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Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy
NCT06421558 · View on ClinicalTrials.gov ↗
Study Summary
This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating lumbosacral radiculopathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about its impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit in clinical physical therapy treatment of radiculopathy. Outcomes measured will include: pain intensity, functional status, neurological status, electrophysiological changes and patient satisfaction.
Conditions Studied
Interventions
- DEVICE Transcutaneous Electrical Stimulation
- DEVICE Neubie Direct Current Electrical Stimulation Device
Study Locations (16)
Florida
- APEX Physical Therapy — Cape Coral
- Catalyst Physical Therapy — Clearwater
- APEX Physical Therapy — Fort Myers
- Kinetix Haile Plantation — Gainesville
- Kinetix Arbor Greens - Jonesville — Gainesville
New York
- Hands On Physical Therpay — Astoria
- WellHealth Physical Therapy — Deer Park
- WellHealth Physical Therapy — Hicksville
- Hands On Physical Therapy of Queens Village — Queens Village
Kentucky
- KORT Bardstown — Bardstown
- KORT Sheperdsville — Shepherdsville
Texas
- Spine & Rehab Specialists — El Paso
- Spine & Rehab Specialists — El Paso
California
- NCEPT Physical Therapy — Escondido
Indiana
- Adams Physical Therapy Services — Portland
Oklahoma
- Courcier Clinic — Edmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2025-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06421558
The ClinicalTrials.gov registry entry for NCT06421558 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeuFit - Neurological Fitness and Education, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Radiculopathy Lumbar appearing as the primary indexed condition, and to 2 interventions — of which Transcutaneous Electrical Stimulation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06421558 reports 16 study locations spanning 7 distinct geographic areas — top geographies include Florida, New York, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06421558 about?
NCT06421558 is a clinical study titled "Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy". This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating lumbosacral radiculopathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is ...
What is the current status of trial NCT06421558?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2024-04-01. Estimated completion is 2025-08-01.
What conditions does trial NCT06421558 study?
This clinical trial studies the following conditions: Radiculopathy Lumbar, Radiculopathy Sacral, Radiculopathy Multiple Sites. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06421558?
The interventions under investigation include: Transcutaneous Electrical Stimulation (DEVICE), Neubie Direct Current Electrical Stimulation Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06421558?
This trial is sponsored by NeuFit - Neurological Fitness and Education, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06421558 being conducted?
This trial has 16 study locations across California, Florida, Indiana, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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