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

NCT05972889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2025-10-28

No results posted yet for this study

Summary

This is a prospective, sham-controlled, randomized, single-blinded, multi-center study comparing two different modes of the NexWave device, transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC), with an identical non-functioning NexWave sham device or self-defined standard of care for improvement of pain intensity of non-specific CLBP.

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).

Sponsors & Collaborators

  • Zynex Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Gilmore, MD · The Center for Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2025-10-21
Completion
2025-10-21
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05972889 on ClinicalTrials.gov