Clinical Trial Search

Primary: The Change in Modified Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline — -4.3; -3.0 score on a scale

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

Primary: Time to First Symptoms of Moderate Pain — 2.52; 3.06 minutes

Primary: Roland Morris — 11.8; 12.5 units on a scale

Primary: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.3 units 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 ODI From Baseline to 24 Months — -19.0; -22.5 percentage points

Primary: Utilization of ESI — 3.6; 3.3 number of ESI between 18-24 months

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…

Primary: Mean Change in VAS — 2.52; 0.06 units on a scale — p=<0.05

Primary: Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months — 83; 35 Participants

Primary: Visual Analog Scale (VAS) <=4 — 11; 2 participants

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…

Primary: Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.59 units on a scale — p=<0.0001

Primary: Pain as Measured by Visual Analog Scale (VAS). — 2.17 units on a scale — p=<0.0001

Primary: Percentage of Subjects With Clinically Significant Improvement in Outcomes — 56.3; 56.0 percentage of subjects

Primary: Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad) — 58.7; 67.7; 13.6; 59.7 units on a scale

Primary: Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). — 3.21 units on a scale — p=<0.0001

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

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…

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

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: Clinical Pain Severity - 50% Reduction Responders vs Nonresponders — -83; 0 percentage of change

Primary: Number of Subjects With Improvement of at Least 15 Points in ODI — 41; 101 Participants

Primary: Numerical Rating Leg Pain Score — 2.54; 3.56; 3.78 units on a scale

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

Primary: Percentage of Participants With a 2-point Improvement in Visual Analogue Scale — 65.71; 46.15 percentage of responders

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: Treatment Success Rates (At ≥ 5 Years) — 40.8; 30.8; 38.7; 53.8 percentage of participants

Primary: Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable — 7.1; 5.8 units on a scale