Chronic Lower Back Pain > Interferential Current (IFC)

TENS and IFC for Chronic Lower Back Pain

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen By James North, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Zynex Medical, Inc.

No Placebo Group

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}

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 am between 18 and 70 years old, or older if allowed by law.

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?

Participant Groups

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.

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

Find A Clinic Near You

Research locations nearby Select from list below to view details:

McGreevy NeuroHealth Saint Augustine, FL

DBPS Research Greenwood Village, CO

Peachtree Orthopedics Atlanta, GA

Horizon Clinical Research Jasper, GA

More Trial Locations

Who is running the clinical trial?

Zynex Medical, Inc. Lead Sponsor

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] Electrotherapy, including theTENS and interferential current (IFC) is one of the most frequently used treatments in physical therapy in patients with low back pain. The aim of this study was to assess the influence of TENS and IFC on pain relief and to compare the analgesic efficacy of the two currents.

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

Meta-analysis of transcutaneous electrical nerve stimulation for relief of spinal pain. [2022] We conducted a systematic review and meta-analysis analysing the existing data on transcutaneous electrical nerve stimulation (TENS) or interferential current (IFC) for chronic low back pain (CLBP) and/or neck pain (CNP) taking into account intensity and timing of stimulation, examining pain, function and disability. Seven electronic databases were searched for TENS or IFC treatment in non-specific CLBP or CNP. Four reviewers independently selected randomized controlled trials (RCTs) of TENS or IFC intervention in adult individuals with non-specific CLBP or CNP. Primary outcomes were for self-reported pain intensity and back-specific disability. Two reviewers performed quality assessment, and two reviewers extracted data using a standardized form. Nine RCTs were selected (eight CLBP; one CNP), and seven studies with complete data sets were included for meta-analysis (655 participants). For CLBP, meta-analysis shows TENS/IFC intervention, independent of time of assessment, was significantly different from placebo/control (p

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] To compare the immediate analgesic effect of transcutaneous nerve stimulation (TENS) and interferential current (IFC), with different combinations of parameters, in individuals with chronic low back pain (CLBP).

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] Transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) are pain electrotherapies with questioned efficacy. Studies of their effects on tactile acuity of individuals with nonspecific chronic low back pain (NSCLBP) are limited, hence, this study.

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] Interferential currents (IFC) and transcutaneous electrical nerve stimulation (TENS) are used for pain management. This study compared the analgesic effects of IFC and TENS on experimentally induced ischemic pain in otherwise pain-free subjects using a modified version of the submaximal-effort tourniquet technique.