Recruiting

Direct Current StimulationImpact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

Sponsor:

NeuFit - Neurological Fitness and Education

Code:

NCT06421558

Conditions

Radiculopathy Lumbar

Radiculopathy Sacral

Radiculopathy Multiple Sites

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neubie Direct Current Electrical Stimulation Device

Transcutaneous Electrical Stimulation

Study Details

Brief 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

Radiculopathy Lumbar

Radiculopathy Sacral

Radiculopathy Multiple Sites

Study ID

NCT06421558

Start date

Apr 1, 2024

Status verified date

Jul, 2024

Completion date

Aug 1, 2025

Anticipated

Primary completion date

May 1, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Must show evidence of lumbo-sacral radiculopathy as determined by EMG and straight leg raise test.
Must be able to attend weekly sessions for the 6-week period of the study (no extended travel)
Must be at least 18 years old.

Exclusion Criteria:

Currently pregnant
Cardiac pacemaker
Active or recent cancer
Active or recent blood clots
History of epilepsy
Open wounds
Spinal fusion surgery

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neubie Direct Current Electrical Stimulation Device

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.

other: Transcutaneous Electrical Stimulation

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.

Interventions

Neubie Direct Current Electrical Stimulation Device

Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.

Transcutaneous Electrical Stimulation

Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.

Primary outcome measure

H-Reflex [ Time Frame: Pre-intervention ]
H-Reflex [ Time Frame: 6 weeks ]
H-Reflex [ Time Frame: 12 weeks ]
EMG detection of spontaneous electrical activity [ Time Frame: Pre-intervention ]
EMG detection of spontaneous electrical activity [ Time Frame: 6 weeks ]
EMG detection of spontaneous electrical activity [ Time Frame: 12 weeks ]
Straight Leg Raise Test [ Time Frame: Pre-intervention ]
Straight Leg Raise Test [ Time Frame: 6 weeks ]
Straight Leg Raise Test [ Time Frame: 12 weeks ]
Oswestry Disability Index [ Time Frame: Pre-intervention ]
Oswestry Disability Index [ Time Frame: 6 weeks ]
Oswestry Disability Index [ Time Frame: 12 weeks ]
Numeric Pain Rating Scale [ Time Frame: Pre-intervention ]
Numeric Pain Rating Scale [ Time Frame: 6 weeks ]
Numeric Pain Rating Scale [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Dimitrios Kostopoulos, MD, PhD, DPT

9175382242 dimi@handsonpt.org

Ramona von Leden, PhD

5303832292 ramona.vonleden@neu.fit

Locations

NCEPT Physical Therapy

Recruiting

Escondido, California, United States, 92025

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

APEX Physical Therapy

Recruiting

Cape Coral, Florida, United States, 33991

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

Catalyst Physical Therapy

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

APEX Physical Therapy

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

Kinetix Haile Plantation

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

Kinetix Arbor Greens - Jonesville

Recruiting

Gainesville, Florida, United States, 32669

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

Adams Physical Therapy Services

Recruiting

Portland, Indiana, United States, 47371

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

KORT Bardstown

Recruiting

Bardstown, Kentucky, United States, 40004

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

KORT Sheperdsville

Recruiting

Shepherdsville, Kentucky, United States, 40165

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

Hands On Physical Therpay

Recruiting

Astoria, New York, United States, 11106

Contacts

Dimitrios Kostopoulos, MD, PhD, DPT

917-538-2242 dimi@handsonpt.com

WellHealth Physical Therapy

Recruiting

Deer Park, New York, United States, 11729

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

WellHealth Physical Therapy

Recruiting

Hicksville, New York, United States, 11801

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

Hands On Physical Therapy of Queens Village

Recruiting

Queens Village, New York, United States, 11428

Contacts

Dimitrios Kostopolous, MD, PhD, DPT

917-538-2242 dimi@handsonpt.com

Courcier Clinic

Recruiting

Edmond, Oklahoma, United States, 73013

Contacts

Dimitrios Kostopolous

dimi@handsonpt.com

Spine & Rehab Specialists

Recruiting

El Paso, Texas, United States, 79925

Contacts

Dimi Kostopolous

dimi@handsonpt.com

Spine & Rehab Specialists

Recruiting

El Paso, Texas, United States, 79936

Contacts

Dimitrios Kostopoulos

dimi@handsonpt.org

More Information

Sponsor

NeuFit - Neurological Fitness and Education

Last update posted

Jul 29, 2024

Last verified

Jul, 2024

Keywords

electrical stimulation
direct current
e-stim
neubie
emg

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NeuFit - Neurological Fitness and Education on 2024-07-29.