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NCT Number: NCT06421558

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 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.

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Key information

Conditions

Radiculopathy Lumbar Radiculopathy Multiple Sites Radiculopathy Sacral

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NCEPT Physical Therapy, Escondido, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neubie Direct Current Electrical Stimulation Device

Device

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

transcutaneous electrical stimulation

Device

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

Other names: TENS

Primary outcomes

  1. 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.

  2. 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.

  3. H-Reflex

    Time frame: 12 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.

  4. 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

  5. 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. EMG detection of spontaneous electrical activity

    Time frame: 12 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

  7. Straight Leg Raise Test

    Time frame: Pre-intervention

    Straight Leg Raise Test degrees of movement

  8. Straight Leg Raise Test

    Time frame: 6 weeks

    Straight Leg Raise Test degrees of movement

  9. Straight Leg Raise Test

    Time frame: 12 weeks

    Straight Leg Raise Test degrees of movement

  10. Oswestry Disability Index

    Time frame: Pre-intervention

    Oswestry Disability Index Questionnaire Score

  11. Oswestry Disability Index

    Time frame: 6 weeks

    Oswestry Disability Index Questionnaire Score

  12. Oswestry Disability Index

    Time frame: 12 weeks

    Oswestry Disability Index Questionnaire Score

  13. Numeric Pain Rating Scale

    Time frame: Pre-intervention

    Numeric Pain Rating scale for pain

  14. Numeric Pain Rating Scale

    Time frame: 6 weeks

    Numeric Pain Rating Scale for pain

  15. Numeric Pain Rating Scale

    Time frame: 12 weeks

    Numeric Pain Rating Scale for pain

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitrios Kostopoulos, MD, PhD, DPT

CONTACT

[email protected]

9175382242

Ramona von Leden, PhD

CONTACT

[email protected]

5303832292

Sponsors and collaborators

Lead sponsor

NeuFit - Neurological Fitness and Education

Industry

Registry information

Official study title

Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 20, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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