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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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EMG detection of spontaneous electrical activity
H-Reflex
Numeric Pain Rating Scale
+2 more

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

Find a Location

Who is running the clinical trial?

NeuFit - Neurological Fitness and EducationLead Sponsor
3 Previous Clinical Trials
154 Total Patients Enrolled
Ramona von Leden, PhDStudy DirectorNeuFit - Neurological Fitness and Education
1 Previous Clinical Trials
148 Total Patients Enrolled
~81 spots leftby May 2025
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