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

NCT04271319 | Unknown FDA Device

• 1 other identifier: RA-190930-CTS-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Carpal Tunnel Syndrome

Keywords

musculoskeletal disorder; median nerve; carpal tunnel; hand numbness; electric stimulation; microcurrent

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Healthy Related Quality of Life Changes

  5 weeks

• Sensory ability changes

  5 weeks

• Dosage/Frequency of Analgesics changes

  5 weeks

Study Arms (2)

BEST™ Pro-Sport Ultra® microcurrent device

EXPERIMENTAL

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

Electrical Stimulation - Sham Comparator

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

Interventions

BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device 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

BEST™ Pro-Sport Ultra® microcurrent device

Sham PRO-SPORT Ultra® Device 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.

Electrical Stimulation - Sham Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avazzia, Inc: lead
• Joseph Surace, D.C.: collaborator

Study Sites (1)

Activated Family Chiropractic and Wellness

Dallas, Texas, 75240, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Musculoskeletal Diseases; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Joseph Surace, D.C.

  Activated Family Chiropractic & Wellness

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (participant, care provider)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: February 17, 2020
• Study Start: September 14, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)