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

Completed · Not applicable · Has a placebo group

Conditions studied: Non-Specific Chronic Lower Back Pain

In brief

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.

Key facts

Study ID: NCT05972889
Run by: Zynex Medical, Inc.
People needed: 334
Starts: 2023-11-02
Expected to finish: 2025-10-21
Last updated by the study team: 2025-10-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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
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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.