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

Zynex Medical

Status: Enrolling

Conditions: Non-Specific Chronic Lower Back Pain

Treatments: Device: Sham; Device: NexWave

Study type: Interventional

Funder types: Industry

Identifiers

NCT05972889

ZMI-2023-NexWave-vs-Sham

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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336 participants in 5 patient groups

Device TENS

Experimental group

Treatment:

Device: NexWave

Device IFC

Experimental group

Treatment:

Device: NexWave

Sham TENS

Sham Comparator group

Treatment:

Device: Sham

Sham IFC

Sham Comparator group

Treatment:

Device: Sham

Control

No Intervention group

Description:

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).