Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

May 14, 2024 updated by: NeuFit - Neurological Fitness and Education

Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-term symptoms and severity of lumbosacral and thoracic radiculopathy, participants will enroll in a 6-week treatment regimen at one of 9 Hands-On Physical Therapy associated clinic sites listed included in application. The first session will consist of an intake evaluation session that will include: Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, and Electrophysiological evaluation to determine the nerve function. These tests will serve as baseline (and a within subject control) for the intervention.

Participants will then undergo a specialized radiculopathy protocol that includes traditional PT therapy as well as treatment with the Neubie (or traditional electrical stimulation) both during PT exercises and as additional treatment after sessions. Subjects receive an evaluation session that includes Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, and Electrophysiological evaluation to determine the nerve function.

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.

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.

At the end of the 12 sessions of treatment, subjects receive a final evaluation session that includes Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, Electrophysiological evaluation to determine the nerve function, and a patient satisfaction questionnaire to assess patient satisfaction with the treatment. Participants will receive 12 treatments over 6 weeks. Measurement of these variables will provide both quantitative and qualitative data on the severity of radiculopathy symptoms (see "Tools for data collection" below).

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dimitrios Kostopoulos, MD, PhD, DPT
  • Phone Number: 9175382242
  • Email: dimi@handsonpt.org

Study Contact Backup

Study Locations

  • United States
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • NCEPT Physical Therapy
        • Contact:
    • Florida
      • Cape Coral, Florida, United States, 33991
        • Recruiting
        • APEX Physical Therapy
        • Contact:
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Catalyst Physical Therapy
        • Contact:
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • APEX Physical Therapy
        • Contact:
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • Kinetix Haile Plantation
        • Contact:
      • Gainesville, Florida, United States, 32669
        • Recruiting
        • Kinetix Arbor Greens - Jonesville
        • Contact:
    • Indiana
      • Portland, Indiana, United States, 47371
        • Recruiting
        • Adams Physical Therapy Services
        • Contact:
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Shepherdsville, Kentucky, United States, 40165
    • New York
      • Astoria, New York, United States, 11106
        • Recruiting
        • Hands On Physical Therpay
        • Contact:
          • Dimitrios Kostopoulos, MD, PhD, DPT
          • Phone Number: 917-538-2242
          • Email: dimi@handsonpt.com
      • Deer Park, New York, United States, 11729
        • Recruiting
        • WellHealth Physical Therapy
        • Contact:
      • Hicksville, New York, United States, 11801
        • Recruiting
        • WellHealth Physical Therapy
        • Contact:
      • Queens Village, New York, United States, 11428
        • Recruiting
        • Hands On Physical Therapy of Queens Village
        • Contact:
          • Dimitrios Kostopolous, MD, PhD, DPT
          • Phone Number: 917-538-2242
          • Email: dimi@handsonpt.com
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
    • Texas
      • El Paso, Texas, United States, 79936
        • Recruiting
        • Spine & Rehab Specialists
        • Contact:
      • El Paso, Texas, United States, 79925
        • Recruiting
        • Spine & Rehab Specialists
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Neubie Direct Current Electrical Stimulation Device
Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.
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.
Device: Transcutaneous Electrical Stimulation
Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.
Other Names:
  • TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H-Reflex
Time Frame: 6 weeks
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.
6 weeks
H-Reflex
Time Frame: Pre-intervention
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.
Pre-intervention
EMG detection of spontaneous electrical activity
Time Frame: Pre-intervention
EMG detection of presence of degree of spontaneous electrical activity such as fibrillation potentials and positive sharp waves of muscles innervated by L4, L5, and S1 nerve roots
Pre-intervention
EMG detection of spontaneous electrical activity
Time Frame: 6 weeks
EMG detection of presence of degree of spontaneous electrical activity such as fibrillation potentials and positive sharp waves of muscles innervated by L4, L5, and S1 nerve roots
6 weeks
Straight Leg Raise Test
Time Frame: Pre-intervention
Straight Leg Raise Test degrees of movement
Pre-intervention
Straight Leg Raise Test
Time Frame: 6 weeks
Straight Leg Raise Test degrees of movement
6 weeks
Oswestry Disability Index
Time Frame: Pre-intervention
Oswestry Disability Index Questionnaire Score
Pre-intervention
Oswestry Disability Index
Time Frame: 6 weeks
Oswestry Disability Index Questionnaire Score
6 weeks
Visual Analog Score
Time Frame: Pre-intervention
Visual Analog Score for pain
Pre-intervention
Visual Analog Score
Time Frame: 6 weeks
Visual Analog Score for pain
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuFit - Neurological Fitness and Education

Investigators

  • Study Director: Ramona von Leden, PhD, NeuFit - Neurological Fitness and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00077736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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