Clinical trials: Chronic Leg Pain
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, 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
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
Renal Pelvis Cancer, Restless Legs Syndrome
Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)
High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in the Adverse Events…
- Conditions
- Renal Pelvis Cancer, Restless Legs Syndrome, Epilepsy, Neuropathic Pain
- Trial name
- NCT01138124
- Testing
- Gabapentin prescriptions
- Volunteers
- 54,202 people
- Sponsor
- GlaxoSmithKline
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, 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 with the Nalu Neurostimulation System in adult subjects with chronic pain in…
- 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.
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
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
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
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
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.
Chronic Lower Limb Pain
Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
The objectives of this non-significant risk (NSR) study are to evaluate the safety of the short term placement of the Basmati Injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate…
- Trial name
- BASMATI (NCT04672096)
- Testing
- Neuronoff BASMATI Injectrode
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Neuronoff, Inc
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 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
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 Low Back Pain, Chronic Leg Pain
Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
A BIOTRONIK wearable stimulator will be utilized in order to investigate the effects of two study spinal cord stimulation (SCS) therapies on subject reported pain and paresthesia perception observed over 12 days of study…
- Trial name
- NCT03594266
- Testing
- Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components, Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components
- Where
- 18 sites in United States
- Volunteers
- 136 people
- Sponsor
- Biotronik, Inc.
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
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
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
Leg Ulcers
Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers
The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.
- Trial name
- NCT00627094
- Testing
- Biatain, Biatain Ibu
- Where
- 13 sites in Denmark, France and 2 more
- Volunteers
- 120 people
- Sponsor
- Coloplast A/S