Using electrical stimulation to treat lumbosacral radiculopathy
Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy
This study is testing if a new type of electrical stimulation can help people with lumbosacral radiculopathy feel less pain and improve their function compared to the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NeuFit - Neurological Fitness and Education Industry-sponsored |
| Locations | 16 sites (Escondido, California and 15 other locations) |
| Trial ID | NCT06421558 on ClinicalTrials.gov |
What this trial studies
This study compares the efficacy of direct current electrical stimulation using the Neubie device against traditional alternating current stimulation in treating lumbosacral radiculopathy. Participants will undergo a 6-week treatment regimen that includes both physical therapy and electrical stimulation sessions. Outcomes will be measured through pain intensity, functional status, neurological assessments, and patient satisfaction. The study aims to provide insights into the effectiveness of a less common treatment method in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with lumbosacral radiculopathy and can commit to weekly sessions for six weeks.
Not a fit: Patients with conditions such as active cancer, recent blood clots, or those who have had spinal fusion surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment option for patients suffering from lumbosacral radiculopathy.
How similar studies have performed: While traditional electrical stimulation methods have been widely used, the specific application of direct current stimulation in this context is less common and may represent a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Escondido, California and 15 other locations
- NCEPT Physical Therapy — Escondido, California, United States (Recruiting)
- APEX Physical Therapy — Cape Coral, Florida, United States (Recruiting)
- Catalyst Physical Therapy — Clearwater, Florida, United States (Recruiting)
- APEX Physical Therapy — Fort Myers, Florida, United States (Recruiting)
- Kinetix Haile Plantation — Gainesville, Florida, United States (Recruiting)
- Kinetix Arbor Greens - Jonesville — Gainesville, Florida, United States (Recruiting)
- Adams Physical Therapy Services — Portland, Indiana, United States (Recruiting)
- KORT Bardstown — Bardstown, Kentucky, United States (Recruiting)
- KORT Sheperdsville — Shepherdsville, Kentucky, United States (Recruiting)
- Hands On Physical Therpay — Astoria, New York, United States (Recruiting)
- WellHealth Physical Therapy — Deer Park, New York, United States (Recruiting)
- WellHealth Physical Therapy — Hicksville, New York, United States (Recruiting)
- Hands On Physical Therapy of Queens Village — Queens Village, New York, United States (Recruiting)
- Courcier Clinic — Edmond, Oklahoma, United States (Recruiting)
- Spine & Rehab Specialists — El Paso, Texas, United States (Recruiting)
- Spine & Rehab Specialists — El Paso, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Dimitrios Kostopoulos, MD, PhD, DPT
- Email: dimi@handsonpt.org
- Phone: 9175382242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.