RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-20
Study Completion:2024-04-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06019091

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Unsuccessful initial interventions based on initial assessments
  3. 3. Ability to provide informed consent and complete study requirements
  4. 4. Ability to complete a comprehensive history (including with an interpreter)
  1. 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. 2. Inability to work a TENS unit
  3. 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. 4. Any history of electrophysiologic heart disease or complications
  5. 5. Source of pain being an obvious anatomic issue requiring alternative treatment - for example urethral diverticulum, distal ureteric stone.
  6. 6. Participant who is pregnant
  7. 7. Participant with adhesive allergy either reported by the participant or upon chart review

Contacts and Locations

Study Contact

Brenda Romeo, CCRC
CONTACT
5182628579
AMCUrologyresearch@amc.edu
Bobbie Ellis
CONTACT
5182628579
AMCUrologyresearch@amc.edu

Principal Investigator

Elise De, MD
PRINCIPAL_INVESTIGATOR
Urologist at Albany Medical Center

Study Locations (Sites)

Albany Medical Center
Albany, New York, 12208
United States

Collaborators and Investigators

Sponsor: Albany Medical College

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-20
Study Completion Date2024-04-18

Study Record Updates

Study Start Date2022-07-20
Study Completion Date2024-04-18

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Pelvic Pain