Clinical trials: Lower Extremity Pain
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.
Lumbar Spinal Stenosis
Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System
The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal…
- Trial name
- NCT00529997
- Testing
- Stabilimax NZ® Dynamic Spine Stabilization System
- Where
- 19 sites in United States
- Volunteers
- 480 people
- Sponsor
- Applied Spine Technologies
Osteoarthritis of the Knee, Degenerative Osteoarthritis
Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis
The primary research purpose is to determine if the use of a drug therapy intervention (each study participant will be randomly assigned to receive one of 3 study medications which will be blinded from everyone, including the…
- Conditions
- Osteoarthritis of the Knee, Degenerative Osteoarthritis, Knee Pain Chronic
- Trial name
- PRPNSAIDsKOA (NCT05742763)
- Testing
- Ibuprofen and PRP, Acetaminophen and PRP
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QC Kinetix LLC
Peripheral Arterial Disease, Atherosclerotic Lesion
Study of the R3 Vascular Drug-Eluting Bioresorbable Scaffold in Treating Below the Knee Arterial Disease
This first-in-human clinical feasibility study will evaluate the safety and performance of the R3 Vascular MAGNITUDE® Bioresorbable Drug-Eluting Scaffold and Delivery System in patients undergoing treatment for peripheral…
- Conditions
- Peripheral Arterial Disease, Atherosclerotic Lesion, Lower Extremity Ischemia, Lower Extremity Claudication
- Trial name
- RESOLV I (NCT04912323)
- Testing
- Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold
- Where
- 7 sites in Austria, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- R3 Vascular Inc.
Ankle Sprain
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.
- Trial name
- NCT00446797
- Testing
- Non-selective NSAIDS, Celecoxib
- Where
- 16 sites in Brazil, Costa Rica and 6 more
- Volunteers
- 278 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris 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
Knee Pain Chronic, Knee Injuries
Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%
Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders.
- Trial name
- NCT02068859
- Testing
- Diclofenac Cream 8%, Diclofenac Gel 1%
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- FPR Specialty Pharmacy
Intermittent Claudication, Peripheral Vascular Disease
Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication
The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a…
- Conditions
- Intermittent Claudication, Peripheral Vascular Disease, Atherosclerosis
- Trial name
- WALK (NCT00117650)
- Testing
- Ad2/HIF-1α/VP16
- Where
- 47 sites in United States, Germany and 1 more
- Volunteers
- 289 people
- Sponsor
- Genzyme, a Sanofi Company
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
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
Lumbosacral Radicular Pain
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.
- Trial name
- NCT03613662
- Testing
- SP-102
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Semnur Pharmaceuticals, Inc.
Medial Malleolus Fracture, Lisfranc Injury
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations…
- Conditions
- Medial Malleolus Fracture, Lisfranc Injury, Lisfranc Fracture, Talus Fracture
- Trial name
- NCT05555459
- Testing
- Operation
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Inion Oy
Lower Limb Spasticity
RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity.
- Trial name
- RELIEF (NCT02020980)
- Testing
- Botulinum toxin type A
- Where
- 28 sites in Spain
- Volunteers
- 186 people
- Sponsor
- Ipsen
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
Pain, Back Pain
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.
- Conditions
- Pain, Back Pain, Low Back Pain, Back Pain With Radiation
- Trial name
- NCT00986180
- Testing
- NUCYNTA, Oxycodone IR
- Where
- 74 sites in United States
- Volunteers
- 667 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics
Peripheral Arterial Disease
Evaluation of the GORE TIGRIS Vascular Stent
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial…
- Trial name
- TIGRIS (NCT01576055)
- Testing
- TIGRIS Vascular Stent, BARD LifeStent
- Where
- 34 sites in United States
- Volunteers
- 267 people
- Sponsor
- W.L.Gore & Associates
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
Hip Disease, Hip Fractures
MDR - M/L Taper With Kinectiv Technology Stems and Necks
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip…
- Conditions
- Hip Disease, Hip Fractures, Hip Injuries, Hip Arthritis
- Trial name
- NCT04027140
- Testing
- M/L Taper with Kinectiv Technology Stems and Necks
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Zimmer Biomet