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

Sponsor

Zynex Medical, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972889

Collaborator

(none)

336

Enrollment

Location

Arms

11.2

Anticipated Duration (Months)

30.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Specific Chronic Lower Back Pain	Device: NexWave Device: Sham	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 25, 2023

Anticipated Primary Completion Date :

Jun 28, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device TENS	Device: NexWave Device subjects receive designated treatment mode twice daily for up to 8 weeks.
Experimental: Device IFC	Device: NexWave Device subjects receive designated treatment mode twice daily for up to 8 weeks.
Sham Comparator: Sham TENS	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).
Sham Comparator: Sham IFC	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).
No Intervention: 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).

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale Pain Rating - NexWave vs. Sham [Four weeks]
VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects.
Visual Analogue Scale Pain Rating - NexWave vs. Control [Four weeks]
VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.

Secondary Outcome Measures

Oswestry Disability Index (ODI) - NexWave vs. Sham [Four weeks]
ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.
Oswestry Disability Index (OD) - NexWave vs. Control [Four weeks]
ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Center for Clinical Research, LLC	Winston-Salem	North Carolina	United States	27103

Sponsors and Collaborators

Zynex Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zynex Medical, Inc.

ClinicalTrials.gov Identifier:

NCT05972889

Other Study ID Numbers:

ZMI-2023-NexWave-vs-Sham

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Zynex Medical, Inc.

TENS

IFC

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Aug 2, 2023