Evaluating the effects of TENS and IFC on chronic lower back pain
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
This study is testing whether two types of electrical stimulation treatments can help people with chronic lower back pain feel better compared to a fake treatment and regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zynex Medical, Inc. Industry-sponsored |
| Locations | 9 sites (Greenwood Village, Colorado and 8 other locations) |
| Trial ID | NCT05972889 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, sham-controlled, randomized, single-blinded, multi-center evaluation comparing the effectiveness of two modes of the NexWave device—transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC)—against a non-functioning sham device and standard of care. The study aims to assess improvements in pain intensity for patients suffering from non-specific chronic lower back pain lasting at least three months. Participants will be monitored for pain relief and overall improvement in their condition throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with non-specific chronic lower back pain lasting three months or more and a significant pain rating.
Not a fit: Patients with specific spinal conditions or prior use of TENS/IFC devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for patients suffering from chronic lower back pain.
How similar studies have performed: Previous studies have shown promising results with TENS and IFC for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Greenwood Village, Colorado and 8 other locations
- DBPS Research — Greenwood Village, Colorado, United States (Recruiting)
- McGreevy NeuroHealth — Saint Augustine, Florida, United States (Recruiting)
- Peachtree Orthopedics — Atlanta, Georgia, United States (Recruiting)
- Horizon Clinical Research — Jasper, Georgia, United States (Recruiting)
- Applied Pain Institute, LLC — Bloomington, Illinois, United States (Recruiting)
- CAO Research Foundation — Catonsville, Maryland, United States (Withdrawn)
- One Oak Medical — Congers, New York, United States (Recruiting)
- The Center for Clinical Research, LLC — Winston-Salem, North Carolina, United States (Recruiting)
- Summit Brain, Spine and Orthopedics — Lehi, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Gilmore, MD — The Center for Clinical Research
- Study coordinator: Kristin Andrud, PhD
- Email: kandrud@zynex.com
- Phone: (800) 495-6670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.