Finding the best frequency for TENS to treat pelvic pain
Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Pelvic Pain in Adults
This study is testing which frequency of TENS treatment works best to relieve chronic pelvic pain in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Albany Medical College Academic / other |
| Locations | 1 site (Albany, New York) |
| Trial ID | NCT06019091 on ClinicalTrials.gov |
What this trial studies
This study investigates the optimal frequency of transcutaneous electrical nerve stimulation (TENS) for adults suffering from chronic pelvic pain. Participants will undergo a two-week control period without TENS, followed by two weeks of active TENS treatment at varying frequencies (20Hz, 50Hz, or 100Hz) for 30 minutes daily. The study aims to determine which frequency provides the most effective pain relief. Participants may also extend their involvement for up to three additional months to assess the durability of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with chronic pelvic pain who have not found relief from standard treatments.
Not a fit: Patients with contraindications to TENS therapy or those whose pain is due to an obvious anatomical issue may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective non-invasive treatment option for patients with chronic pelvic pain.
How similar studies have performed: While TENS is a standard treatment for chronic pain, this specific investigation into optimal frequency is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Albany, New York
- Albany Medical Center — Albany, New York, United States (Recruiting)
Study contacts
- Principal investigator: Elise De, MD — Urologist at Albany Medical Center
- Study coordinator: Brenda Romeo, CCRC
- Email: AMCUrologyresearch@amc.edu
- Phone: 5182628579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.