Clinical Trial Search

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…

Primary: Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires — 3.4; 65.2 points on a…

Primary: Oswestry Disability Index — 41.3; 30.4; 19.4 score on a scale

Primary: Neck Disability Index — 17.9; 16.7 units on a scale from 0 to 100 — p=0.641

Primary: Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use.

Primary: Oswestry Disability Index (ODI) — 43.6; 45.46; 31.31; 31.19 units on a scale

Primary: Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups — 15; 5 Participants — p=0.036

Primary: Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software. — 14.73 cm

Primary: Swiss Spinal Stenosis (SSS) Questionnaire Score — -2.0; -1.7; -4.1 units on a scale — p=0.73

Primary: Radiographic Fusion — 66; 46; 37; 75 percentage of subjects

Primary: Number of Subjects With Successful Radiographic Fusion — 90 Participants

Primary: Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase — 32.3; 32.6; 12.8; 21.2 score on a scale

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

Primary: Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. — 35 participants with > 50% VAS improvement

Primary: Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis — 23.19; 26.08 change of…

Primary: Muscle Weakness — 2; 3 Participants

Primary: Composite Definition of Study Success — 65.3; 73.7; 37.4; 69.7 percentage of subjects analyzed — p=0.0021

Primary: Walking Speed Change From Baseline — .054; .078; .085; .039 meters/second

Primary: Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain — 60; 72 percentage of participants — p=0.23

Primary: Fusion Rates Per Level Using the Bridwell Interbody Grading Scale — 64; 50 Fusions

Primary: Pain Assessed by Visual Analogue Scale — 5.63; 5.92 units on a scale

Primary: Change in Low Back Pain — 2.58; 1.80 units on a scale

Primary: The Difference in Responders Between Both Groups — 87; 5 participants — p=<0.0001

Primary: Overall Success at 24 Months Relative to Baseline — 42.2; 28.3; 61.9; 52.8 percentage of participants — p=<0.05

Primary: Overall Success — 71 Participants

Primary: Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail) — 17 Events

Primary: Virtual Environment TBI System (VETS) Assessment of Static Posturography — 11; 13.0; 48.4; 19.1 Square Centimeters

Primary: Pain Diary — 6.71; 5 units on a scale

Primary: Neurological Assessment for Motor Function and Reflexes/Sensory — 0; 0 participants

Primary: Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data — 6104.45; 6355.3 grams — p=.318