Clinical trials: Lumbar Spine Pathology
Degenerative Changes, Stenosis
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT02018445
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- SeaSpine, Inc.
Degenerative Changes, Stenosis
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared…
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT01873586
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- SeaSpine, Inc.
Low Back Pain, Opiate Addiction
Study of Opioid Use After Lumbar and Cervical Spine Surgery
The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery.
- Conditions
- Low Back Pain, Opiate Addiction, Neck Pain
- Trial name
- SOULCS (NCT02674711)
- Testing
- Educational Video
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Brooke Army Medical Center
Chronic Low-back Pain, Postsurgical Pain
Postoperative Telehealth Mindfulness Intervention After Spine Surgery
Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States.
- Conditions
- Chronic Low-back Pain, Postsurgical Pain, Opioid Use, Lumbar Spine Surgery
- Trial name
- NCT04648683
- Testing
- Individual telehealth mindfulness, Group telehealth mindfulness
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vanderbilt University Medical Center
Back Pain, Radiculopathy Lumbar
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery.
- Conditions
- Back Pain, Radiculopathy Lumbar, Degenerative Lumbar Spinal Stenosis
- Trial name
- NCT03801356
- Testing
- Selective Nerve Root Block
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- The Cleveland Clinic
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Low Back Pain, Lumbosacral Radiculopathy
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of…
- Conditions
- Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation
- Trial name
- NCT03514277
- Testing
- Exparel, Bupivacaine
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Lumbar Spine Disc Herniation, Lumbar Radiculitis
Dexamethasone Versus Depo Medrol in Lumbar Epidurals
Comparison of Dexamethasone versus Depo Medrol when used in lumbar epidural injections will be conducted on subjects that have not had previous injections or have not had an injection in the last 12 months.
- Conditions
- Lumbar Spine Disc Herniation, Lumbar Radiculitis, Lumbar Back Pain
- Trial name
- NCT01397552
- Testing
- Dexamethasone, methylprednisolone acetate
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- State University of New York - Upstate Medical University
Pain, Opioid Use
Comparison of Quadratus Lumborum Block Types
This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain…
- Conditions
- Pain, Opioid Use, Lumbar Disc Herniation
- Trial name
- NCT04588389
- Testing
- Ropivacaine injection Location 1, Ropivacaine injection Location 2, Multimodal Pharmacological Management
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Massachusetts, Worcester
Lumbar Spinal Stenosis
Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer
The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one…
- Trial name
- NCT01156675
- Testing
- FLEXUS(TM) Interspinous Spacer, XSTOP® Interspinous Spacer
- Where
- United States
- Volunteers
- 215 people
- Sponsor
- Globus Medical Inc
Radiculopathy, Herniated Disk
Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy
Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by disc herniation. Among the various surgical techniques practiced the percutaneous discectomy occupies its space since the first…
- Trial name
- PDOP_TLR (NCT01367860)
- Testing
- Open microdiscectomy, Percutaneous Diskectomy SpineJet
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Chronic Pain
Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
The purpose of this study is to learn whether or not certain risk factors and patient characteristics are linked with and possibly can predict the development of chronic pain after lumbar spine surgery.
- Trial name
- NCT03444168
- Where
- United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Pain, Intractable, Pain, Chronic
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic…
- Trial name
- NCT06442410
- Testing
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Conventional Medical Management (CMM)
- Where
- 12 sites in Belgium, Germany and 2 more
- Volunteers
- 115 people
- Sponsor
- MedtronicNeuro
Opioid Dependence, Chronic Pain
Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in…
- Trial name
- NCT04220489
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Jacques E. Chelly
Surgical Blood Loss, Spinal Surgery
Efficacy of Suction Enabled Retraction Device
This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue Elevator \& Retractor [SISTER] device to assess: Effects on operative time and efficiency of exposure in open lumbar spine cases.
- Trial name
- NCT03160170
- Testing
- SISTER device
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Miami
Low Back Pain
FDG PET/MRI Evaluation of Facet Joint Pain
Chronic pain incurs over half a trillion dollars in lost productivity (healthcare, lost wages, etc) annually. The most common source is low back pain (LBP), often from facet joints.
- Trial name
- NCT02921490
- Testing
- FDG PET/MR examination.
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Lumbar Spine Surgery, Chronic Low-back Pain
Telehealth Mindfulness After Spine Surgery
The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions: 1.
- Conditions
- Lumbar Spine Surgery, Chronic Low-back Pain, Postsurgical Pain
- Trial name
- NCT05698914
- Testing
- Telehealth mindfulness-based intervention (MBI), Telehealth Education
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Vanderbilt University Medical Center
Fusion of Spine, Lumbar Region
The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion
Simple explanation and rationale: Recovery after spine surgery is usually accompanied by severe pain which has traditionally been managed with opioids.
- Trial name
- NCT03104816
- Testing
- Acetaminophen IV Soln 10 MG/ML, Acetaminophen, Hydromorphone
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Lumbar Degenerative Disc Disease, Spinal Stenosis
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.
- Conditions
- Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- NCT02070484
- Testing
- NuCel, Demineralized Bone Matrix
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- OhioHealth