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

Primary Purpose

Non-Specific Chronic Lower Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NexWave
Sham
Sponsored by
Zynex Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Specific Chronic Lower Back Pain focused on measuring TENS, IFC

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Center for Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

No Intervention

Arm Label

Device TENS

Device IFC

Sham TENS

Sham IFC

Control

Arm 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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Oswestry Disability Index (ODI) - NexWave vs. Sham
ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.
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.

Full Information

First Posted
July 25, 2023
Last Updated
July 25, 2023
Sponsor
Zynex Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05972889
Brief Title
Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zynex Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Specific Chronic Lower Back Pain
Keywords
TENS, IFC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device TENS
Arm Type
Experimental
Arm Title
Device IFC
Arm Type
Experimental
Arm Title
Sham TENS
Arm Type
Sham Comparator
Arm Title
Sham IFC
Arm Type
Sham Comparator
Arm Title
Control
Arm Type
No Intervention
Arm 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).
Intervention Type
Device
Intervention Name(s)
NexWave
Intervention Description
Device subjects receive designated treatment mode twice daily for up to 8 weeks.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
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).
Primary Outcome Measure Information:
Title
Visual Analogue Scale Pain Rating - NexWave vs. Sham
Description
VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects.
Time Frame
Four weeks
Title
Visual Analogue Scale Pain Rating - NexWave vs. Control
Description
VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI) - NexWave vs. Sham
Description
ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.
Time Frame
Four weeks
Title
Oswestry Disability Index (OD) - NexWave vs. Control
Description
ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Andrud, PhD
Phone
(800) 495-6670
Ext
3457
Email
kandrud@zynex.com
Facility Information:
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Brewer
Phone
336-765-6181
Ext
146
Email
JBrewer@ccrpain.com
First Name & Middle Initial & Last Name & Degree
James North, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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