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

Avazzia

Status

Unknown

Conditions

Carpal Tunnel Syndrome

Treatments

Device: Sham PRO-SPORT Ultra® Device

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

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT04271319

RA-190930-CTS-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts 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.