Clinical trials: Spine Pain
Acute Low-back Pain, Chronic Low-back Pain
Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain
Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control
- Conditions
- Acute Low-back Pain, Chronic Low-back Pain, Pain, Intractable
- Trial name
- NCT04494698
- Testing
- Duotherm VibraCool Back Device, TENS 8-channel unit
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- MMJ Labs LLC
Spinal Fractures, Fractures, Compression
The Kiva® System as a Vertebral Augmentation Treatment
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or…
- Conditions
- Spinal Fractures, Fractures, Compression, Back Injuries
- Trial name
- KAST (NCT01123512)
- Testing
- Vertebral augmentation
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Benvenue Medical, Inc.
Spine Injuries and Disorders, Pain, Chronic
Real-Time Accurate Pathology Inspection and Decompression Study
The primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (LAND) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain.
- Conditions
- Spine Injuries and Disorders, Pain, Chronic, Pain, Back, Pain, Neck
- Trial name
- RAPID (NCT05347108)
- Testing
- laser-assisted neural decompression (LAND) procedure
- Where
- United States
- Sponsor
- KM Clinical Research Group
Facet Syndrome of Lumbar Spine
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain
- Trial name
- NCT04129034
- Testing
- Neurolyser XR
- Where
- 5 sites in Canada
- Volunteers
- 30 people
- Sponsor
- FUSMobile Inc.
Pain, Postoperative
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe…
- Trial name
- NCT00779038
- Testing
- Fentanyl ITS
- Where
- 3 sites in Belgium
- Volunteers
- 13 people
- Sponsor
- Janssen Cilag N.V./S.A.
Osteoarthritis, Spine
Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis
Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine.
- Trial name
- NCT04841512
- Testing
- XT-150
- Where
- Australia
- Sponsor
- Xalud Therapeutics, Inc.
Facet Syndrome of Lumbar Spine
Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain
- Trial name
- NCT05154448
- Testing
- Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)
- Where
- 10 sites in United States
- Volunteers
- 90 people
- Sponsor
- FUSMobile Inc.
Chronic Back Pain
SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
- Trial name
- NOVA (NCT04571242)
- Testing
- DTM Programming, Conventional SCS programming
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- SGX Nova LLC
Intervertebral Disc Displacement, Intervertebral Disc Degeneration
Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine
NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy, and of the adjacent degenerated disc, if…
- Trial name
- NDisc (NCT01640457)
- Testing
- NOVOCART® Disc plus, NOVOCART® Disc basic
- Where
- 10 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Tetec AG
Osteoarthritis of the Lumbar Spine, Pain, Back
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis of the Lumbar Spine
This is a Phase 3, Multicenter, Randomized, 22 Week, Double-Blind, Placebo Controlled and 3-Week, Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of Subjects with…
- Trial name
- NCT03110523
- Testing
- X0002
- Sponsor
- Techfields Pharma Co. Ltd
Lumbar Spine Stenosis, Lumbar Spine Degeneration
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research.
- Trial name
- NCT05452694
- Where
- 3 sites in United States
- Volunteers
- 235 people
- Sponsor
- OpalGenix, Inc
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
Degenerative Spondylolisthesis
Safety Evaluation of ART352-L in Subjects Undergoing Posterolateral Spinal Fusion
Ankasa Regenerative Therapeutics, Inc. (Ankasa) is developing ART352-L, a liposomal formulation of recombinant human Wnt3A protein, that is applied ex vivo, to harvested autologous bone grafts (autograft) to enhance the…
- Trial name
- NCT04378543
- Testing
- ART352-L
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Ankasa Regenerative Therapeutics, Inc.
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
Symptomatic Cervical Disc Disease
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease…
- Trial name
- SMART (NCT04012996)
- Testing
- prodisc C SK and/or Vivo, Mobi-C Cervical Disc
- Where
- 30 sites in United States
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Centinel Spine
Lumbar Radiculopathy, Lumbar Disc Herniation
Randomized Evaluation of Lumbar Injection Effectiveness and Function
The goal of this clinical trial is to learn whether the Triojection® System is safe and effective for treating symptomatic lumbar radiculopathy (leg pain caused by nerve irritation or compression) resulting from a contained…
- Conditions
- Lumbar Radiculopathy, Lumbar Disc Herniation, Contained Herniated Lumbar Disc
- Trial name
- RELIEF (NCT07856810)
- Testing
- Triojection® System, Selective Nerve Root Block (SNRB)
- Volunteers
- 300 people
- Sponsor
- SpinaFX Medical Inc.
Osteoarthritis, Pain
Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine
The primary objective of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine.
- Trial name
- NCT00426647
- Testing
- Buprenorphine, Tramadol
- Where
- Finland
- Volunteers
- 120 people
- Sponsor
- Norpharma A/S
Spondyloarthritis
SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis
The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue, and predictability of disease…
- Trial name
- SKIPPAIN (NCT03136861)
- Testing
- AIN457
- Where
- 66 sites in Belgium, Bulgaria and 15 more
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Lesions in Vertebral Bodies
Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors
To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.
- Trial name
- EU-STAR (NCT02081053)
- Testing
- STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- DFINE Inc.
Multiple Myeloma, Compression Fracture of Vertebral Column
Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple Myeloma
The objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.
- Trial name
- MM (NCT01410929)
- Testing
- Kyphoplasty/Vertebral Augmentation (Device-StabiliT)
- Sponsor
- DFINE Inc.