Use of TENS Unit in the Management of Endometriosis Pain

NCT05348005 | Completed FDA Device

• 1 other identifier: STUDY00019024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Average Daily VAS Pain Score

  Average daily pain during endometriosis flares will be measured using a Visual Analog Scale (VAS), a horizontal line measuring pain from 0 (no pain) to 100 (worst pain), and compared between the baseline period (no TENS use) and treatment period (TENS use).

  Baseline Period (months 1-3) and Treatment Period (months 4-6)

Secondary Outcomes (2)

• Change in Quality of Life Score from baseline to end of study using the EHP30 questionnaire

  Baseline and 6 months

• Change in Female Sexual Function Index Total Score using the FSFI questionnaire

  Baseline and 6 months

Study Arms (2)

No TENS unit use

NO INTERVENTION

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

TENS unit use

ACTIVE COMPARATOR

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

Device: Ovira Transcutaneous Electrical Nerve Stimulation Unit

Interventions

Ovira Transcutaneous Electrical Nerve Stimulation Unit DEVICE

TENS units have a wide application from treatment of chronic back pain, chronic abdominal pain, cancer pain, perioperative pain, and labor pain.19-24 TENS units have been shown to be well-tolerated with minimal side effects and have been successful in reducing pain as well as pain medication use in patients with primary dysmenorrhea, which excludes pathology such as endometriosis. 11-18 Certain TENS units have also been FDA approved for the general indication of pelvic pain.

TENS unit use

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females ages 18-45 years at time of enrollment
• A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
• Average monthly endometriosis pain flare
• Naïve TENS user

You may not qualify if:

• Implantable devices (pacemaker, Interstim, etc.)
• Cardiac arrhythmia
• Open skin sores over areas of placement
• Pregnancy
• Nursing or trying to conceive at this time
• Post-operative \<12 weeks from abdominal or pelvic surgery
• Planned surgery or hormonal medication changes for duration of study if applicable
• Non-English speaking or inability to read and understand English
• Prisoners

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (24)

• Burney RO, Giudice LC. Pathogenesis and pathophysiology of endometriosis. Fertil Steril. 2012 Sep;98(3):511-9. doi: 10.1016/j.fertnstert.2012.06.029. Epub 2012 Jul 20.

  PMID: 22819144 RESULT

• Bai HY, Bai HY, Yang ZQ. Effect of transcutaneous electrical nerve stimulation therapy for the treatment of primary dysmenorrheal. Medicine (Baltimore). 2017 Sep;96(36):e7959. doi: 10.1097/MD.0000000000007959.

  PMID: 28885348 RESULT

• Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.

  PMID: 15541453 RESULT

• Lamvu G, Soliman AM, Manthena SR, Gordon K, Knight J, Taylor HS. Patterns of Prescription Opioid Use in Women With Endometriosis: Evaluating Prolonged Use, Daily Dose, and Concomitant Use With Benzodiazepines. Obstet Gynecol. 2019 Jun;133(6):1120-1130. doi: 10.1097/AOG.0000000000003267.

  PMID: 31135725 RESULT

• Coxon L, Horne AW, Vincent K. Pathophysiology of endometriosis-associated pain: A review of pelvic and central nervous system mechanisms. Best Pract Res Clin Obstet Gynaecol. 2018 Aug;51:53-67. doi: 10.1016/j.bpobgyn.2018.01.014. Epub 2018 Feb 15.

  PMID: 29525437 RESULT

• Rocha MG, e Silva JC, Ribeiro da Silva A, Candido Dos Reis FJ, Nogueira AA, Poli-Neto OB. TRPV1 expression on peritoneal endometriosis foci is associated with chronic pelvic pain. Reprod Sci. 2011 Jun;18(6):511-5. doi: 10.1177/1933719110391279. Epub 2010 Dec 15.

  PMID: 21160085 RESULT

• O'Hara R, Rowe H, Fisher J. Self-management in condition-specific health: a systematic review of the evidence among women diagnosed with endometriosis. BMC Womens Health. 2019 Jun 19;19(1):80. doi: 10.1186/s12905-019-0774-6.

  PMID: 31216998 RESULT

• Armour M, Sinclair J, Chalmers KJ, Smith CA. Self-management strategies amongst Australian women with endometriosis: a national online survey. BMC Complement Altern Med. 2019 Jan 15;19(1):17. doi: 10.1186/s12906-019-2431-x.

  PMID: 30646891 RESULT

• Goncalves AV, Makuch MY, Setubal MS, Barros NF, Bahamondes L. A Qualitative Study on the Practice of Yoga for Women with Pain-Associated Endometriosis. J Altern Complement Med. 2016 Dec;22(12):977-982. doi: 10.1089/acm.2016.0021. Epub 2016 Aug 23.

  PMID: 27552065 RESULT

• Huijs E, Nap A. The effects of nutrients on symptoms in women with endometriosis: a systematic review. Reprod Biomed Online. 2020 Aug;41(2):317-328. doi: 10.1016/j.rbmo.2020.04.014. Epub 2020 May 15.

  PMID: 32600946 RESULT

• Leonardi M, Horne AW, Vincent K, Sinclair J, Sherman KA, Ciccia D, Condous G, Johnson NP, Armour M. Self-management strategies to consider to combat endometriosis symptoms during the COVID-19 pandemic. Hum Reprod Open. 2020 Jun 1;2020(2):hoaa028. doi: 10.1093/hropen/hoaa028. eCollection 2020.

  PMID: 32509977 RESULT

• Schiotz HA, Jettestad M, Al-Heeti D. Treatment of dysmenorrhoea with a new TENS device (OVA). J Obstet Gynaecol. 2007 Oct;27(7):726-8. doi: 10.1080/01443610701612805.

  PMID: 17999304 RESULT

• Vance CG, Dailey DL, Rakel BA, Sluka KA. Using TENS for pain control: the state of the evidence. Pain Manag. 2014 May;4(3):197-209. doi: 10.2217/pmt.14.13.

  PMID: 24953072 RESULT

• Lauretti GR, Oliveira R, Parada F, Mattos AL. The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain. Neuromodulation. 2015 Aug;18(6):522-6; discussion 522-7. doi: 10.1111/ner.12269. Epub 2015 Feb 5.

  PMID: 25655828 RESULT

• Machado AFP, Perracini MR, Rampazo EP, Driusso P, Liebano RE. Effects of thermotherapy and transcutaneous electrical nerve stimulation on patients with primary dysmenorrhea: A randomized, placebo-controlled, double-blind clinical trial. Complement Ther Med. 2019 Dec;47:102188. doi: 10.1016/j.ctim.2019.08.022. Epub 2019 Aug 28.

  PMID: 31779988 RESULT

• Igwea SE, Tabansi-Ochuogu CS, Abaraogu UO. TENS and heat therapy for pain relief and quality of life improvement in individuals with primary dysmenorrhea: A systematic review. Complement Ther Clin Pract. 2016 Aug;24:86-91. doi: 10.1016/j.ctcp.2016.05.001. Epub 2016 May 7.

  PMID: 27502806 RESULT

• Kannan P, Claydon LS. Some physiotherapy treatments may relieve menstrual pain in women with primary dysmenorrhea: a systematic review. J Physiother. 2014 Mar;60(1):13-21. doi: 10.1016/j.jphys.2013.12.003. Epub 2014 Apr 24.

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  PMID: 23641031 RESULT

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• Hurlow A, Bennett MI, Robb KA, Johnson MI, Simpson KH, Oxberry SG. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006276. doi: 10.1002/14651858.CD006276.pub3.

  PMID: 22419313 RESULT

• Johnson MI. Transcutaneous electrical nerve stimulation (TENS) as an adjunct for pain management in perioperative settings: a critical review. Expert Rev Neurother. 2017 Oct;17(10):1013-1027. doi: 10.1080/14737175.2017.1364158. Epub 2017 Aug 24.

  PMID: 28817978 RESULT

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  PMID: 11869624 RESULT

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin W Riley, MD

  Penn State Health Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Obstetrics and Gynecology; Interim Chief, Minimally Invasive Gynecologic Surgery; Fellowship Program Director, Minimally Invasive Gynecologic Surgery

Model Details: cross-over clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-month "baseline" period (no TENS unit use for endometriosis flares) and then cross-over to a 3-month "treatment" period (TENS unit use for endometriosis flares).

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: April 27, 2022
• Study Start: July 28, 2022
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)