Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Pelvic Pain in Adults
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ClinicalTrials.gov Identifier: NCT06019091 |
Recruitment Status :
Recruiting
First Posted : August 31, 2023
Last Update Posted : September 1, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Pelvic Pain | Device: Compass Health TENS 3000, 3 mode Analog Unit | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The participants will be randomized into three groups of 25 participants each for a total of 75 participants. The randomization will occur in blocks so that if the investigators need to terminate the study early there will be an equal number of participants in each group. The size of the blocks will also be kept secret for allocation concealment purposes. The randomization will be stratified by gender so that there is an equal number of participants from each gender in each group, reducing potential for gender as a confounding variable. Group 1 will be the low frequency set at 20 Hz. Group 2 will be the medium frequency set at 50 Hz. Group 3 will be the high frequency set 100 Hz. There is no sham group in this study as it has previously been found that posterior tibial TENS is effective and lasting. As such, all participants will be treated as a matter of routine medical care for pelvic pain. |
Masking: | Single (Participant) |
Masking Description: | There will be single blinding. Study participants/caretakers will not know which frequency has been assigned. |
Primary Purpose: | Treatment |
Official Title: | Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Pelvic Pain in Adults |
Actual Study Start Date : | July 20, 2022 |
Estimated Primary Completion Date : | April 18, 2024 |
Estimated Study Completion Date : | April 18, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Group 1, low frequency group, 20 Hz.
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) 20 Hz
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Device: Compass Health TENS 3000, 3 mode Analog Unit
The TENS unit Compass Health TENS 3000, 3 mode Analog Unit will be configured based on randomization to 20 Hz, 50 Hz, or 100 Hz. Pulse width 200 microseconds, Normal (N) Mode. It will be used on the posterior tibial nerve via a patch that is supplied each day for 30 minutes of the day. These 30 minutes of intervention will occur at the participants most painful time of the day for their pain. |
Active Comparator: Group 2, medium frequency, 50 Hz.
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
|
Device: Compass Health TENS 3000, 3 mode Analog Unit
The TENS unit Compass Health TENS 3000, 3 mode Analog Unit will be configured based on randomization to 20 Hz, 50 Hz, or 100 Hz. Pulse width 200 microseconds, Normal (N) Mode. It will be used on the posterior tibial nerve via a patch that is supplied each day for 30 minutes of the day. These 30 minutes of intervention will occur at the participants most painful time of the day for their pain. |
Active Comparator: Group 3, high frequency, 100 Hz.
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
|
Device: Compass Health TENS 3000, 3 mode Analog Unit
The TENS unit Compass Health TENS 3000, 3 mode Analog Unit will be configured based on randomization to 20 Hz, 50 Hz, or 100 Hz. Pulse width 200 microseconds, Normal (N) Mode. It will be used on the posterior tibial nerve via a patch that is supplied each day for 30 minutes of the day. These 30 minutes of intervention will occur at the participants most painful time of the day for their pain. |
- Percent change in VAS and GUPI pain questionnaires from baseline to after two weeks of therapy. [ Time Frame: Three weeks ]
The primary objective of the study is to compare the three TENS treatment groups after two weeks of active treatment, with respect to:
The change in VAS and GUPI pain questionnaires from baseline to after two weeks of therapy.
- VAS questionnaire score comparison across the three TENS treatment groups [ Time Frame: Three Weeks ]
This secondary objective includes comparison of the three treatment groups with respect to the rating of VAS (Visual Analog Scale)scores separately (minimum value 0 least painful, maximum value 10 most painful). Analysis will be carried out to determine if there are time-dependent changes in questionnaire scores across the three TENS treatment groups.
Pairwise comparisons of TENS groups will also be carried out to compare each arm with one another using Tukey's multiple comparison tests.
- Time dependent changes in VAS questionnaire scores across the three TENS treatment groups [ Time Frame: Three Weeks ]
This secondary objective includes comparison of the three treatment groups with respect to the rating of VAS (Visual Analog Scale) scores overtime (by weekly diary entries) (minimum value 0 least pain, maximum value 10 most painful). Analysis will be carried out to determine if there are time-dependent changes in questionnaire scores across the three TENS treatment groups.
Pairwise comparisons of TENS groups will also be carried out to compare each arm with one another using Tukey's multiple comparison tests.
- GUPI questionnaire score comparison across the three TENS treatment groups [ Time Frame: Three Weeks ]
This secondary objective includes comparison of the three treatment groups with respect to the rating of GUPI (genitourinary pain index) scores separately (minimum value 0 delighted, maximum value 6 terrible). Analysis will be carried out to determine if there are time-dependent changes in questionnaire scores across the three TENS treatment groups.
Pairwise comparisons of TENS groups will also be carried out to compare each arm with one another using Tukey's multiple comparison tests.
- Time dependent changes in GUPI questionnaire scores across the three TENS treatment groups [ Time Frame: Three Weeks ]
This secondary objective includes comparison of the three treatment groups with respect to the rating of GUPI (genitourinary pain index) scores over time (minimum value 0 delighted, maximum value 6 terrible). Analysis will be carried out to determine if there are time-dependent changes in questionnaire scores across the three TENS treatment groups.
Pairwise comparisons of TENS groups will also be carried out to compare each arm with one another using Tukey's multiple comparison tests.
- Durability in optional extension phase of study [ Time Frame: Three Months ]The investigators will again collect data at 1,2, and 3-months post-trial, asking how much the TENS has been used, to assess durability. This will be in a form that contains space to put the date and amount of time that the TENS unit was used for.
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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06019091
Contact: Brenda Romeo, CCRC | 5182628579 | AMCUrologyresearch@amc.edu | |
Contact: Bobbie Ellis | 5182628579 | AMCUrologyresearch@amc.edu |
United States, New York | |
Albany Medical Center | Recruiting |
Albany, New York, United States, 12208 | |
Contact: Brenda Romeo, CCRC 518-262-8579 AMCUrologyresearch@amc.edu | |
Contact: Bobbie Ellis 518-262-8579 AMCUrologyresearch@amc.edu | |
Principal Investigator: Elise De, MD |
Principal Investigator: | Elise De, MD | Urologist at Albany Medical Center |
Documents provided by Elise De, Albany Medical College:
Responsible Party: | Elise De, Principal Investigator, Albany Medical College |
ClinicalTrials.gov Identifier: | NCT06019091 |
Other Study ID Numbers: |
6485 |
First Posted: | August 31, 2023 Key Record Dates |
Last Update Posted: | September 1, 2023 |
Last Verified: | August 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Chronic pelvic pain Chronic primary pelvic pain syndrome Posterior tibial nerve stimulation Transcutaneous electrical nerve stimulation Neuromodulation |
Pelvic Pain Pain Neurologic Manifestations |