Clinical trials: Lumbar
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
Postdural Puncture Headache, Post-Lumbar Puncture Headache
Incidence of Headache Following an Unintentional Dural Puncture
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (PDPH) in obstetric patients.
- Conditions
- Postdural Puncture Headache, Post-Lumbar Puncture Headache, Cerebrospinal Fluid Leaks
- Trial name
- NCT01977898
- Testing
- Morphine, Saline
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Lumbar Facet Syndrome
A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome
Chronic, non-neurogenic low back pain (CLBP) is a common condition that affects many individuals across their lives. The lumbar facet joint has been implicated as an important source of CLBP, with a prevalence of 15-45%.
- Trial name
- NCT03614793
- Testing
- Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Utah
Postoperative Pain Management
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL…
- Trial name
- FUSION (NCT03927911)
- Testing
- EXPAREL and Bupivacaine, Standard of Care
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Pacira Pharmaceuticals, 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
Hip Arthroplasty
Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.
- Trial name
- NCT00934661
- Testing
- Extended Release Epidural Morphine (EREM)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University
Degenerative Disc Disease, Lumbar Spondylosis
Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
The main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease.
- Conditions
- Degenerative Disc Disease, Lumbar Spondylosis, Low Back Pain
- Trial name
- NCT03484403
- Testing
- Lumbar back brace, Back school
- Volunteers
- 61 people
- Sponsor
- Dallas VA Medical Center
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
Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
- Trial name
- NCT01110967
- Where
- 3 sites in Czechia, Slovakia and 1 more
- Volunteers
- 40 people
- Sponsor
- Medtronic Spinal and Biologics
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
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
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.
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
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
Degenerative Disc Disease
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in…
- Trial name
- MSB-DR003 (NCT02412735)
- Testing
- Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture
- Where
- 48 sites in United States, Australia
- Volunteers
- 404 people
- Sponsor
- Mesoblast, Ltd.
Surgical Sponge, Retained
Intraoperative Radiographic Detection of Retained Surgical Sponges
This prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. The recommended practice for finding a retained sponge is by radiography.
- Trial name
- NCT04097678
- Testing
- Retained Surgical Sponge
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Twin Cities Spine Center
Lumbar Spinal Stenosis
A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis
The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis.
- Trial name
- NCT00401518
- Testing
- Non-randomized ACADIA® Facet Replacement System, Randomized ACADIA® Facet Replacement System, Randomized Instrumented posterolateral fusion (PLF)
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Globus Medical Inc
Spinal Injuries, Adhesions
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group…
- Trial name
- NCT00387829
- Testing
- DuraGen Plus Adhesion Barrier Matrix
- Where
- 36 sites in United States
- Volunteers
- 347 people
- Sponsor
- Integra LifeSciences Corporation
Postmenopausal Osteoporosis
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women.
- Trial name
- NCT00545051
- Testing
- ibandronate
- Where
- 15 sites in Finland
- Volunteers
- 140 people
- Sponsor
- Hoffmann-La Roche
Post Menopausal Osteoporosis
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration.
- Trial name
- NCT00048074
- Testing
- ibandronate [Bonviva/Boniva]
- Where
- 64 sites in United States, Australia and 14 more
- Volunteers
- 1,395 people
- Sponsor
- Hoffmann-La Roche