Clinical Trial Search

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

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

Primary: Muscle Weakness — 2; 3 Participants

Primary: Comparing Visual Analogue Scale (VAS) — 9.3; 8.6; 5.7; 4.9 score on a scale — p=0.112

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

Primary: Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) — 3.67; 3.33; 3.67; 3.33 score on a scale — p=0.2375

Primary: Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. — 25; 121 cmH2O — p=<0.05

Primary: Change in Walking Function - 10m Walk Walking Speed (m/s) — 0.06; 0.16 speed difference in meters per second

Primary: Change in Exercise Pressor Reflex From Baseline — 8.67; 16.29 mmHG

Primary: Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire — -3.7 units on a scale — p=<0.01

Primary: Percent Change MSNA Burst Frequency From Baseline to 60 Minutes — -29; -24 Percent change MSNA burst frequency

Primary: Stimulation Thresholds to a Variety of Stimulus Parameters — 2.13 milliamps

Primary: Change in Back Pain Intensity — 20.9; 25.6 Percent Change From Baseline — p=0.74

Primary: Responder Rate — 51; 5 Participants

Primary: Electromyography Response Amplitude — 33.7; 122.1; 39.2; 69.7 microvolts (mV) — p=<0.01

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

Primary: Change in Visual Analog Score From Baseline to Day 14 — -5.1 score on a scale

Primary: Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity — 58 Participants

Primary: Cerebral Blood Flow and VAS With Optimal Paresthesia Coverage Compared With SCS Off

Primary: Montgomery Asberg Depression Rating Scale (MADRS) Score Change — -21.7; -14.6 summed total scores — p==0.040

Primary: Numeric Pain Rating Scale (NPRS) — 6.09; 6.27; 3.73; 3.82 units on a scale

Primary: Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to…

Primary: Numeric Rating Scale (Pain) — 5.2; 5.2; 5.3 units on a scale

Primary: Reduction in Overstimulation Sensation — 25 Participants — p=<0.001

Primary: Visual Analog Scale (VAS) on Back Pain — 4.83; 4.51; 4.57; 3.22 units on a scale — p=0.002

Primary: Average Pain Reduction Post Intervention — 2.72 score on a scale

Primary: 10-meter Walking Speed (m/Sec) — 0.165; 0.215; 0.13; 0.13 speed (m/sec)

Primary: Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test) — 4.5; 19.4 score change before and after — p=<0.000

Primary: Median Compliance Rate of Using Wearable Devices and Digital Surveys During the SCS Post-implant Period — 58.2; 36.0; 57.0; 44.9 percentage of days

Primary: Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough. — 2.1; 9.6; 10.4; 11.1 L/s — p=<0.05