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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
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.
Activated Family Chiropractic and Wellness
Dallas, Texas, United States
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 5 weeks