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

NCT04271319 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-07-27

No results posted yet for this study

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).

Conditions

  • Carpal Tunnel Syndrome

Interventions

DEVICE

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

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

DEVICE

Sham PRO-SPORT Ultra® Device

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.

Sponsors & Collaborators

  • Joseph Surace, D.C.

    collaborator UNKNOWN

  • Avazzia, Inc

    lead INDUSTRY

Principal Investigators

  • Joseph Surace, D.C. · Activated Family Chiropractic & Wellness

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271319 on ClinicalTrials.gov