What is the mechanism of action of this treatment?

Electrical stimulation therapies like TENS and IFC are commonly used to treat chronic lower back pain by blocking pain signals and promoting the release of endorphins, the body's natural painkillers. TENS works by delivering low-voltage electrical currents through the skin to stimulate nerve fibers, which can inhibit the transmission of pain signals to the brain and spinal cord. IFC uses a similar principle but employs medium-frequency currents that intersect to create a low-frequency effect deep within the tissues, providing pain relief and reducing inflammation. These mechanisms are crucial for chronic lower back pain patients as they offer a non-invasive, drug-free option to manage pain, improve mobility, and enhance quality of life.

What side effects are associated with this type of intervention?

The most common treatments for chronic lower back pain that involve electrical stimulation, such as Transcutaneous Electrical Nerve Stimulation (TENS) and Interferential Current (IFC), generally have minimal side effects. Patients may experience mild skin irritation or redness at the site of electrode placement. Some individuals might find the sensation uncomfortable or experience muscle twitching. Serious side effects are rare, but improper use can lead to burns or increased pain. Overall, these treatments are considered safe when used correctly under professional guidance.

What prior FDA approvals exist?

The FDA has approved Transcutaneous Electrical Nerve Stimulation (TENS) for the treatment of chronic lower back pain. TENS works by delivering low-voltage electrical currents through the skin to stimulate nerves and reduce pain. Interferential Current (IFC) therapy, which also uses electrical stimulation to alleviate pain, is another modality studied for chronic lower back pain, although specific FDA approval details for IFC are less clear. Both TENS and IFC aim to block pain signals and promote the release of endorphins, providing non-pharmacologic pain relief options.

What other types of research exist?

Promising novel alternatives to the NexWave device for chronic lower back pain patients include: 1) Spinal Cord Stimulation (SCS), particularly high-frequency (10 kHz) SCS, which has shown efficacy in reducing pain and improving quality of life. 2) Acupuncture, which has demonstrated benefits in managing chronic pain conditions. 3) Integrative therapies such as physical exercise and biofield therapies (e.g., Reiki, therapeutic touch) that have been recommended for pain management in cancer patients and may be applicable to CLBP.

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Behavioural Intervention

TENS and IFC for Chronic Lower Back Pain

N/A

Recruiting

Led By James M. North, MD

Research Sponsored by Zynex Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Are you currently on opioids?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects from devices like NexWave may include skin irritation where it's applied due to adhesives or electrical stimulation discomfort. Serious side effects are rare but could involve worsening pain if improperly used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am willing and able to follow all study requirements.

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Analogue Scale Pain Rating - NexWave vs. Control

Visual Analogue Scale Pain Rating - NexWave vs. Sham

Secondary study objectives

Oswestry Disability Index (OD) - NexWave vs. Control

Oswestry Disability Index (ODI) - NexWave vs. Sham

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Device TENSExperimental Treatment1 Intervention

Group II: Device IFCExperimental Treatment1 Intervention

Group III: ControlActive Control1 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 TENSPlacebo Group1 Intervention

Group V: Sham IFCPlacebo Group1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Electrical stimulation therapies like TENS and IFC are commonly used to treat chronic lower back pain by blocking pain signals and promoting the release of endorphins, the body's natural painkillers. TENS works by delivering low-voltage electrical currents through the skin to stimulate nerve fibers, which can inhibit the transmission of pain signals to the brain and spinal cord. IFC uses a similar principle but employs medium-frequency currents that intersect to create a low-frequency effect deep within the tissues, providing pain relief and reducing inflammation. These mechanisms are crucial for chronic lower back pain patients as they offer a non-invasive, drug-free option to manage pain, improve mobility, and enhance quality of life.

Inhibition of primate spinothalamic tract cells by TENS.Effect of TENS on pain relief in patients with degenerative disc disease in lumbosacral spine.[Devices for the relief and evaluation of pain: preface and comments].