Clinical Trial Search

Primary: Numeric Pain Rating Scale (NPRS) — 14; 3 Participants

Primary: Average Numeric Rating Scale — 8.2; 7.9; 3.8; 3.5 units on a scale — p=>0.05

Primary: Facet Joint High Grade FDG Activity Concordance to Pain — 0.10 concordance correlation coefficient

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

Primary: Cost Per Successful Procedure — 15,241; 17,142; 6286 U.S. dollars

Primary: Pain Intensity — 4.2; 4.1; 4.0 score on a scale

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

Primary: Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs — 11; 12; 14; 14 Participants

Primary: Low Back Pain After 6 Weeks of Intervention — 6.50; 6.00; 1.50; 3.50 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: Safety of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA) — 0; 0 Participants

Primary: Participant-reported "Flares" of Low Back Pain (Aim 1) — 7.3 Mean flares per year

Primary: Change From Baseline in Oswestry Disability Scale (0-100%) — -8.26; -7.75; -8.00; -9.48 units on a scale

Primary: Measure of Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Physical Function Score — 1.7; 1.6; 1.7 score on a scale

Primary: Numeric Rating Scale (NRS) — 8.2; 8.2; 3.5; 3.2 units on a scale — p=<0.05

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: Percentage of Patients With Magnetic Resonance Imaging (MRI) Evidence of Tissue Ablation/Edema at Targeted Lumbar Medial Branches — 100 percentage of participants

Primary: Leg Length Inequality — 0.3; 0.58 centemeter

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: Number of Subjects With Successful Radiographic Fusion — 90 Participants

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

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

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

Primary: Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%) — -11.06; -9.10 units on a scale — p=<.0001

Primary: Numeric Pain Rating Score — 7.9; 8.1; 4.9; 3.4 units on a scale — p=<0.001

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: Number of Procedures in Which Temperature of Screws Increased — 4; 2 procedures

Primary: Change in ODI From Baseline to 24 Months — -19.0; -22.5 percentage points

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

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