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

NCT06019091 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-09-01

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Elise De, MD · Urologist at Albany Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2024-04-18
Completion
2024-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019091 on ClinicalTrials.gov