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Electrical Stimulation for Pinched Nerve

N/A

Recruiting

Research Sponsored by NeuFit - Neurological Fitness and Education

Eligibility Criteria Checklist

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

Must have

Must show evidence of lumbo-sacral radiculopathy as determined by EMG and straight leg raise test

Must be at least 18 years old

Must not have

Open wounds

Active or recent blood clots

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial will compare two types of electrical stimulation, alternating current and direct current, to see which one is more effective in treating lumbosacral radiculopathy. The direct current stimulation is

Who is the study for?

This trial is for individuals experiencing lumbosacral radiculopathy, commonly known as a pinched nerve in the lower back or sacrum area. Participants should be seeking physical therapy and have no contraindications to electrical stimulation.

What is being tested?

The study compares two types of electrical stimulation: a new direct current device called Neubie and the traditional TENS unit. It aims to determine which is more effective at reducing pain and improving function, neurological status, and patient satisfaction in radiculopathy treatment.

What are the potential side effects?

Potential side effects from both electrical stimulation methods may include skin irritation at the site of electrode placement, discomfort during treatment, muscle twitching, or unusual sensations like tingling.

Eligibility Criteria

Inclusion Criteria

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

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My tests show nerve issues in my lower back.

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I am 18 years old or older.

Exclusion Criteria

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

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I have open wounds.

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I have had blood clots recently or currently have them.

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I currently have cancer or had it recently.

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I have a history of epilepsy.

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I have had spinal fusion surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

EMG detection of spontaneous electrical activity

H-Reflex

Numeric Pain Rating Scale

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Transcutaneous Electrical StimulationExperimental Treatment1 Intervention

The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min of various physical therapy exercises with TENS application.

Group II: Neubie Direct Current Electrical Stimulation DeviceExperimental Treatment1 Intervention

The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include 30 min of various physical therapy exercises with the Neubie.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neubie Direct Current Electrical Stimulation Device

2022

N/A

~150

Transcutaneous Electrical Stimulation

2023

N/A

~40