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.
12345Is 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.
12367How 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.
12468Eligibility 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.
+1 more
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.)
+6 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: No TENS unit useActive Control1 Intervention
All subjects will start with 3 months of no TENS use and diary tracking
Group II: TENS unit useActive Control1 Intervention
All subjects will then have 3 months of TENS use during episodes of endometriosis pain flare and diary tracking.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Health Milton S. Hershey Medical CenterHershey, PA
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Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
References
Effectiveness of complementary pain treatment for women with deep endometriosis through Transcutaneous Electrical Nerve Stimulation (TENS): randomized controlled trial. [2022]Evaluate TENS effectiveness as a complementary treatment of chronic pelvic pain and deep dyspareunia in women with deep endometriosis.
Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy. [2013]To evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for decreasing pain related with office endometrial biopsy.
Effectiveness of neuromuscular electrical stimulation for endometriosis-related pain: A protocol of systematic review and meta-analysis. [2022]This study will assess the effectiveness and safety of neuromuscular electrical stimulation (NMES) for endometriosis-related pain (ERP).
Transcutaneous electrical nerve stimulation (TENS) as a pain-relief device in obstetrics and gynecology. [2020]Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological and non-invasive pain-relief method that has been proven effective for a variety of conditions. Electrical therapy has been recognized for a long time but its practical clinical application in the form of TENS has been evaluated only during the last 30 years as a result of several theories on pain. The most known of these with regard to TENS development is the "gate theory", although several others have also played a role. In obstetrics and gynecology, TENS has been found to be effective in alleviating labor pain and in the treatment of primary dysmenorrhea. It has also been used successfully following obstetric and gynecologic surgery. In order to be effective in clinical use for obstetric and gynecologic indications, a TENS device must have certain properties, which are detailed in this review. Although new TENS devices that meet all the necessary requirements have been developed and tested, their use is still far from widespread. Patients and medical staff should be encouraged to try the TENS device for obstetric and gynecologic indications, since it is non-invasive, efficient, and easy to use.
Long-lasting analgesic effect of transcranial direct current stimulation in treatment of chronic endometriosis pain. [2017]Approximately 10-20% of women of reproductive age suffer from endometriosis, with 70-90% of these women reporting chronic pain symptoms that persist during their menstrual cycle. We are presenting a case in which a novel form of noninvasive brain stimulation called transcranial direct current stimulation was used as an intervention in a 32-year-old woman with persistent, chronic pain symptoms caused by endometriosis for 20 years. Ten daily, 20-min sessions of 2-mA anodal transcranial direct current stimulation were applied over the left primary motor cortex. Acutely, visual analog scale pain symptoms were reduced by 60%. There were also significant decreases in modules of the Endometriosis Health Profile. At the 4-month follow-up, the patient still expressed an overall decrease in pain symptoms of 30%.
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) has been proven effective in pain relief of primary dysmenorrhea (PD). We evaluated the efficacy of a new TENS device (Freelady, Life Care, Tiberias, Israel), designed to correct disadvantages of older models used in previous studies, in 102 nulliparous women with PD, who were treated with various types of pain relief medications. Marked pain relief was reported by 58 patients (56.9%) and moderate relief by 31 (30.4%). These subjective findings were supported by the fact that the same number of patients (58 and 31) either stopped analgesic use altogether during the trial or reduced the quantity of analgesics, respectively. The device examined proved to be efficient and safe in controlling the pain and disability caused by PD.
Transcutaneous electrical nerve stimulation (TENS) as a relief for dysmenorrhea. [2020]Sixty-one women who suffered from primary dysmenorrhea, were treated with Transcutaneous Nerve Stimulation (TENS) for two menstrual cycles, and reported the effect of the treatment on their pain. Thirty percent of the patients reported marked pain relief, 60% reported moderate pain relief and 10% reported that TENS had no influence on their pain. No side effects were reported. We conclude that TENS is an effective and safe non-pharmacological means for the treatment of primary dysmenorrhea. It could serve as a main treatment modality for women who suffer from primary dysmenorrhea and do not wish to or cannot use the conservative pharmacological agents. In addition TENS can serve as an adjuvant therapy to the conventional pharmacological agent in severe cases of primary dysmenorrhea.
The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain. [2022]Transcutaneous electrical nerve stimulation (TENS) is an established method for pain relief in dysmenorrhea. A feasible advantage would be the study of a portable device. The purpose of the study was to evaluate the effectiveness and safety of a new portable TENS device (TANYX®) for menstruation cramps.