Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP
Non-Specific Chronic Lower Back Pain
About this trial
This is an interventional treatment trial for Non-Specific Chronic Lower Back Pain focused on measuring TENS, IFC
Eligibility Criteria
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
Sites / Locations
- The Center for Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Sham Comparator
Sham Comparator
No Intervention
Device TENS
Device IFC
Sham TENS
Sham IFC
Control
Subjects continue with current standard of care only for 4 weeks with the option to crossover to the NexWave Device group for an additional 4 weeks (up to 8 total weeks).