Radiculopathy LumbarNCT06421558
Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy
A study testing Neubie Direct Current Electrical Stimulation Device and Transcutaneous Electrical Stimulation in people with Radiculopathy Lumbar and Radiculopathy Sacral, run by NeuFit - Neurological Fitness and Education at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy Lumbar, Radiculopathy Sacral, Radiculopathy Multiple Sites
- What is being tested?
- Neubie Direct Current Electrical Stimulation Device and Transcutaneous Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Apr 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Currently pregnant
- Cardiac pacemaker
- Active or recent cancer
- Active or recent blood clots
- History of epilepsy
- Open wounds
- Spinal fusion surgery
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Hands On Physical Therpay
Astoria, New York, 11106
Dimitrios Kostopoulos, MD, PhD, DPT, 917-538-2242, dimi@handsonpt.com
- Recruiting
KORT Bardstown
Bardstown, Kentucky, 40004
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
APEX Physical Therapy
Cape Coral, Florida, 33991
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
Catalyst Physical Therapy
Clearwater, Florida, 33756
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
WellHealth Physical Therapy
Deer Park, New York, 11729
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
Courcier Clinic
Edmond, Oklahoma, 73013
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
Spine & Rehab Specialists
El Paso, Texas, 79925
Dimi Kostopolous, dimi@handsonpt.com
- Recruiting
Spine & Rehab Specialists
El Paso, Texas, 79936
Dimitrios Kostopoulos, dimi@handsonpt.org
- Recruiting
NCEPT Physical Therapy
Escondido, California, 92025
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
APEX Physical Therapy
Fort Myers, Florida, 33908
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
Kinetix Haile Plantation
Gainesville, Florida, 32608
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
Kinetix Arbor Greens - Jonesville
Gainesville, Florida, 32669
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
WellHealth Physical Therapy
Hicksville, New York, 11801
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
Adams Physical Therapy Services
Portland, Indiana, 47371
Dimitrios Kostopolous, dimi@handsonpt.com
- Recruiting
Hands On Physical Therapy of Queens Village
Queens Village, New York, 11428
Dimitrios Kostopolous, MD, PhD, DPT, 917-538-2242, dimi@handsonpt.com
- Recruiting
KORT Sheperdsville
Shepherdsville, Kentucky, 40165
Dimitrios Kostopolous, dimi@handsonpt.com
About this study
Official title: Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy 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.
Read the 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.
- Being tested
- Neubie Direct Current Electrical Stimulation Device, Transcutaneous Electrical Stimulation
- Keywords
- electrical stimulation, direct current, e-stim, neubie, emg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neubie Direct Current Electrical Stimulation DeviceDevice
Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.
Transcutaneous Electrical StimulationDevice
Also called TENS
Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Neubie Direct Current Electrical Stimulation Device | Experimental | 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. Receives: Device: Neubie Direct Current Electrical Stimulation Device |
| Transcutaneous Electrical Stimulation | Other | 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. Receives: Device: Transcutaneous Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-Reflex
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.
Measured: Pre-intervention
H-Reflex
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.
Measured: 6 weeks
H-Reflex
Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.
Measured: 12 weeks
EMG detection of spontaneous electrical activity
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
Measured: Pre-intervention
EMG detection of spontaneous electrical activity
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
Measured: 6 weeks
EMG detection of spontaneous electrical activity
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
Measured: 12 weeks
Straight Leg Raise Test
Straight Leg Raise Test degrees of movement
Measured: Pre-intervention
Straight Leg Raise Test
Straight Leg Raise Test degrees of movement
Measured: 6 weeks
Straight Leg Raise Test
Straight Leg Raise Test degrees of movement
Measured: 12 weeks
Oswestry Disability Index
Oswestry Disability Index Questionnaire Score
Measured: Pre-intervention
Oswestry Disability Index
Oswestry Disability Index Questionnaire Score
Measured: 6 weeks
Oswestry Disability Index
Oswestry Disability Index Questionnaire Score
Measured: 12 weeks
Numeric Pain Rating Scale
Numeric Pain Rating scale for pain
Measured: Pre-intervention
Numeric Pain Rating Scale
Numeric Pain Rating Scale for pain
Measured: 6 weeks
Numeric Pain Rating Scale
Numeric Pain Rating Scale for pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Apr 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Radiculopathy LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will be divided into two randomly assigned groups - control and experimental. Control group will receive traditional e-stim treatment with TENS plus physical therapy. Experimental group will receive direct current e-stim treatment with the Neubie device plus physical therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuFit - Neurological Fitness and Education
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramona von Leden, PhD, Study director, NeuFit - Neurological Fitness and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421558
- Sponsor's protocol ID
- Pro00077736
- Status last verified
- Jul 2024
- First submitted
- 8 Apr 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
PubMed 31788391Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.
PubMed 17445735Sharma H, Lee SW, Cole AA. The management of weakness caused by lumbar and lumbosacral nerve root compression. J Bone Joint Surg Br. 2012 Nov;94(11):1442-7. doi: 10.1302/0301-620X.94B11.29148.
PubMed 23109619Lewis R, Williams N, Matar HE, Din N, Fitzsimmons D, Phillips C, Jones M, Sutton A, Burton K, Nafees S, Hendry M, Rickard I, Chakraverty R, Wilkinson C. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. doi: 10.3310/hta15390. No abstract available.
PubMed 22078311Aono H, Iwasaki M, Ohwada T, Okuda S, Hosono N, Fuji T, Yoshikawa H. Surgical outcome of drop foot caused by degenerative lumbar diseases. Spine (Phila Pa 1976). 2007 Apr 15;32(8):E262-6. doi: 10.1097/01.brs.0000259922.82413.72.
PubMed 17426622Girardi FP, Cammisa FP Jr, Huang RC, Parvataneni HK, Tsairis P. Improvement of preoperative foot drop after lumbar surgery. J Spinal Disord Tech. 2002 Dec;15(6):490-4. doi: 10.1097/00024720-200212000-00010.
PubMed 12468976Bauer P, Krewer C, Golaszewski S, Koenig E, Muller F. Functional electrical stimulation-assisted active cycling--therapeutic effects in patients with hemiparesis from 7 days to 6 months after stroke: a randomized controlled pilot study. Arch Phys Med Rehabil. 2015 Feb;96(2):188-96. doi: 10.1016/j.apmr.2014.09.033. Epub 2014 Oct 18.
PubMed 25449195Glaser JA, Baltz MA, Nietert PJ, Bensen CV. Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain. 2001 Oct;2(5):295-300. doi: 10.1054/jpai.2001.25523.
PubMed 14622808Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.
PubMed 14622708Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8. doi: 10.1016/s1067-2516(98)80048-3.
PubMed 9798171Gilcreast DM, Stotts NA, Froelicher ES, Baker LL, Moss KM. Effect of electrical stimulation on foot skin perfusion in persons with or at risk for diabetic foot ulcers. Wound Repair Regen. 1998 Sep-Oct;6(5):434-41. doi: 10.1046/j.1524-475x.1998.60505.x.
PubMed 9844163da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.
PubMed 25665520Ordog GJ. Transcutaneous electrical nerve stimulation versus oral analgesic: a randomized double-blind controlled study in acute traumatic pain. Am J Emerg Med. 1987 Jan;5(1):6-10. doi: 10.1016/0735-6757(87)90281-6.
PubMed 3545246Zhao M, Bai H, Wang E, Forrester JV, McCaig CD. Electrical stimulation directly induces pre-angiogenic responses in vascular endothelial cells by signaling through VEGF receptors. J Cell Sci. 2004 Jan 26;117(Pt 3):397-405. doi: 10.1242/jcs.00868. Epub 2003 Dec 16.
PubMed 14679307Kanno S, Oda N, Abe M, Saito S, Hori K, Handa Y, Tabayashi K, Sato Y. Establishment of a simple and practical procedure applicable to therapeutic angiogenesis. Circulation. 1999 May 25;99(20):2682-7. doi: 10.1161/01.cir.99.20.2682.
PubMed 10338463
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy
- ClinicalTrials.gov ID
- NCT06421558
- Acronym / sponsor ID
- Pro00077736
- Keywords
- electrical stimulation, direct current, e-stim, neubie, emg
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NeuFit - Neurological Fitness and EducationIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study will be divided into two randomly assigned groups - control and experimental. Control group will receive traditional e-stim treatment with TENS plus physical therapy. Experimental group will receive direct current e-stim treatment with the Neubie device plus physical therapy.
| Arm | Type | Receives |
|---|---|---|
| Neubie Direct Current Electrical Stimulation Device | Experimental | Device: Neubie Direct Current Electrical Stimulation DeviceThe 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 | Other | Device: Transcutaneous Electrical StimulationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Currently pregnant
- Cardiac pacemaker
- Active or recent cancer
- Active or recent blood clots
- History of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neubie Direct Current Electrical Stimulation DeviceDirect Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers. | Device | Neubie Direct Current Electrical Stimulation Device |
| Transcutaneous Electrical StimulationAlso: TENSTranscutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin. | Device | Transcutaneous Electrical Stimulation |
Primary outcome
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.
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.
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.
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
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
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
Straight Leg Raise Test
Time frame: Pre-intervention
Straight Leg Raise Test degrees of movement
Straight Leg Raise Test
Time frame: 6 weeks
Straight Leg Raise Test degrees of movement
Straight Leg Raise Test
Time frame: 12 weeks
Straight Leg Raise Test degrees of movement
Oswestry Disability Index
Time frame: Pre-intervention
Oswestry Disability Index Questionnaire Score
Oswestry Disability Index
Time frame: 6 weeks
Oswestry Disability Index Questionnaire Score
Oswestry Disability Index
Time frame: 12 weeks
Oswestry Disability Index Questionnaire Score
Numeric Pain Rating Scale
Time frame: Pre-intervention
Numeric Pain Rating scale for pain
Numeric Pain Rating Scale
Time frame: 6 weeks
Numeric Pain Rating Scale for pain
Numeric Pain Rating Scale
Time frame: 12 weeks
Numeric Pain Rating Scale for pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 31788391Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
- Background: PubMed 17445735Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.
- Background: PubMed 23109619Sharma H, Lee SW, Cole AA. The management of weakness caused by lumbar and lumbosacral nerve root compression. J Bone Joint Surg Br. 2012 Nov;94(11):1442-7. doi: 10.1302/0301-620X.94B11.29148.
- Background: PubMed 22078311Lewis R, Williams N, Matar HE, Din N, Fitzsimmons D, Phillips C, Jones M, Sutton A, Burton K, Nafees S, Hendry M, Rickard I, Chakraverty R, Wilkinson C. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. doi: 10.3310/hta15390. No abstract available.
- Background: PubMed 17426622Aono H, Iwasaki M, Ohwada T, Okuda S, Hosono N, Fuji T, Yoshikawa H. Surgical outcome of drop foot caused by degenerative lumbar diseases. Spine (Phila Pa 1976). 2007 Apr 15;32(8):E262-6. doi: 10.1097/01.brs.0000259922.82413.72.
- Background: PubMed 12468976Girardi FP, Cammisa FP Jr, Huang RC, Parvataneni HK, Tsairis P. Improvement of preoperative foot drop after lumbar surgery. J Spinal Disord Tech. 2002 Dec;15(6):490-4. doi: 10.1097/00024720-200212000-00010.
- Background: PubMed 25449195Bauer P, Krewer C, Golaszewski S, Koenig E, Muller F. Functional electrical stimulation-assisted active cycling--therapeutic effects in patients with hemiparesis from 7 days to 6 months after stroke: a randomized controlled pilot study. Arch Phys Med Rehabil. 2015 Feb;96(2):188-96. doi: 10.1016/j.apmr.2014.09.033. Epub 2014 Oct 18.
- Background: PubMed 14622808Glaser JA, Baltz MA, Nietert PJ, Bensen CV. Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain. 2001 Oct;2(5):295-300. doi: 10.1054/jpai.2001.25523.
- Background: PubMed 14622708Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.
- Background: PubMed 9798171Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8. doi: 10.1016/s1067-2516(98)80048-3.
- Background: PubMed 9844163Gilcreast DM, Stotts NA, Froelicher ES, Baker LL, Moss KM. Effect of electrical stimulation on foot skin perfusion in persons with or at risk for diabetic foot ulcers. Wound Repair Regen. 1998 Sep-Oct;6(5):434-41. doi: 10.1046/j.1524-475x.1998.60505.x.
- Background: PubMed 25665520da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramona von Leden, PhD study director
NeuFit - Neurological Fitness and Education
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neubie Direct Current Electrical Stimulation Device and Transcutaneous Electrical Stimulation in people with Radiculopathy Lumbar and Radiculopathy Sacral, run by NeuFit - Neurological Fitness and Education at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Kostopoulos, MD, PhD, DPT (9175382242, dimi@handsonpt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H-Reflex (time frame: Pre-intervention). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06421558, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.