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

Not Applicable

Recruiting

• Conditions: Non-Specific Chronic Lower Back Pain
• Interventions: Device: Sham; Device: NexWave

• Registration Number: NCT05972889
• Lead Sponsor: Zynex Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-02
• Study Start: 2023-11-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 336

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham IFC	Sham	-
Sham TENS	Sham	-
Device IFC	NexWave	-
Device TENS	NexWave	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

DBPS Research; 🇺🇸 Greenwood Village, Colorado, United States

McGreevy NeuroHealth; 🇺🇸 Saint Augustine, Florida, United States

Peachtree Orthopedics; 🇺🇸 Atlanta, Georgia, United States

Horizon Clinical Research; 🇺🇸 Jasper, Georgia, United States

Applied Pain Institute, LLC; 🇺🇸 Bloomington, Illinois, United States

CAO Research Foundation; 🇺🇸 Catonsville, Maryland, United States

One Oak Medical; 🇺🇸 Congers, New York, United States

The Center for Clinical Research, LLC; 🇺🇸 Winston-Salem, North Carolina, United States

Summit Brain, Spine and Orthopedics; 🇺🇸 Lehi, Utah, United States