Status:
UNKNOWN
Avazzia HVPC Bio-Electrical Stimulation Technology (BEST™) Microcurrent CTS RCT
Lead Sponsor:
Avazzia, Inc
Collaborating Sponsors:
Joseph Surace, D.C.
Conditions:
Carpal Tunnel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
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 relie...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04271319
Start Date
September 14 2020
End Date
August 31 2021
Last Update
July 27 2021
Active Locations (1)
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1
Activated Family Chiropractic and Wellness
Dallas, Texas, United States, 75240