Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy
- Conditions
- Radiculopathy Multiple SitesRadiculopathy LumbarRadiculopathy Sacral
- Interventions
- Device: Neubie Direct Current Electrical Stimulation DeviceDevice: Transcutaneous Electrical Stimulation
- Registration Number
- NCT06421558
- Lead Sponsor
- NeuFit - Neurological Fitness and Education
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- Currently pregnant
- Cardiac pacemaker
- Active or recent cancer
- Active or recent blood clots
- History of epilepsy
- Open wounds
- Spinal fusion surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neubie Direct Current Electrical Stimulation Device 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. Transcutaneous Electrical Stimulation 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.
- Primary Outcome Measures
Name Time Method H-Reflex 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.
EMG detection of spontaneous electrical activity 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
Straight Leg Raise Test 12 weeks Straight Leg Raise Test degrees of movement
Oswestry Disability Index 12 weeks Oswestry Disability Index Questionnaire Score
Numeric Pain Rating Scale 12 weeks Numeric Pain Rating Scale for pain
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Hands On Physical Therpay
🇺🇸Astoria, New York, United States
Spine & Rehab Specialists
🇺🇸El Paso, Texas, United States
NCEPT Physical Therapy
🇺🇸Escondido, California, United States
WellHealth Physical Therapy
🇺🇸Hicksville, New York, United States
Hands On Physical Therapy of Queens Village
🇺🇸Queens Village, New York, United States
Courcier Clinic
🇺🇸Edmond, Oklahoma, United States
Catalyst Physical Therapy
🇺🇸Clearwater, Florida, United States
KORT Bardstown
🇺🇸Bardstown, Kentucky, United States
APEX Physical Therapy
🇺🇸Fort Myers, Florida, United States
KORT Sheperdsville
🇺🇸Shepherdsville, Kentucky, United States
Adams Physical Therapy Services
🇺🇸Portland, Indiana, United States
Kinetix Haile Plantation
🇺🇸Gainesville, Florida, United States
Kinetix Arbor Greens - Jonesville
🇺🇸Gainesville, Florida, United States