Avazzia HVPC Bio-Electrical Stimulation Technology (BEST™) Microcurrent CTS RCT

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Efficacy of a High Voltage Pulsed Current in the Non-Invasive Treatment of Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device
* Device: Sham PRO-SPORT Ultra® Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have 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. Confirmation of this Dx shall include at least three findings as defined below: Muscle atrophy, severe weakness of thenar muscles 2-point discrimination test >6mm Flick sign (shaking hand) Phalen's sign Tinel's sign Reverse Phalen's sign Abnormal Katz hand diagram scores Positive NCV testing Age >18 - <70 years old Males/Females of all ethnicities Post-surgical failures >6 months post op Ability to understand the informed consent document before signing it Exclusion Criteria: Systemic disease that would affect treatment outcome such as inflammatory joint diseases (i.e., rheumatoid arthritis, systemic lupus); malignancies undergoing treatment or any malignancies (in remission or not) with involvement of the musculoskeletal system. Co-morbidities, thoracic outlet nerve impingement, neuropathy, etc. should be identified and, if significant, the candidate should be excluded from the study. Cubital tunnel syndrome, anterior and posterior interosseous nerve syndrome, lateral and medial epicondylitis, handlebar palsy, De Quervain's disease, trigger finger, and Intersection syndrome should be differentiated from CTS and not included in this study. Uncontrolled mood disorders, such as depression, anxiety. Drug or substance abuse within past 90 days. Any hand pathology requiring surgical intervention. Active litigation, workers compensation Any participant with an electrically implanted device such as a pacemaker, neural stimulator, etc. Participant is currently pregnant, nursing, or may become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Device: Avazzia Pro-Sport Ultra® device High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEST™ Pro-Sport Ultra® microcurrent device<br>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<br>* 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<br>|
| Sham Comparator: Electrical Stimulation - Sham Comparator<br>Participants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks. | Device: Sham PRO-SPORT Ultra® Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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musculoskeletal disorder, median nerve, carpal tunnel, hand numbness, electric stimulation, microcurrent