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

NCT05972889 | Completed FDA Device

• 1 other identifier: ZMI-2023-NexWave-vs-Sham
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

TENS; IFC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Oswestry Disability Index (ODI) - NexWave vs. Sham

  Four weeks

• Oswestry Disability Index (OD) - NexWave vs. Control

  Four weeks

Study Arms (5)

Device TENS

EXPERIMENTAL

Device: NexWave

Device IFC

EXPERIMENTAL

Device: NexWave

Sham TENS

SHAM COMPARATOR

Device: Sham

Sham IFC

SHAM COMPARATOR

Device: Sham

Control

NO INTERVENTION

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).

Interventions

NexWave DEVICE

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

Device IFC; Device TENS

Sham DEVICE

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).

Sham IFC; Sham TENS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-70, or older if specified by law
• Non-specific chronic lower back pain defined as:
• Having lasted ≥3 months in duration
• Current Visual Analogue Scale (VAS) pain rating ≥50 out of 100 (or an equivalent of 5 out of 10 on a 10-point scale)
• No radiating pain below the knee
• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zynex Medical, Inc.: lead

Study Sites (8)

DBPS Research

Greenwood Village, Colorado, 80111, United States

Location

McGreevy NeuroHealth

Saint Augustine, Florida, 32095, United States

Location

Peachtree Orthopedics

Atlanta, Georgia, 30327, United States

Location

Horizon Clinical Research

Jasper, Georgia, 30143, United States

Location

Applied Pain Institute, LLC

Bloomington, Illinois, 61701, United States

Location

One Oak Medical

Congers, New York, 10920, United States

Location

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Summit Brain, Spine and Orthopedics

Lehi, Utah, 84043, United States

Location

Study Officials

• Christopher Gilmore, MD

  The Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: November 2, 2023
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)