Clinical trial NCT05348005: Use of TENS Unit in the Management of Endometriosis Pain
Official title: A Cross-Over Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Pelvic Pain
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The investigators propose to conduct a 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).

Potential subjects will be pre-screened in the Penn State Minimally Invasive GYN (MIGS) Surgery Clinic for pathologically diagnosed endometriosis and from the Penn State MIGS endometriosis database. Potential subjects will then be called to evaluate the remainder of the inclusion and exclusion criteria. If fulfilled, potential subjects will follow up at the enrollment visit (Visit 1) where consent is reviewed and signed. The baseline QOL and FSFI REDCap surveys will be completed at this visit. Subjects will be set up to receive automated links to complete diary entries and surveys directly in REDCap.

Prior to initiating TENS unit use for endometriosis flare-related pain, subjects will record daily entries into RedCap during episodes of endometriosis flares for 3 months. Each entry will record their VAS pain score as well as medication intake and bleeding profile.

Subjects will then be mailed the TENS unit at the 3 months mark into the study. Subjects will then complete entries with TENS use at their discretion for the following 3 months and record TENS unit use duration, frequency, and side effects in addition to the documentation of pain, medication and bleeding. At the end of the study, subjects will complete a QOL and FSFI survey.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. TENS device exclusion:

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

Primary outcomes:
measure: Change in Average Daily VAS Pain Score
timeFrame: Baseline Period (months 1-3) and Treatment Period (months 4-6)
Secondary outcomes:
measure: Change in Quality of Life Score from baseline to end of study using the EHP30 questionnaire
timeFrame: Baseline and 6 months
measure: Change in Female Sexual Function Index Total Score using the FSFI questionnaire
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Health Hershey Medical Center
name: Kristin W Riley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Greco CD. Management of adolescent chronic pelvic pain from endometriosis: a pain center perspective. J Pediatr Adolesc Gynecol. 2003 Jun;16(3 Suppl):S17-9. doi: 10.1016/s1083-3188(03)00064-0.
citation: Sluka KA, Bjordal JM, Marchand S, Rakel BA. What makes transcutaneous electrical nerve stimulation work? Making sense of the mixed results in the clinical literature. Phys Ther. 2013 Oct;93(10):1397-402. doi: 10.2522/ptj.20120281. Epub 2013 May 2.
citation: Harvey MP, Watier A, Dufort Rouleau E, Leonard G. Non-invasive stimulation techniques to relieve abdominal/pelvic pain: Is more always better? World J Gastroenterol. 2017 May 28;23(20):3758-3760. doi: 10.3748/wjg.v23.i20.3758.
citation: Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2.
citation: 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.
citation: 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.
citation: Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.