Status:
COMPLETED
Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP
Lead Sponsor:
Zynex Medical, Inc.
Conditions:
Non-Specific Chronic Lower Back Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
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 inter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2025
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT05972889
Start Date
November 2 2023
End Date
October 21 2025
Last Update
October 28 2025
Active Locations (8)
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1
DBPS Research
Greenwood Village, Colorado, United States, 80111
2
McGreevy NeuroHealth
Saint Augustine, Florida, United States, 32095
3
Peachtree Orthopedics
Atlanta, Georgia, United States, 30327
4
Horizon Clinical Research
Jasper, Georgia, United States, 30143