NCT05972889View on ClinicalTrials.gov

Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP

NAActive, not recruitingINTERVENTIONAL
Enrollment

334

Participants

Timeline

Start Date

November 2, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

November 30, 2025

Conditions
Non-Specific Chronic Lower Back Pain
Interventions
DEVICE

NexWave

Device subjects receive designated treatment mode twice daily for up to 8 weeks.

DEVICE

Sham

Sham subjects provided with Sham Device and treatment instructions identical to that of NexWave Device Arm for their designated Sham Arm. Sham subjects participate for 4 weeks with the option to crossover to the NexWave Device Arm for an additional 4 weeks (up to 8 weeks total).

Trial Locations (8)

10920

One Oak Medical, Congers

27103

The Center for Clinical Research, LLC, Winston-Salem

30143

Horizon Clinical Research, Jasper

30327

Peachtree Orthopedics, Atlanta

32095

McGreevy NeuroHealth, Saint Augustine

61701

Applied Pain Institute, LLC, Bloomington

80111

DBPS Research, Greenwood Village

84043

Summit Brain, Spine and Orthopedics, Lehi

All Listed Sponsors
lead

Zynex Medical, Inc.

INDUSTRY

NCT05972889 - Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP | Biotech Hunter | Biotech Hunter