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

NCT ID: NCT05972889

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2025-10-21

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 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.

Conditions

Non-Specific Chronic Lower Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Device TENS

Group Type: EXPERIMENTAL

NexWave

Intervention Type: DEVICE

Device subjects receive designated treatment mode twice daily for up to 8 weeks.

Device IFC

Group Type: EXPERIMENTAL

NexWave

Intervention Type: DEVICE

Device subjects receive designated treatment mode twice daily for up to 8 weeks.

Sham TENS

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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).

Sham IFC

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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).

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NexWave

Device subjects receive designated treatment mode twice daily for up to 8 weeks.

Intervention Type: DEVICE

Sham

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zynex Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Gilmore, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Clinical Research

Locations

DBPS Research

Greenwood Village, Colorado, United States

McGreevy NeuroHealth

Saint Augustine, Florida, United States

Peachtree Orthopedics

Atlanta, Georgia, United States

Horizon Clinical Research

Jasper, Georgia, United States

Applied Pain Institute, LLC

Bloomington, Illinois, United States

One Oak Medical

Congers, New York, United States

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, United States

Summit Brain, Spine and Orthopedics

Lehi, Utah, United States

Countries

United States

Other Identifiers

ZMI-2023-NexWave-vs-Sham

Identifier Type: -

Identifier Source: org_study_id