Use of TENS Unit in the Management of Endometriosis Pain

NCT05348005 | Completed Results 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

  Daily pain during endometriosis flares were recorded using a Visual Analog Scale (VAS), a horizontal line measuring pain from 0 (no pain) to 100 (worst pain). Per subject, an average pain score was calculated for the baseline period (no TENS use) and treatment period (TENS use). Change (treatment minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents worse outcome, change in the negative direction represents improvement.

  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 end of study (6 months)

• Change in Female Sexual Function Index (FSFI) Total Score From Baseline to End of Study

  Baseline and end of study (6 months)

Study Arms (1)

Study Cohort for TENS

OTHER

Subjects will be observed for 3 months (no intervention) during which time they will track endometriosis flares, followed by a 3-month intervention (TENS unit use) during endometriosis flares with 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.

Study Cohort for TENS

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)

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  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

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  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

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  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

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  PMID: 25655828 RESULT

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  PMID: 31779988 RESULT

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  PMID: 27502806 RESULT

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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

Results Point of Contact

• Title: Kristin Riley, M.D.
• Organization: The Pennsylvania State University

kriley1@pennstatehealth.psu.edu

717-531-0003

Study Officials

• Kristin W Riley, MD

  Penn State Health Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• 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: 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 during endometriosis flares) followed by a 3-month "treatment" period (TENS unit use during 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: August 4, 2026
• Results First Posted: August 4, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)