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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Carpal Tunnel Syndrome

In brief

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).

Key facts

Study ID

NCT04271319

Run by

Avazzia, Inc

People needed

120

Starts

2020-09-14

Expected to finish

2021-08-31

Last updated by the study team

2021-07-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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
• 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

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.