An interventional study of BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device and Sham PRO-SPORT Ultra® Device in Carpal Tunnel Syndrome, sponsored by Avazzia, Inc. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Avazzia, Inc · Not applicable, Interventional, and Treatment
A clinical study at Activated Family Chiropractic \& Wellness, is being proposed to test the efficacy of a novel electrical stimulation platform named the Pro-Sport Ultra® designed by AVAZZIA to relieve pain and improve mobility in patients with Carpal Tunnel Syndrome (CTS).
This study will recruit patients with a prior diagnosis (Dx) of CTS and have had a trial of conservative treatment for a minimum of 4 weeks without successful results due to continuing symptoms that interfere with normal function.
The primary objective of this study is to compare the changes obtained in CTS that have not successfully responded to non-surgical management by incorporating PRO-Sport Ultra® as opposed to an inactive device. This study aims to compare improvement obtained in CTS using the new therapy.
All participants will be randomized into two treatment groups and receive treatment with both active and inactive devices during the study. During the first 2 weeks, one group will receive treatment with the active device and the other group will receive treatment with the inactive device. At the end of week 3 (no treatment week), participants will return to the clinic and will be crossed over for the next 2 weeks of treatment.
The Avazzia PRO-Sport Ultra® and BEST-RSI® devices are non-invasive, hand-held, battery operated microcurrent devices that are FDA-cleared for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Avazzia, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Confirmation of this Dx shall include at least three findings as defined below:
Exclusion Criteria:
Participants will receive treatment with an active electrical stimulation device for 7 in-clinic treatments over 2 weeks.
Device: BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device
Participants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks.
Device: Sham PRO-SPORT Ultra® Device
Participants will receive treatment with an active electrical stimulation device for 7 in-clinic treatments over 2 weeks. Active Avazzia PRO-Sport Ultra® medical device, BEST™ HVPC microcurrent electrical stimulation, FDA cleared for pain relief
Participants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks. Sham PRO-SPORT Ultra® device will be used. The built in electrodes and the accessory port for connecting the lead wire to the electrode pads will be disconnected internal to the device. The device will power on with the same sounds and indications.
Pain Level Assessment
Change in pain associated with CTS during visit #1, 7, 8 ,14, and visit 15 \[Time Frame: baseline to 5 weeks\] Pain will be assessed with VAS (Visual Analog Scale pain score) from 0 to 10 where 10 is the worst pain ever.
Time frame: 5 weeks
Motor Function Examination
Change in the score of motor function examination during visit #1, 7, 8 ,14, and visit 15 \[Time Frame: baseline to 5 weeks\] Change will be assessed using the motor function score from 0 to 5 where 5 is full range of motion.
Time frame: 5 weeks
Nerve Conduction Velocity
Nerve conduction velocity during visit #1, 7, 8 ,14, and visit 15 \[Time Frame: baseline to 5 weeks\] Change in nerve conduction velocity will be assessed from the score obtained from testing done by the Mediracer Carpal Tunnel Syndrome Sensory exam from normal to severe.
Time frame: 5 weeks
Healthy Related Quality of Life Changes
Change in health Related Quality of Life during visit #1, 7, 8 ,14, and visit 15 \[Time Frame: baseline to 5 weeks\] Change will be assessed with QuickDash score from 0 to 100 where 100 is most severe disability.
Time frame: 5 weeks
Sensory ability changes
Change in sensory ability during visit #1 and 15 \[Time Frame: baseline to 5 weeks\] Change will be assessed with Katz Hand Diagram.
Time frame: 5 weeks
Dosage/Frequency of Analgesics changes
Change in frequency and dosage of analgesics during visit #1, 7, 8 ,14, and visit 15 \[Time Frame: baseline to 5 weeks\] Change will be assessed with comparison of frequency and analgesics from visit to visit.
Time frame: 5 weeks
Plan to share: No
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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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