neurostimulation relieves primary dysmenorrhea: A randomized, double-blind clinical study versus placebo. [2022]
Effects of Transcutaneous Electrical Nerve Stimulation on Chronic Pelvic Pain in Women: A Systematic Review and Meta-Analysis. [2023]
Treatment of dysmenorrhoea with a new TENS device (OVA). [2007]
Effect of transcutaneous electrical nerve stimulation therapy for the treatment of primary dysmenorrheal. [2022]
Clinical evaluation of a new model of a transcutaneous electrical nerve stimulation device for the management of primary dysmenorrhea. [2018]
Transcutaneous electrical nerve stimulation (TENS) as a relief for dysmenorrhea. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain. [2022]
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