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: Changes in Patient Reported Pain and Discomfort — 47; 13; -30; -18 percent change from baseline

Primary: Feasibility - Pain Consultation — 29 Participants

Primary: Change From Baseline in the Numerical Rating Pain Scale (NRS) — 1.87; 1.81 units on a scale

Primary: Change in Numerical Rating Scale Pain Scores (NRS) With Activity — 8.40; 8.00; 4.13; 4.19 Score on a scale

Primary: Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12 — -11.6; -6.0 Morphine Milligram Equivalents (MME) — p=0.31

Primary: Number of Participants With Clinical Success at the 6-Month Visit — 25 Participants

Primary: Patient's Assessment of Pain Severity Score — 7.12; 3.32 Units on a scale

Primary: Change in Quantitative Pain Testing Following Active TMS Compared to Baseline — 1.4; .3 Change from Baseline (degrees C) — p=.83

Primary: Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation — 32 Participants

Primary: Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI) — -25.3; -4.4 units on a scale — p=<0.001

Primary: Number of Patients That Experienced a Treatment-emergent Adverse Event — 490 Participants

Primary: The Proportion of Subjects Reporting at Least 50% Overall Pain Relief — 19; 14; 10; 16 Participants — p=.196

Primary: Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy — 93.5; 36.4 percentage of participants

Primary: Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) — 5.05; 5.02 units on a scale — p=0.934

Primary: The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment. — -1.32; -0.93; -0.73 units on a scale — p=0.014

Primary: Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed. — 97.8 % of programmed vol…

Primary: Patient Controlled Analgesia (PCA) Hydromorphone Usage — 44; 39 mL

Primary: Morphine Consumption in the First 48 Hours After Surgery — 309; 195 mg

Primary: Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI) — -3.23; -15.24; -1.50; -18.40 Units on a scale

Primary: LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline — 25.95 units on a scale of 0 to 100 points — p=0.001

Primary: Assessment of Opioid Use Via Subject Report — 47.5; 21.75 morphine milligram equivalent

Primary: Composite Pain Severity — 5.6; 5.6 score on a scale

Primary: Pain Intensity — 5.43; 5.92; 5.28; 4.75 units on a scale

Primary: Brief Pain Inventory (Pain) — 3.57; 4.59 units on a scale

Primary: Change in Cold Pressor Test (CPT) Latency — 21.40; 10.94; 2.07; 15.17 percent change from Day 1 baseline

Primary: Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment — 7.2; 9.5 percent improvement — p=0.2735

Primary: "Average" Phantom Limb Pain Intensity 4 Weeks Following Initiation of an Ambulatory Continuous Peripheral Nerve Block (as Measured by the Numeric Rating Scale Within the…

Primary: Change in Pain Relative to Baseline and After a Trial Period — 4.2; 2.4 Score on a 11 point scale

Primary: Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery — 11.4; 12.9; 15.4 units on a scale — p=<0.01