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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Non-Specific Chronic Lower Back Pain

Intervention / Treatment
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* Device: NexWave
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device TENS<br> | Device: NexWave<br>* Device subjects receive designated treatment mode twice daily for up to 8 weeks.<br>|
| Experimental: Device IFC<br> | Device: NexWave<br>* Device subjects receive designated treatment mode twice daily for up to 8 weeks.<br>|
| Sham Comparator: Sham TENS<br> | Device: Sham<br>* Sham subjects provided with Sham Device and treatment instructions identical to that of NexWave Device Arm for their designated Sham Arm. Sham subjects participate for 4 weeks with the option to crossover to the NexWave Device Arm for an additional 4 weeks (up to 8 weeks total).<br>|
| Sham Comparator: Sham IFC<br> | Device: Sham<br>* Sham subjects provided with Sham Device and treatment instructions identical to that of NexWave Device Arm for their designated Sham Arm. Sham subjects participate for 4 weeks with the option to crossover to the NexWave Device Arm for an additional 4 weeks (up to 8 weeks total).<br>|
| No Intervention: Control<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale Pain Rating - NexWave vs. Sham | VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects. | Four weeks | 
| Visual Analogue Scale Pain Rating - NexWave vs. Control | VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects. | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) - NexWave vs. Sham | ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects. | Four weeks | 
| Oswestry Disability Index (OD) - NexWave vs. Control | ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects. | Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TENS, IFC