Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy

Last updated: July 25, 2024
Sponsor: NeuFit - Neurological Fitness and Education
Overall Status: Active - Recruiting

Phase

N/A

Condition

Radiculopathy

Treatment

Transcutaneous Electrical Stimulation

Neubie Direct Current Electrical Stimulation Device

Clinical Study ID

NCT06421558
Pro00077736
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must show evidence of lumbo-sacral radiculopathy as determined by EMG and straightleg raise test.

  • Must be able to attend weekly sessions for the 6-week period of the study (noextended travel)

  • Must be at least 18 years old.

Exclusion

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

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Transcutaneous Electrical Stimulation
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
August 01, 2025

Study 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 16 Hands-On Physical Therapy associated clinic sites listed included in application. The first session will consist of an intake evaluation session that will include: Numeric Pain Scale 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 Numeric Pain Scale 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 an evaluation session that includes Numeric Pain Scale 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).

If symptoms of radiculopathy are still present at the 6 week assessment, participants will have the option to continue treatment for up to an additional 12 sessions over 6 more weeks, to a possible maximum of 24 sessions in 12 weeks. Participants will receive a final outcome evaluation session that includes Numeric Pain Rating Scale 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.

Connect with a study center

  • NCEPT Physical Therapy

    Escondido, California 92025
    United States

    Active - Recruiting

  • APEX Physical Therapy

    Cape Coral, Florida 33991
    United States

    Active - Recruiting

  • Catalyst Physical Therapy

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • APEX Physical Therapy

    Fort Myers, Florida 33908
    United States

    Active - Recruiting

  • Kinetix Arbor Greens - Jonesville

    Gainesville, Florida 32669
    United States

    Active - Recruiting

  • Kinetix Haile Plantation

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Adams Physical Therapy Services

    Portland, Indiana 47371
    United States

    Active - Recruiting

  • KORT Bardstown

    Bardstown, Kentucky 40004
    United States

    Active - Recruiting

  • KORT Sheperdsville

    Shepherdsville, Kentucky 40165
    United States

    Active - Recruiting

  • Hands On Physical Therpay

    Astoria, New York 11106
    United States

    Active - Recruiting

  • WellHealth Physical Therapy

    Deer Park, New York 11729
    United States

    Active - Recruiting

  • WellHealth Physical Therapy

    Hicksville, New York 11801
    United States

    Active - Recruiting

  • Hands On Physical Therapy of Queens Village

    Queens Village, New York 11428
    United States

    Active - Recruiting

  • Courcier Clinic

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Spine & Rehab Specialists

    El Paso, Texas 79925
    United States

    Active - Recruiting

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