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

Primary Purpose

Carpal Tunnel Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Sham PRO-SPORT Ultra® Device

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring musculoskeletal disorder, median nerve, carpal tunnel, hand numbness, electric stimulation, microcurrent

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Activated Family Chiropractic and Wellness

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

BEST™ Pro-Sport Ultra® microcurrent device

Electrical Stimulation - Sham Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04271319

First Posted

January 22, 2020

Last Updated

July 23, 2021

Sponsor

Avazzia, Inc

Collaborators

Joseph Surace, D.C.

1. Study Identification

Unique Protocol Identification Number

NCT04271319

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 14, 2020 (Actual)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avazzia, Inc

Collaborators

Joseph Surace, D.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

ParticipantInvestigator

Masking Description

Double (participant, care provider)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BEST™ Pro-Sport Ultra® microcurrent device

Arm Type

Experimental

Arm Description

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

Arm Title

Electrical Stimulation - Sham Comparator

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Sham PRO-SPORT Ultra® Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain Level Assessment

Description

Time Frame

5 weeks

Title

Motor Function Examination

Description

Time Frame

5 weeks

Title

Nerve Conduction Velocity

Description

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

Healthy Related Quality of Life Changes

Description

Time Frame

5 weeks

Title

Sensory ability changes

Description

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

Title

Dosage/Frequency of Analgesics changes

Description

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Surace, D.C.

Organizational Affiliation

Activated Family Chiropractic & Wellness

Official's Role

Principal Investigator

Facility Information:

Facility Name

Activated Family Chiropractic and Wellness

City

Dallas

State/Province

Texas

ZIP/Postal Code

75240

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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