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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Pelvic Pain
Intervention / Treatment

-

Contacts and Locations

Albany

Albany Medical Center, Albany, New York, United States, 12208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Albany Medical College,

Elise De, MD, PRINCIPAL_INVESTIGATOR, Urologist at Albany Medical Center

Study Record Dates

2024-04-18