Recruiting

TENS

Sponsor:

Albany Medical College

Code:

NCT06019091

Conditions

Chronic Pelvic Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Compass Health TENS 3000, 3 mode Analog Unit

Study Details

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

Study ID

NCT06019091

Start date

Jul 20, 2022

Status verified date

Aug, 2023

Completion date

Apr 18, 2024

Anticipated

Primary completion date

Apr 18, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. Inability to work a TENS unit
3. 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)
4. Any history of electrophysiologic heart disease or complications
5. Source of pain being an obvious anatomic issue requiring alternative treatment - for example urethral diverticulum, distal ureteric stone.
6. Participant who is pregnant
7. Participant with adhesive allergy either reported by the participant or upon chart review

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1, low frequency group, 20 Hz.

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

active comparator: Group 2, medium frequency, 50 Hz.

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

active comparator: Group 3, high frequency, 100 Hz.

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

Interventions

Compass Health TENS 3000, 3 mode Analog Unit

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.

Primary outcome measure

  • Percent change in VAS and GUPI pain questionnaires from baseline to after two weeks of therapy. [ Time Frame: Three weeks ]

Central Contacts and Locations

Central contacts

Brenda Romeo, CCRC

5182628579AMCUrologyresearch@amc.edu

Bobbie Ellis

5182628579AMCUrologyresearch@amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Brenda Romeo, CCRC

518-262-8579AMCUrologyresearch@amc.edu

Bobbie Ellis

518-262-8579AMCUrologyresearch@amc.edu

Principal Investigator:

Elise De, MD

More Information

Sponsor

Albany Medical College

Last update posted

Sep 1, 2023

Last verified

Aug, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2023-09-01.