Phase 4 N=29 Lumbar Stenosis Outcomes Research (LUSTOR)
Lumbar Spinal Stenosis
Primary: Time to First Symptoms of Moderate Pain — 2.52; 3.06 minutes
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=162 Intermittent Neurogenic Claudication Treatment With APERIUS®
Spinal Stenosis
Primary: Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity — -29.7…
N/A N=196 Efficacy of Acupuncture for Lumbar Spinal Stenosis
Lumbar Spinal Stenosis · Intermittent Claudication
Primary: The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline — -4.3; -3.0 score on a scale
Phase 4 N=163 Neurogenic Intermittent Claudication Evaluation Study
Spinal Stenosis
Primary: Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire — -32.31; -37.48 percentage…
N/A N=239 Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
Spinal Stenosis
Primary: Change in ODI From Baseline to 24 Months — -19.0; -22.5 percentage points
N/A N=259 Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
Lumbar Spinal Stenosis
Primary: Swiss Spinal Stenosis (SSS) Questionnaire Score — -2.0; -1.7; -4.1 units on a scale — p=0.73
N/A N=302 The MiDAS ENCORE Study
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Primary: Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months — 83; 35 Participants
N/A N=21 Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication
Intermittent Claudication · Peripheral Vascular Disease
Primary: Change From Baseline in Initial Walking Distance — 64.3 metres
N/A N=92 Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk
Herniated Lumbar Disc
Primary: Pain Assessed by Visual Analogue Scale — 5.63; 5.92 units on a scale
Phase 2 N=149 Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Lumbosacral Radiculopathy
Primary: Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale…
N/A N=168 The STEPS - Totalis™ Trial
Lumbar Spinal Stenosis
Primary: Percentage of Subjects With Clinically Significant Improvement in Outcomes — 56.3; 56.0 percentage of subjects
N/A N=10 The Vertos MILD™ Preliminary Patient Evaluation Study
Lumbar Spinal Stenosis
Primary: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.3 units on a scale
Phase 4 N=400 Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
Spinal Stenosis · Low Back Pain
Primary: Roland Morris — 11.8; 12.5 units on a scale
Phase 3 N=401 Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Lumbosacral Radicular Pain
Primary: Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg — -2.34; -1.16 Change in score on a scale…
N/A N=40 Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
Lumbar Spine Stenosis Central Canal
Primary: Visual Analog Scale (VAS) <=4 — 11; 2 participants
N/A N=59 Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease · Lumbar Spondylosis · Low Back Pain
Primary: Pain Diary — 6.71; 5 units on a scale
N/A N=120 Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
Low Back Pain
Primary: Numeric Pain Rating Score — 7.9; 8.1; 4.9; 3.4 units on a scale — p=<0.001
Phase 4 N=13 Milnacipran for Lumbosacral Radicular Pain
Radicular Pain Related to Lumbosacral Disc Disease
Primary: Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad) — 58.7; 67.7; 13.6; 59.7 units on a scale
N/A N=100 Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
Lumbar Spinal Stenosis · Spondylolisthesis
Primary: Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning — 47; 22; 6 Surgical plans
N/A N=165 Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis
Lumbar Spinal Stenosis
Primary: Utilization of ESI — 3.6; 3.3 number of ESI between 18-24 months
Phase 4 N=146 Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
Sciatica · Back Pain
Primary: To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and…
N/A N=138 MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Lumbar Spinal Stenosis
Primary: Percentage of Participants With a 2-point Improvement in Visual Analogue Scale — 65.71; 46.15 percentage of responders
Phase 4 N=38 Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis
Lumbar Spinal Stenosis
Primary: Mean Change in VAS — 2.52; 0.06 units on a scale — p=<0.05
N/A N=322 Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Spinal Stenosis
Primary: Number of Subjects With Improvement of at Least 15 Points in ODI — 41; 101 Participants
N/A N=575 LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
Degenerative Disc Disease
Primary: Composite Definition of Study Success — 65.3; 73.7; 37.4; 69.7 percentage of subjects analyzed — p=0.0021
N/A N=30 Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain
Low Back Pain
Primary: Tolerability of Electrical Stimulation (NMES) — 0; 5; 8; 0 Participants
N/A N=158 Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
Chronic Pain
Primary: Clinical Pain Severity - 50% Reduction Responders vs Nonresponders — -83; 0 percentage of change
N/A N=75 Gait in Low Back Pain Patients After Spinal Mobilization
Chronic Low Back Pain
Primary: Change in the Numerical Pain Rating Scale — 5.96; 6.12; 6; 1.22 units on a scale
Phase 4 N=55 MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Lumbar Spinal Stenosis
Primary: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.59 units on a scale — p=<0.0001
Phase 3 N=84 A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Primary: Numerical Rating Leg Pain Score — 2.54; 3.56; 3.78 units on a scale