Clinical trials: Chronic Back and Leg Pain
Chronic Low Back Pain, Leg Pain
MIS MiLIF Versus Open
This study is being undertaken to compare the clinical outcomes of patients that have unilateral posterolateral lumbar interbody fusion using a traditional open approach versus the MiLIF procedure based on the MiCOR Precision…
- Trial name
- NCT00792129
- Testing
- The Atavi System
- Where
- 9 sites in United States
- Volunteers
- 113 people
- Sponsor
- Zimmer Biomet
Intractable Neuropathic Pain, Pain
Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity
The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (SCS) using the Precision device with the electrode array placed at T7 versus placement at T8.
- Conditions
- Intractable Neuropathic Pain, Pain, Back Pain, Lower Extremity Pain
- Trial name
- NCT00399841
- Testing
- Precision for Spinal Cord Stimulation
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Boston Scientific Corporation
Chronic Pain, Back Pain
Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
- Conditions
- Chronic Pain, Back Pain, Pain
- Trial name
- EVOKE (NCT02924129)
- Testing
- Evoke Spinal Cord Stimulator (SCS) System
- Where
- 16 sites in United States
- Volunteers
- 134 people
- Sponsor
- Saluda Medical Americas, Inc.
Chronic Pain
Study of PM Modulation Therapy in Trial Phase
Trialing of PM modulation therapy in patients with chronic intractable low back pain
- Trial name
- NCT03110601
- Testing
- Control - Conventional SCS, Test - Stimgenics SCS
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Stimgenics LLC
Chronic Pain, Back Pain
ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
- Conditions
- Chronic Pain, Back Pain, Pain
- Trial name
- ECAP (NCT04319887)
- Testing
- Evoke Spinal Cord Stimulation (SCS) System
- Where
- 22 sites in United States
- Volunteers
- 300 people
- Sponsor
- Saluda Medical Pty Ltd
Pain
RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Instructions for Use and…
- Trial name
- RELIEF (NCT01719055)
- Testing
- neurostimulation system
- Where
- 118 sites in United States, Argentina and 14 more
- Volunteers
- 4,800 people
- Sponsor
- Boston Scientific Corporation
Spinal; Nerve Root, Pain, Pelvic Pain
Quality of Life and Pain Changes Due to DRG Stimulation for Chronic Pain
ACTIVE study- a prospective observational clinical study examining the changes in quality of life and pain following dorsal root ganglion stimulation for the treatment of chronic intractable pelvic and lower limb pain.
- Conditions
- Spinal; Nerve Root, Pain, Pelvic Pain, Regional Pain Syndrome, Chronic Pain Syndrome
- Trial name
- ACTIVE (NCT03417973)
- Testing
- dorsal root ganglion neuromodulation
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- KM Clinical Research Group
Chronic Pain
A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes
The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.
- Trial name
- COVERAGE (NCT02384096)
- Testing
- Conventional single source programming, Precision Spectra SCS System advanced programming
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Boston Scientific Corporation
Pain, Chronic, Pain, Intractable
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety, comfort and compliance with the Nalu Neurostimulation System in adult…
- Conditions
- Pain, Chronic, Pain, Intractable, Pain, Back
- Trial name
- nPower™-US (NCT04503109)
- Testing
- Nalu Neurostimulation System
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Nalu Medical, Inc.
Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)
A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days.
- Trial name
- NCT03285113
- Testing
- GiMer Medical MN 1000 External Stimulator
- Where
- Taiwan
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- GiMer Medical
Chronic Pain, Back Pain
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.
- Trial name
- VERITAS (NCT03251937)
- Testing
- Spectra WaveWriter SCS System
- Where
- 15 sites in United States
- Volunteers
- 97 people
- Sponsor
- Boston Scientific Corporation
Complex Regional Pain Syndrome (CRPS)
TARGET Post-Approval Study
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation.
- Trial name
- TARGET PAS (NCT02800863)
- Testing
- Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System), Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
- Where
- 44 sites in United States
- Volunteers
- 426 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
CoverEdge Algorithm Programming Study
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System…
- Trial name
- NCT02492880
- Testing
- Precision Spectra™ SCS system programming features
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline
- Conditions
- Lumbosacral Radicular Pain, Sciatic Radiculopathy, Sciatic Leg Pain, Sciatica
- Trial name
- NCT07264270
- Testing
- C-1101
- Where
- 6 sites in United States, Australia
- Volunteers
- 24 people
- Sponsor
- Consano Bio
Pain, Chronic, Pain, Back
Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain
This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in patients with chronic back pain or lower limb pain.
- Conditions
- Pain, Chronic, Pain, Back, Pain, Radiating
- Trial name
- NCT03543085
- Testing
- GiMer Medical MN 1000 External Stimulator
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- GiMer Medical
Failed Back Surgery Syndrome, Post-Laminectomy Syndrome
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.
- Conditions
- Failed Back Surgery Syndrome, Post-Laminectomy Syndrome, Low Back Pain
- Trial name
- SENSE (NCT01990287)
- Testing
- SCS and PNfS, SCS Alone
- Where
- 28 sites in United States
- Volunteers
- 38 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial
This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation…
- Trial name
- NCT02988713
- Testing
- Programming
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Boston Scientific Corporation