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

NCT ID: NCT04271319

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2021-08-31

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).

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BEST™ Pro-Sport Ultra® microcurrent device

Participants will receive treatment with an active electrical stimulation device for 7 in-clinic treatments over 2 weeks.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Electrical Stimulation - Sham Comparator

Participants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks.

Group Type: SHAM_COMPARATOR

Sham PRO-SPORT Ultra® Device

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Joseph Surace, D.C.

UNKNOWN

Sponsor Role: collaborator

Avazzia, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Surace, D.C.

Role: PRINCIPAL_INVESTIGATOR

Activated Family Chiropractic & Wellness

Locations

Activated Family Chiropractic and Wellness

Dallas, Texas, United States

Countries

United States

Other Identifiers

RA-190930-CTS-01

Identifier Type: -

Identifier Source: org_study_id