A Review of Lumbar Radiculopathy, Diagnosis, and Treatment.
James A Berry, Christopher Elia, Harneel S Saini...
https://pubmed.ncbi.nlm.nih.gov/31788391Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06421558
Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy
Led by NeuFit - Neurological Fitness and Education · Updated on 2024-07-29
150
Participants Needed
16
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of electrical stimulation, alternating current and direct current, as additional treatments for lumbosacral radiculopathy. This study aims to compare the effects of a novel direct current device called the Neubie against a traditional TENS unit during physical therapy. The goal is to assess their impact on pain, function, nerve status, electrophysiology, and patient satisfaction. Participants will enroll in a 6-week treatment program at one of several physical therapy clinics. They will be randomly assigned to receive 12 sessions of physical therapy exercises combined with either the Neubie direct current device or the traditional TENS device, each session lasting about 30 minutes. If symptoms persist after 6 weeks, participants may continue treatment for up to 12 more sessions over an additional 6 weeks, totaling 24 sessions in 12 weeks. Throughout the study, participants will undergo evaluations before treatment, at 6 weeks, and at 12 weeks. These include pain rating scales, functional disability questionnaires, nerve irritation tests, electrophysiological assessments, and patient satisfaction surveys. The study will monitor nerve reflexes, muscle electrical activity, and physical function to understand treatment effects. Total participation lasts up to 12 weeks depending on symptom improvement and treatment continuation.
CONDITIONS
Brief Title
Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Currently pregnant
- Cardiac pacemaker
- Active or recent cancer
- Active or recent blood clots
- History of epilepsy
- Open wounds
- Spinal fusion surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants undergo 12 physical therapy sessions over 6 weeks that include 30 minutes of exercises combined with either the Neubie direct current electrical stimulation device or traditional transcutaneous electrical nerve stimulation (TENS).
12 sessions (in-person)
Treatment
Duration - Up to 6 additional weeks
If symptoms persist after the initial 6 weeks, participants may continue treatment with up to 12 additional physical therapy sessions over 6 more weeks with the same therapy approach.
Up to 12 additional sessions (in-person)
Trial Site Locations
Total: 16 locations
1
NCEPT Physical Therapy
Escondido, California, United States, 92025
Actively Recruiting
2
APEX Physical Therapy
Cape Coral, Florida, United States, 33991
Actively Recruiting
3
Catalyst Physical Therapy
Clearwater, Florida, United States, 33756
Actively Recruiting
4
APEX Physical Therapy
Fort Myers, Florida, United States, 33908
Actively Recruiting
5
Kinetix Haile Plantation
Gainesville, Florida, United States, 32608
Actively Recruiting
6
Kinetix Arbor Greens - Jonesville
Gainesville, Florida, United States, 32669
Actively Recruiting
7
Adams Physical Therapy Services
Portland, Indiana, United States, 47371
Actively Recruiting
8
KORT Bardstown
Bardstown, Kentucky, United States, 40004
Actively Recruiting
9
KORT Sheperdsville
Shepherdsville, Kentucky, United States, 40165
Actively Recruiting
10
Hands On Physical Therpay
Astoria, New York, United States, 11106
Actively Recruiting
11
WellHealth Physical Therapy
Deer Park, New York, United States, 11729
Actively Recruiting
12
WellHealth Physical Therapy
Hicksville, New York, United States, 11801
Actively Recruiting
13
Hands On Physical Therapy of Queens Village
Queens Village, New York, United States, 11428
Actively Recruiting
14
Courcier Clinic
Edmond, Oklahoma, United States, 73013
Actively Recruiting
15
Spine & Rehab Specialists
El Paso, Texas, United States, 79925
Actively Recruiting
16
Spine & Rehab Specialists
El Paso, Texas, United States, 79936
Actively Recruiting
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Research Team
D
Dimitrios Kostopoulos, MD, PhD, DPT
R
Ramona von Leden, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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