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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device; Device: Sham PRO-SPORT Ultra® Device

Detailed Description

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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75240
      • Activated Family Chiropractic and Wellness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BEST™ Pro-Sport Ultra® microcurrent device; 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 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
SHAM_COMPARATOR: Electrical Stimulation - Sham Comparator; 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 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Avazzia, Inc
• Collaborators: Joseph Surace, D.C.
• Investigators: Principal Investigator: Joseph Surace, D.C., Activated Family Chiropractic & Wellness

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2020
• Primary Completion (ANTICIPATED): August 31, 2021
• Study Completion (ANTICIPATED): August 31, 2021

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: median nerve; microcurrent; electric stimulation; carpal tunnel; hand numbness; musculoskeletal disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: RA-190930-CTS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes