Skip to main content
OpenTrials
Completed

NCT Number: NCT05972889

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-specific Chronic Lower Back Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DBPS Research, Greenwood Village, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

NexWave

Device

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

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).

Primary outcomes

  1. Visual Analogue Scale Pain Rating - NexWave vs. Sham

    Time frame: Four weeks

    VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects.

  2. Visual Analogue Scale Pain Rating - NexWave vs. Control

    Time frame: Four weeks

    VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.

Secondary outcomes

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

    Time frame: Four weeks

    ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.

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

    Time frame: Four weeks

    ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.

Sponsors and collaborators

Lead sponsor

Zynex Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2023
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.