Status:
UNKNOWN
Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Pelvic Pain in Adults
Lead Sponsor:
Albany Medical College
Conditions:
Chronic Pelvic Pain
Eligibility:
All Genders
18-90 years
Phase:
NA
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 de...
Detailed Description
Adults ages 18-90 years old who have first been given the standard of care therapy according to the AUA/EUA guidelines depending on their specific pain modality, first line treatments based on suspect...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 18 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06019091
Start Date
July 20 2022
End Date
April 18 2024
Last Update
September 1 2023
Active Locations (1)
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1
Albany Medical Center
Albany, New York, United States, 12208