Non-Specific Chronic Lower Back PainNCT05972889
Randomized Blinded Evaluation of the Effects of TENS and IFC Compared to a Sham Device and SOC in Patients With Non-Specific CLBP
A study testing NexWave in people with Non-Specific Chronic Lower Back Pain, run by Zynex Medical, Inc. at 8 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Specific Chronic Lower Back Pain
- What is being tested?
- NexWave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Nov 2023to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Peachtree Orthopedics
Atlanta, Georgia, 30327
Applied Pain Institute, LLC
Bloomington, Illinois, 61701
One Oak Medical
Congers, New York, 10920
DBPS Research
Greenwood Village, Colorado, 80111
Horizon Clinical Research
Jasper, Georgia, 30143
Summit Brain, Spine and Orthopedics
Lehi, Utah, 84043
McGreevy NeuroHealth
Saint Augustine, Florida, 32095
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
About this study
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
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
- Being tested
- NexWave, Sham
- Keywords
- TENS, IFC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexWaveDevice
Device subjects receive designated treatment mode twice daily for up to 8 weeks.
ShamDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Device TENS | Experimental | Not described Receives: Device: NexWave |
| Device IFC | Experimental | Not described Receives: Device: NexWave |
| Sham TENS | Sham comparator | Not described Receives: Device: Sham |
| Sham IFC | Sham comparator | Not described Receives: Device: Sham |
| Control | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
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.
Measured: Four weeks
Secondary outcomes (2)
Oswestry Disability Index (ODI) - NexWave vs. Sham
ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects.
Measured: Four weeks
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start2 Nov 2023
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Specific Chronic Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zynex Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Gilmore, MD, Principal investigator, The Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972889
- Sponsor's protocol ID
- ZMI-2023-NexWave-vs-Sham
- Status last verified
- Oct 2025
- First submitted
- 25 Jul 2023
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05972889
- Acronym / sponsor ID
- ZMI-2023-NexWave-vs-Sham
- Conditions
- Non-Specific Chronic Lower Back Pain
- Keywords
- TENS, IFC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Zynex Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Device TENS | Experimental | Device: NexWave |
| Device IFC | Experimental | Device: NexWave |
| Sham TENS | Sham comparator | Device: Sham |
| Sham IFC | Sham comparator | Device: Sham |
| Control | No intervention | –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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 18-70, or older if specified by law
- Non-specific chronic lower back pain defined as:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NexWaveDevice subjects receive designated treatment mode twice daily for up to 8 weeks. | Device | Device IFC, Device TENS |
| ShamSham 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). | Device | Sham IFC, Sham TENS |
Primary outcome
Visual Analogue Scale Pain Rating - NexWave vs. Sham
Time frame: 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
Time frame: Four weeks
VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.
2 secondary outcomes
Oswestry Disability Index (ODI) - NexWave vs. Sham
Time frame: Four weeks
Oswestry Disability Index (OD) - NexWave vs. Control
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Gilmore, MD principal investigator
The Center for Clinical Research
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexWave in people with Non-Specific Chronic Lower Back Pain, run by Zynex Medical, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Pain Rating - NexWave vs. Sham (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.