Clinical trials: Chronic Back and Leg Pain
Back Pain, Chronic Pain
Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode
The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode in patients with Failed Back…
- Conditions
- Back Pain, Chronic Pain, Pain in Leg, Unspecified
- Trial name
- NCT00386724
- Testing
- Precision Spinal Cord Stimulation System, Artisan Surgical Lead
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Boston Scientific Corporation
Chronic Low Back Pain, Hip Ostearthritis
Making Better Lives: Patient-Focused Care for Low Back Pain (LBP)
Back pain is a huge problem for millions of Americans, including nearly 11 million Veterans. Our older Veterans suffer the most. Citizens spend billions of dollars, yet consistently get poor results.
- Conditions
- Chronic Low Back Pain, Hip Ostearthritis, Myofascial Pain Syndrome, Fibromyalgia
- Trial name
- NCT02697435
- Testing
- Patient-Centered Care, Imaging-Directed Care
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- VA Office of Research and Development
Chronic Neuropathic Pain in the Low Back and Legs
Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain
- Trial name
- NCT02916498
- Testing
- Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Boston Scientific Corporation
Chronic Lower Limb Pain
A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral…
- Trial name
- ACCURATE (NCT01923285)
- Testing
- AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
- Where
- 22 sites in United States
- Volunteers
- 152 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal…
- Trial name
- SOLIS (NCT04676022)
- Testing
- WaveWriter, Conventional Medical Managament
- Where
- 23 sites in United States
- Volunteers
- 241 people
- Sponsor
- Boston Scientific Corporation
Chronic Non-malignant Pain, Chronic Pain
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of…
- Conditions
- Chronic Non-malignant Pain, Chronic Pain, Pain, Back, Pain, Leg
- Trial name
- NCT03761277
- Testing
- Medtronic SynchroMed™ II infusion system, Preservative-free morphine sulfate (PFMS)
- Where
- 16 sites in United States
- Volunteers
- 93 people
- Sponsor
- MedtronicNeuro
Low Back Pain
Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients
The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back…
- Trial name
- NCT00290238
- Testing
- Vertis Percutaneous Neuromodulation Therapy (PNT), Transcutaneous Electrical Nerve Stimulation (TENS)
- Where
- 8 sites in United States
- Volunteers
- 122 people
- Sponsor
- RS Medical
Low-Back Pain
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care…
- Trial name
- PRO (NCT02273908)
- Testing
- No intervention
- Where
- 33 sites in Japan
- Volunteers
- 331 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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
Low Back Pain, Sciatica
Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain
Guidelines advocate several complementary modalities as alternatives to drugs and other invasive treatments for chronic low back pain (LBP) conditions.
- Conditions
- Low Back Pain, Sciatica, Back Related Leg Pain, Pain, Chronic
- Trial name
- SUPPORT (NCT05022121)
- Testing
- Supported Biopsychosocial Self-Management (SBSM), Medical Care
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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
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
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