Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Pelvic Pain in Adults

NCT06019091 | Unknown FDA Device

• 1 other identifier: 6485
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

TENS (transcutaneous electrical nerve stimulation) is accepted as a standard treatment for chronic pelvic pain, but the best settings to recommend, including frequency of stimulation, have not been defined to date. This study aims to find the optimal frequency, also known as cycles per second or Hertz (Hz) for treating chronic pelvic pain using non-invasive skin-level electrical nerve stimulation. The investigators will see how people respond to (20Hz, 50Hz or 100Hz). The study will have a two week control period (one week that looks back retrospectively at the week prior and another week looking prospectively at the patient symptoms) with no TENS unit and the participants normal standard of care treatments. This will be followed by 2 weeks of active TENS treatment for 30 minutes a day at the most painful time of day for the participant. The participant will also be allowed to extend their trial to study for durability for up to 3 additional months after the initial study. Participants will be asked to fill out a VAS (visual analog scale), GUPI (genitourinary pain index) and TENS usage log weekly.

Conditions

Chronic Pelvic Pain

Keywords

Chronic pelvic pain; Chronic primary pelvic pain syndrome; Posterior tibial nerve stimulation; Transcutaneous electrical nerve stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Percent change in VAS and GUPI pain questionnaires from baseline to after two weeks of therapy.

  The primary objective of the study is to compare the three TENS treatment groups after two weeks of active treatment, with respect to: The change in VAS and GUPI pain questionnaires from baseline to after two weeks of therapy.

  Three weeks

Secondary Outcomes (5)

• VAS questionnaire score comparison across the three TENS treatment groups

  Three Weeks

• Time dependent changes in VAS questionnaire scores across the three TENS treatment groups

  Three Weeks

• GUPI questionnaire score comparison across the three TENS treatment groups

  Three Weeks

• Time dependent changes in GUPI questionnaire scores across the three TENS treatment groups

  Three Weeks

• Durability in optional extension phase of study

  Three Months

Study Arms (3)

Group 1, low frequency group, 20 Hz.

ACTIVE COMPARATOR

Compass Health TENS 3000, 3 mode Analog Unit. Normal Mode (N), pulse width of 200 microseconds and an intensity to be determined in the office based upon when the participant feels sensitive to the TENS unit. Frequency (pulse rate) 20 Hz

Device: Compass Health TENS 3000, 3 mode Analog Unit

Group 2, medium frequency, 50 Hz.

ACTIVE COMPARATOR

Compass Health TENS 3000, 3 mode Analog Unit. Normal Mode (N), pulse width of 200 microseconds and an intensity to be determined in the office based upon when the participant feels sensitive to the TENS unit. Frequency (pulse rate) 50 Hz

Device: Compass Health TENS 3000, 3 mode Analog Unit

Group 3, high frequency, 100 Hz.

ACTIVE COMPARATOR

Compass Health TENS 3000, 3 mode Analog Unit. Normal Mode (N), a pulse width of 200 microseconds and an intensity to be determined in the office based upon when the participant feels sensitive to the TENS unit. Frequency (pulse rate) 100 Hz

Device: Compass Health TENS 3000, 3 mode Analog Unit

Interventions

Compass Health TENS 3000, 3 mode Analog Unit DEVICE

The TENS unit Compass Health TENS 3000, 3 mode Analog Unit will be configured based on randomization to 20 Hz, 50 Hz, or 100 Hz. Pulse width 200 microseconds, Normal (N) Mode. It will be used on the posterior tibial nerve via a patch that is supplied each day for 30 minutes of the day. These 30 minutes of intervention will occur at the participants most painful time of the day for their pain.

Group 1, low frequency group, 20 Hz.; Group 2, medium frequency, 50 Hz.; Group 3, high frequency, 100 Hz.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting with chronic pelvic pain (chronic/persistent pain that has been continuous or recurrent for at least three months (in accordance with EAU Guidelines).
• Unsuccessful initial interventions based on initial assessments
• Ability to provide informed consent and complete study requirements
• Ability to complete a comprehensive history (including with an interpreter)

You may not qualify if:

• Participants who have previously tried a new pharmacologic treatment for pelvic pain, neuromodulation or other alternative therapy for urologic disorders within the past 30 days
• Inability to work a TENS unit
• Any contraindications to usage of a TENS unit (pacemaker or other implantable device, lymphedema, pregnancy, malignancy, bleeding or clotting disorders, unhealthy tissue, seizure disorders, impaired cognition)
• Any history of electrophysiologic heart disease or complications
• Source of pain being an obvious anatomic issue requiring alternative treatment - for example urethral diverticulum, distal ureteric stone.
• Participant who is pregnant
• Participant with adhesive allergy either reported by the participant or upon chart review

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Related Publications (13)

• Sharma N, Rekha K, Srinivasan JK. Efficacy of transcutaneous electrical nerve stimulation in the treatment of chronic pelvic pain. J Midlife Health. 2017 Jan-Mar;8(1):36-39. doi: 10.4103/jmh.JMH_60_16.

  PMID: 28458478 BACKGROUND

• Erol B, Danacioglu YO, Peters KM. Current advances in neuromodulation techniques in urology practices: A review of literature. Turk J Urol. 2021 Sep;47(5):375-385. doi: 10.5152/tud.2021.21152.

  PMID: 35118977 BACKGROUND

• Cottrell AM, Schneider MP, Goonewardene S, Yuan Y, Baranowski AP, Engeler DS, Borovicka J, Dinis-Oliveira P, Elneil S, Hughes J, Messelink BJ, de C Williams AC. Benefits and Harms of Electrical Neuromodulation for Chronic Pelvic Pain: A Systematic Review. Eur Urol Focus. 2020 May 15;6(3):559-571. doi: 10.1016/j.euf.2019.09.011. Epub 2019 Oct 19.

  PMID: 31636030 BACKGROUND

• Fall M, Baranowski AP, Elneil S, Engeler D, Hughes J, Messelink EJ, Oberpenning F, de C Williams AC; European Association of Urology. EAU guidelines on chronic pelvic pain. Eur Urol. 2010 Jan;57(1):35-48. doi: 10.1016/j.eururo.2009.08.020. Epub 2009 Aug 31.

  PMID: 19733958 BACKGROUND

• Maher CF, Carey MP, Dwyer PL, Schluter PL. Percutaneous sacral nerve root neuromodulation for intractable interstitial cystitis. J Urol. 2001 Mar;165(3):884-6.

  PMID: 11176493 BACKGROUND

• Tutolo M, Ammirati E, Heesakkers J, Kessler TM, Peters KM, Rashid T, Sievert KD, Spinelli M, Novara G, Van der Aa F, De Ridder D. Efficacy and Safety of Sacral and Percutaneous Tibial Neuromodulation in Non-neurogenic Lower Urinary Tract Dysfunction and Chronic Pelvic Pain: A Systematic Review of the Literature. Eur Urol. 2018 Mar;73(3):406-418. doi: 10.1016/j.eururo.2017.11.002. Epub 2018 Jan 12.

  PMID: 29336927 BACKGROUND

• Tugay N, Akbayrak T, Demirturk F, Karakaya IC, Kocaacar O, Tugay U, Karakaya MG, Demirturk F. Effectiveness of transcutaneous electrical nerve stimulation and interferential current in primary dysmenorrhea. Pain Med. 2007 May-Jun;8(4):295-300. doi: 10.1111/j.1526-4637.2007.00308.x.

  PMID: 17610451 BACKGROUND

• Mira TA, Giraldo PC, Yela DA, Benetti-Pinto CL. Effectiveness of complementary pain treatment for women with deep endometriosis through Transcutaneous Electrical Nerve Stimulation (TENS): randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:1-6. doi: 10.1016/j.ejogrb.2015.07.009. Epub 2015 Aug 6.

  PMID: 26319650 BACKGROUND

• Johnson MI, Paley CA, Jones G, Mulvey MR, Wittkopf PG. Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). BMJ Open. 2022 Feb 10;12(2):e051073. doi: 10.1136/bmjopen-2021-051073.

  PMID: 35144946 BACKGROUND

• Chen YJ, Zhou GY, Jin JH. [Transcutaneous electrical acupoint stimulation combined with auricular acupoint sticking for treatment of primary nocturnal enuresis]. Zhongguo Zhen Jiu. 2010 May;30(5):371-4. Chinese.

  PMID: 20518171 BACKGROUND

• Tai C, Shen B, Chen M, Wang J, Liu H, Roppolo JR, de Groat WC. Suppression of bladder overactivity by activation of somatic afferent nerves in the foot. BJU Int. 2011 Jan;107(2):303-9. doi: 10.1111/j.1464-410X.2010.09358.x.

  PMID: 20394612 BACKGROUND

• Vance CG, Rakel BA, Blodgett NP, DeSantana JM, Amendola A, Zimmerman MB, Walsh DM, Sluka KA. Effects of transcutaneous electrical nerve stimulation on pain, pain sensitivity, and function in people with knee osteoarthritis: a randomized controlled trial. Phys Ther. 2012 Jul;92(7):898-910. doi: 10.2522/ptj.20110183. Epub 2012 Mar 30.

  PMID: 22466027 BACKGROUND

• Barroso U Jr, Viterbo W, Bittencourt J, Farias T, Lordelo P. Posterior tibial nerve stimulation vs parasacral transcutaneous neuromodulation for overactive bladder in children. J Urol. 2013 Aug;190(2):673-7. doi: 10.1016/j.juro.2013.02.034. Epub 2013 Feb 16.

  PMID: 23422257 BACKGROUND

Study Officials

• Elise De, MD

  Urologist at Albany Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Romeo, CCRC

CONTACT

5182628579; AMCUrologyresearch@amc.edu

Bobbie Ellis

CONTACT

5182628579; AMCUrologyresearch@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: There will be single blinding. Study participants/caretakers will not know which frequency has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The participants will be randomized into three groups of 25 participants each for a total of 75 participants. The randomization will occur in blocks so that if the investigators need to terminate the study early there will be an equal number of participants in each group. The size of the blocks will also be kept secret for allocation concealment purposes. The randomization will be stratified by gender so that there is an equal number of participants from each gender in each group, reducing potential for gender as a confounding variable. Group 1 will be the low frequency set at 20 Hz. Group 2 will be the medium frequency set at 50 Hz. Group 3 will be the high frequency set 100 Hz. There is no sham group in this study as it has previously been found that posterior tibial TENS is effective and lasting. As such, all participants will be treated as a matter of routine medical care for pelvic pain.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: August 31, 2023
• Study Start: July 20, 2022
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

US (1)