Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04271319
Status:
UNKNOWN
Last Update Posted:
2021-07-27
First Post:
2020-01-22
Brief Title:
Avazzia HVPC Bio-Electrical Stimulation Technology BEST Microcurrent CTS RCT
Sponsor:
Avazzia Inc
Organization:
Avazzia Inc
Study Overview
Official Title:
Efficacy of a High Voltage Pulsed Current in the Non-Invasive Treatment of Carpal Tunnel Syndrome
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None