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

CompletedNot applicableNCT05972889
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

Official 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
Conditions
  • Non-Specific Chronic Lower Back Pain
Interventions
Sponsor
Zynex Medical, Inc.
Start date
2023-11-02
Primary completion
2025-10-21
Sex
All
Age range
from 18 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
8

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05972889