Clinical trial NCT04271319: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: musculoskeletal disorder
median nerve
carpal tunnel
hand numbness
electric stimulation
microcurrent
Lead sponsor: Avazzia, Inc
Sponsor class: INDUSTRY
Collaborators: name: Joseph Surace, D.C.
First posted: 2020-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Level Assessment
timeFrame: 5 weeks
measure: Motor Function Examination
timeFrame: 5 weeks
measure: Nerve Conduction Velocity
timeFrame: 5 weeks
Secondary outcomes:
measure: Healthy Related Quality of Life Changes
timeFrame: 5 weeks
measure: Sensory ability changes
timeFrame: 5 weeks
measure: Dosage/Frequency of Analgesics changes
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Activated Family Chiropractic and Wellness
state: Texas
Study officials:
affiliation: Activated Family Chiropractic & Wellness
name: Joseph Surace, D.C.
role: PRINCIPAL_INVESTIGATOR
References: