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

Randomized Blinded Evaluation of the Effects of Transcutaneous Electrical Nerve Stimulation and Interferential Current Compared to a Sham Device and Standard of Care in Patients With Non-Specific Chronic Lower Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Non-Specific Chronic Lower Back Pain
• Intervention / Treatment: Device: NexWave; Device: Sham

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • DBPS Research
  • Florida
    • Saint Augustine, Florida, United States, 32095
      • McGreevy NeuroHealth
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Peachtree Orthopedics
    • Jasper, Georgia, United States, 30143
      • Horizon Clinical Research
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Applied Pain Institute, LLC
  • New York
    • Congers, New York, United States, 10920
      • One Oak Medical
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research, LLC
  • Utah
    • Lehi, Utah, United States, 84043
      • Summit Brain, Spine and Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ages 18-70, or older if specified by law

• Non-specific chronic lower back pain defined as:

  1. Having lasted ≥3 months in duration
  2. Current Visual Analogue Scale (VAS) pain rating ≥50 out of 100 (or an equivalent of 5 out of 10 on a 10-point scale)
  3. No radiating pain below the knee
  4. ≥75% back or buttock pain rather than lower extremity pain
• Subjects who are willing and capable of providing informed consent
• Subjects who are willing and capable of participating in all testing and questionnaire requirements associated with the clinical study

Exclusion Criteria:

• Any prior home use of the NexWave or any TENS/IFC device
• Any history of lumbar spine surgery or spinal fractures
• Subjects with a history of rheumatic disease
• Subjects with spine disorders, deformities, or severe spinal conditions such as scoliosis and kyphosis, Pott's disease, disc protrusion, or others that can be attributed to specific causes of back pain
• Subjects currently prescribed and adherent to opioid therapy
• Current implanted cardiac pacemakers, defibrillators, cardiac pumps, spinal stimulators, or other implanted electronic devices
• Active psychiatric or uncontrolled mood disorders including subjects on antipsychotic medication, diagnosis of bipolar disorder or schizophrenia, or uncontrolled anxiety or clinical depression
• Subjects with a known history of allergic reactions to medical adhesives or any condition that could affect placement of the electrodes
• Women of childbearing potential who are pregnant or who are planning to become pregnant during the anticipated study period
• Subjects with health conditions that in the Investigator's medical opinion would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation
• Subjects who are currently enrolled in another investigational study that would directly interfere with the current study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham TENS	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).
Experimental: Device TENS	Device: NexWave; Device subjects receive designated treatment mode twice daily for up to 8 weeks.
Experimental: Device IFC	Device: NexWave; Device subjects receive designated treatment mode twice daily for up to 8 weeks.
Sham Comparator: Sham IFC	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).
No Intervention: Control; Subjects continue with current standard of care only for 4 weeks with the option to crossover to the NexWave Device group for an additional 4 weeks (up to 8 total weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale Pain Rating - NexWave vs. Sham	VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects.	Four weeks
Visual Analogue Scale Pain Rating - NexWave vs. Control	VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.	Four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI) - NexWave vs. Sham	ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.	Four weeks
Oswestry Disability Index (OD) - NexWave vs. Control	ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.	Four weeks

Collaborators and Investigators

• Sponsor: Zynex Medical, Inc.
• Investigators: Principal Investigator: Christopher Gilmore, MD, The Center for Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Actual): October 21, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 26, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: TENS; IFC
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Pharmaceutical Preparations; Therapeutics; Placebos
• Other Study ID Numbers: ZMI-2023-NexWave-vs-Sham

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No