Clinical trials: Chronic Leg Pain
Pain, Chronic, Pain, Radiating
Change in Pain and Quality of Life Following SCS for Chronic Pain
Study Title Subject-reported treatment efficacy and procedure satisfaction (steps) study.BURST study- a prospective observational clinical study examining the changes in quality of life and pain following spinal cord stimulation…
- Conditions
- Pain, Chronic, Pain, Radiating, Pain, Back, Pain Syndrome
- Trial name
- BURST (NCT03421951)
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- KM Clinical Research Group
Chronic Pain
Algovita Spinal Cord Stimulation System Hi-Fi Study
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high…
- Trial name
- NCT03622866
- Testing
- Ultra-high pulse width stimulation, Traditional pulse width stimulation
- Where
- 10 sites in United States
- Volunteers
- 20 people
- Sponsor
- Nuvectra
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
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
Peripheral Vascular Diseases
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
- Trial name
- PROOF (NCT00504088)
- Testing
- Bypass, Silverhawk Plaque Excision
- Where
- 31 sites in United States
- Sponsor
- FoxHollow Technologies
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, Intractable Pain
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).
- Conditions
- Chronic Pain, Intractable Pain, Low Back Pain, Chronic Low-back Pain
- Trial name
- MOSAIC (NCT07190807)
- Testing
- Boston Scientific WaveWriter Alpha™ SCS Systems
- Where
- 7 sites in United States
- Volunteers
- 70 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 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
Critical Limb Ischemia
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
- Trial name
- NCT01064440
- Testing
- Low Dose VM202, High Dose VM202
- Where
- 16 sites in United States, South Korea
- Volunteers
- 52 people
- Sponsor
- Helixmith Co., Ltd.
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 Low Back and Leg Pain
Spinal Cord Stimulation Research Study
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.
- Trial name
- ADR-SCS (NCT00768872)
- Where
- 3 sites in United States
- Volunteers
- 66 people
- Sponsor
- MedtronicNeuro
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.
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
Hip Arthritis, Hip Disease
MDR - PMCF Study for Taperloc Complete Stems
The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at…
- Conditions
- Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries
- Trial name
- NCT04028687
- Testing
- Taperloc Complete Stem
- Where
- 3 sites in United States
- Volunteers
- 820 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Chronic Low-back Pain
Safety Study for An Artificial Disc Nucleus Replacement to Treat Chronic Low Back Pain
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
- Trial name
- NCT04004156
- Testing
- PerQdisc® Nucleus Replacement Device.
- Where
- 4 sites in Belgium, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- Spinal Stabilization Technologies
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
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
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 Low Back Pain, Pain in Leg, Unspecified
Clinical Outcomes of the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain
This study evaluates the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain. Patients who have been diagnosed with failed back surgery syndrome (FBSS) will receive a stimulator device for…
- Trial name
- NCT02403518
- Testing
- Freedom Spinal Cord Stimulator System
- Where
- Netherlands
- Volunteers
- 45 people
- Sponsor
- Curonix LLC