TENS and IFC for Chronic Lower Back Pain

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

336 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device called NexWave that uses small electrical currents to reduce back pain. It targets people with chronic low back pain that doesn't have a specific cause. The device works by sending tiny shocks through the skin to block pain signals from reaching the brain. Similar methods have been used to treat chronic low back pain, showing varying degrees of effectiveness.

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 data supports the effectiveness of the treatment TENS and IFC for chronic lower back pain?

Research shows that both TENS (Transcutaneous Electrical Nerve Stimulation) and IFC (Interferential Current) can help reduce pain in people with chronic lower back pain. A meta-analysis found that these treatments were more effective than a placebo in reducing pain and improving function. ^{1 2 3 4 5}

Is TENS and IFC safe for humans?

Research on TENS and IFC, used for pain management, generally indicates they are safe for humans, with studies often focusing on their effectiveness rather than safety concerns. ^{1 2 3 4 5}

How does the treatment TENS and IFC for chronic lower back pain differ from other treatments?

TENS and IFC are unique because they use electrical currents to relieve pain, which is different from medications or physical therapy exercises. These treatments are non-invasive and can provide immediate pain relief by stimulating nerves through the skin. ^{1 2 3 4 5}

Research Team

Christopher Gilmore, MD

Principal Investigator

The Center for Clinical Research

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

[Comparison of the analgesic effect of interferential current (IFC) and TENS in patients with low back pain]. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of transcutaneous electrical nerve stimulation for relief of spinal pain. [2022]

3. United States 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. [2021]

4. United States 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. [2022]

5. United States 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. [2022]