TENS and IFC for Chronic Lower Back Pain

No longer recruiting at 8 trial locations

Overseen By Abdul R Arain, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zynex Medical, Inc.

Must not be taking: Opioids, Antipsychotics

Disqualifiers: Lumbar surgery, Rheumatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments, Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Current (IFC), to assess their effectiveness in reducing chronic lower back pain. It compares these treatments to a non-working version of the device and the usual care patients receive. The goal is to determine if these electrical therapies can improve pain intensity. Individuals with lower back pain for over three months, primarily in the back or buttocks, may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore innovative pain relief options that could enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on opioid therapy or certain psychiatric medications. It's best to discuss your specific medications with the study team.

What prior data suggests that the NexWave device is safe for treating chronic lower back pain?

Research shows that both interferential current (IFC) and transcutaneous electrical nerve stimulation (TENS) are generally safe for treating pain.

For IFC, studies suggest it can reduce pain without serious side effects. However, evidence does not strongly support its superiority over other treatments. One guideline advises against using IFC for low back pain, focusing on its effectiveness rather than safety.

For TENS, moderate evidence indicates it can lower pain levels without major issues. It is often used for various pain conditions and is considered safe and easy to use. Although TENS hasn't received full FDA approval for pain relief, it has been cleared for safety through a different process.

Overall, both IFC and TENS appear well-tolerated, with few reports of serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because both Interferential Current (IFC) and Transcutaneous Electrical Nerve Stimulation (TENS) offer unique, non-invasive approaches to managing chronic lower back pain. Unlike standard options like pain medications, which can have systemic side effects, these therapies aim to provide relief by directly stimulating nerves through the skin. IFC uses a specific type of electrical current that penetrates deeper into tissues, potentially offering more effective pain relief. TENS, on the other hand, is known for its versatility and ease of use, allowing patients to manage pain through customizable electrical impulses. This trial could reveal new insights into how these devices can be optimized for pain management, offering alternatives to traditional medical treatments.

What evidence suggests that this trial's treatments could be effective for chronic lower back pain?

This trial will compare the effects of Interferential Current (IFC) and Transcutaneous Electrical Nerve Stimulation (TENS) on chronic lower back pain. Research has shown that IFC, which participants in this trial may receive, can reduce pain and improve movement for those with long-term lower back pain. Studies indicate that IFC significantly reduces pain compared to placebo treatments, with many patients experiencing less pain and improved mobility immediately after IFC sessions. In contrast, the benefits of TENS for long-term lower back pain are less certain. Some studies found TENS to be no more effective than placebo treatments, suggesting it might not work for everyone. Overall, IFC appears promising, while TENS remains uncertain for treating long-term lower back pain. ^{1 2 4 6 7}

Who Is on the Research Team?

Christopher Gilmore, MD

Principal Investigator

The Center for Clinical Research

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with non-specific chronic lower back pain lasting over 3 months, a pain rating of at least moderate intensity, and most pain located in the back or buttocks. It excludes those with specific spinal conditions, rheumatic diseases, opioid therapy adherence, electronic implants like pacemakers, pregnant women or those planning pregnancy during the study period.

Inclusion Criteria

I am willing and able to give my consent for treatment.

I am willing and able to follow all study requirements.

I have chronic lower back pain for over 3 months, with most pain in my back or buttocks, not below the knee.

Exclusion Criteria

Are you currently on opioids?

Current implanted cardiac pacemakers, defibrillators, cardiac pumps, spinal stimulators, or other implanted electronic devices

Subjects who are currently enrolled in another investigational study that would directly interfere with the current study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either TENS, IFC, a sham device, or continue with standard care for 4 weeks

4 weeks

Crossover

Participants in the control group have the option to crossover to the NexWave Device group for an additional 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Interferential Current (IFC)
• Sham Device
• Transcutaneous Electrical Nerve Stimulation (TENS)

Trial Overview The study tests two modes of NexWave device: TENS and IFC against a sham (fake) device and standard care to see which is better for reducing non-specific chronic lower back pain. Participants are randomly assigned to one of these treatments without knowing which one they receive.

How Is the Trial Designed?

Group I: Device TENS Experimental Treatment 1 Intervention

Group II: Device IFC Experimental Treatment 1 Intervention

Group III: Control Active Control 1 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).

Group IV: Sham TENS Placebo Group 1 Intervention

Group V: Sham IFC Placebo Group 1 Intervention

Interferential Current (IFC) is already approved in United States, European Union for the following indications:

Approved in United States as Interferential Current for:

• Chronic pain management
• Acute post-operative pain

Approved in European Union as Interferential Stimulation for:

• Pain relief
• Musculoskeletal conditions

Who Is Running the Clinical Trial?

Zynex Medical, Inc.

Lead Sponsor

Trials

2

Recruited

350+

Published Research Related to This Trial

A study involving 60 patients with low back pain found that both TENS and interferential current (IFC) therapies significantly improved pain relief after two weeks of treatment, as measured by the Visual Analog Scale (VAS) and Laitinen modified scale.

There was no significant difference in pain reduction between the two therapies, indicating that both TENS and IFC are equally effective for managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of the analgesic effect of interferential current (IFC) and TENS in patients with low back pain]. Grabiańska, E., Leśniewicz, J., Pieszyński, I., et al.[2015]

In a study involving 30 healthy volunteers, interferential currents (IFC) were found to significantly reduce pain intensity compared to sham electrotherapy, indicating its potential effectiveness for pain management.

However, there was no significant difference in pain relief between IFC and transcutaneous electrical nerve stimulation (TENS), suggesting that both methods may offer similar analgesic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation into the analgesic effects of interferential currents and transcutaneous electrical nerve stimulation on experimentally induced ischemic pain in otherwise pain-free volunteers. Johnson, MI., Tabasam, G.[2022]

Transcutaneous electrical nerve stimulation (TENS) significantly improved tactile acuity in individuals with nonspecific chronic low back pain (NSCLBP), while interferential currents (IFC) did not show any significant effect on tactile acuity.

All three intervention groups, including those receiving TENS and IFC, experienced a significant reduction in pain intensity after five weeks of treatment, indicating that both TENS and IFC can be effective for pain management in NSCLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Transcutaneous Electrical Nerve Stimulation and Interferential Current on Tactile Acuity of Individuals With Nonspecific Chronic Low Back Pain. Tella, BA., Oghumu, SN., Gbiri, CAO.[2022]

In a study involving 280 individuals with chronic low back pain, both transcutaneous nerve stimulation (TENS) and interferential current (IFC) showed immediate pain relief, with IFC at 4 kHz and 100 Hz being particularly effective.

All treatment groups significantly reduced pain intensity compared to placebo, indicating that both TENS and IFC can be effective non-invasive options for managing chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate analgesic effect of transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC) on chronic low back pain: Randomised placebo-controlled trial. Dias, LV., Cordeiro, MA., Schmidt de Sales, R., et al.[2021]

A systematic review of 9 randomized controlled trials involving 655 participants found that transcutaneous electrical nerve stimulation (TENS) or interferential current (IFC) significantly reduced pain intensity in chronic low back pain (CLBP) compared to placebo during therapy, but not immediately after or in the long term.

The review concluded that the evidence for TENS/IFC's effectiveness in improving disability was inconclusive due to the low quality of studies and inconsistent reporting of stimulation parameters, highlighting the need for more rigorous clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of transcutaneous electrical nerve stimulation for relief of spinal pain. Resende, L., Merriwether, E., Rampazo, ÉP., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10562668/

Effectiveness of interferential current in patients with chronic ... Interferential current probably reduces pain intensity and disability immediately post-treatment compared to placebo in patients with chronic ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1413355523000709

Effectiveness of interferential current in patients with ... Interferential current probably reduces pain intensity and disability immediately post-treatment compared to placebo in patients with chronic non-specific low ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26975312/

Effect of interferential current therapy on pain perception ... Conclusions: A two-week transregional interferential current treatment has shown significant short-term efficacy, when compared with a 'usual care' protocol, ...

4. jtss.org jtss.org/articles/the-effect-of-interferential-currents-and-tens-on-pain-and-functionality-in-patients-with-chronic-mechanical-low-back-pain/jtss.galenos.2024.73745

THE EFFECT OF INTERFERENTIAL CURRENTS AND ... It was stated in the literature that IFC provides a significant reduction in pain in low back pain(7). Transcutaneous electrical nerve stimulation can be ...

5. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2024.1346694/full

The effect of EMS, IFC, and TENS on patient-reported ... Interferential current (IFC) was more effective than active control (2 studies), while electromyostimulation (EMS) was generally superior to passive, but not ...

6. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/76859.pdf

MEDICAL POLICY - INTERFERENTIAL STIMULATION ( ... 3 The guideline states “Do not offer interferential therapy for managing low back pain with or without sciatica”. No clinical guidelines were ...

7. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=256

Transcutaneous Electrical Nerve Stimulation for Chronic ... Since TENS for pain relief has only been 510(k) cleared and not PMA approved, it has not been found to have a reasonable assurance of safety and effectiveness ( ...