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Procedure

TENS for Chronic Pelvic Pain

N/A

Recruiting

Led By Elise De, MD

Research Sponsored by Albany Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three months

Awards & highlights

Study Summary

This trial seeks to find the best frequency of electrical nerve stimulation to treat chronic pelvic pain. Participants will be monitored for 2 weeks with no treatment, then 2 weeks of active treatment with a TENS unit for 30 minutes/day. Results will be tracked on a weekly basis.

Who is the study for?

Adults with chronic pelvic pain who can consent and follow the study plan, have not found relief from initial treatments, and haven't tried new drugs or therapies for urologic issues in the last month. People with pacemakers, pregnancy, cancer, bleeding disorders, seizures or those unable to operate a TENS unit cannot join.Check my eligibility

What is being tested?

The trial is testing different frequencies of electrical nerve stimulation (20Hz, 50Hz or 100Hz) using a Compass Health TENS device to treat chronic pelvic pain. Participants will use it daily for two weeks after an initial control period without the device and may extend their participation up to three months.See study design

What are the potential side effects?

While TENS is generally safe when used correctly, potential side effects include skin irritation at the electrode sites, discomfort during use if settings are too high and possible muscle twitching.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three months

This trial's timeline: 3 weeks for screening, Varies for treatment, and three months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change in VAS and GUPI pain questionnaires from baseline to after two weeks of therapy.

Secondary outcome measures

Durability in optional extension phase of study

GUPI questionnaire score comparison across the three TENS treatment groups

Time dependent changes in GUPI questionnaire scores across the three TENS treatment groups

+2 more

Trial Design

3Treatment groups

Active Control

Group I: Group 2, medium frequency, 50 Hz.Active Control1 Intervention

Compass Health TENS 3000, 3 mode Analog Unit. Normal Mode (N), pulse width of 200 microseconds and an intensity to be determined in the office based upon when the participant feels sensitive to the TENS unit. Frequency (pulse rate) 50 Hz

Group II: Group 3, high frequency, 100 Hz.Active Control1 Intervention

Compass Health TENS 3000, 3 mode Analog Unit. Normal Mode (N), a pulse width of 200 microseconds and an intensity to be determined in the office based upon when the participant feels sensitive to the TENS unit. Frequency (pulse rate) 100 Hz

Group III: Group 1, low frequency group, 20 Hz.Active Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor

91 Previous Clinical Trials

11,422 Total Patients Enrolled

Elise De, MDPrincipal InvestigatorUrologist at Albany Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research opportunity permit octogenarians to participate?

"The requirements for this clinical trial dictates that prospective patients must be between 18 to 90 years old. Alternatively, there are two trials geared towards minors and a separate one targeting individuals over 65."

Answered by AI

Who has the capacity to take part in this experiment?

"Eligibility for this trial is contingent upon the presence of chronic pelvic pain and being between 18-90 years old. 75 participants are needed in total."

Answered by AI

Are recruitment efforts underway for this medical experiment?

"Indeed, the clinicaltrial.gov website indicates that this research trial is actively recruiting patients. This investigation was first advertised in July of 2022 and has been updated as recently as August 30th 2023. 75 individuals are needed to be enrolled at a single medical facility."

Answered by AI

How many participants are being recruited for this research effort?

"Affirmative. According to clinicaltrials.gov, this investigation is currently accepting participants; the initial posting was on July 20th 2022 and a recent alteration occurred August 30th of the following year. 75 individuals must be recruited from one medical centre for participation in the study."

Answered by AI

Recent research and studies

Progrès en UrologieJournal

Énurésie nocturne primaire isolée : diagnostic et prise en charge. recommandations par consensus formalisé d’experts

Aubert, D., É. Berard, J.-P. Blanc, G. Lenoir, F. Liard, and H. Lottmann. 2010. “Énurésie nocturne primaire isolée : diagnostic et prise en charge. recommandations par consensus formalisé d’experts”. Progrès en urologie. Elsevier BV. doi:10.1016/j.purol.2009.12.007.

BJU InternationalJournal

Suppression of Bladder Overactivity by Activation of Somatic Afferent Nerves in the Foot

Tai, Changfeng, Bing Shen, Mang Chen, Jicheng Wang, Hailong Liu, James R. Roppolo, and William C. de Groat. 2011. “Suppression of Bladder Overactivity by Activation of Somatic Afferent Nerves in the Foot”. BJU International. Wiley. doi:10.1111/j.1464-410x.2010.09358.x.

Physical TherapyJournal

Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Pain Sensitivity, and Function in People with Knee Osteoarthritis: A Randomized Controlled Trial

Vance, Carol Grace T., Barbara A. Rakel, Nicole P. Blodgett, Josimari Melo DeSantana, Annunziato Amendola, Miriam Bridget Zimmerman, Deirdre M. Walsh, and Kathleen A. Sluka. 2012. “Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Pain Sensitivity, and Function in People with Knee Osteoarthritis: A Randomized Controlled Trial”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20110183.

clinicaltrials.govStudy