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 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972889
• Other study ID #: ZMI-2023-NexWave-vs-Sham
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Zynex Medical, Inc.
• Contact: Kristin Andrud, PhD
• Phone: (800) 495-6670
• Email: kandrud[@]zynex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: August 30, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-Specific Chronic Lower Back Pain

Intervention

Device:
• NexWave
Device subjects receive designated treatment mode twice daily for up to 8 weeks.
• 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).

Locations

Country	Name	City	State
United States	Applied Pain Institute, LLC	Bloomington	Illinois
United States	CAO Research Foundation	Catonsville	Maryland
United States	One Oak Medical	Congers	New York
United States	DBPS Research	Greenwood Village	Colorado
United States	Horizon Clinical Research	Jasper	Georgia
United States	McGreevy NeuroHealth	Saint Augustine	Florida
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Zynex Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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