Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation

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Specific Aims: The investigators are proposing to compare the effectiveness of high frequency and burst spinal cord stimulation in patients with chronic back and/or leg pain. More than one hundred million Americans suffer from chronic pain with estimated annual cost of $635 billion.1 To better chara...

Specific Aims: The investigators are proposing to compare the effectiveness of high frequency and burst spinal cord stimulation in patients with chronic back and/or leg pain. More than one hundred million Americans suffer from chronic pain with estimated annual cost of $635 billion.1 To better characterize these patients, Stanford Pain Management Center has implemented a patient reported registry, Collaborative Health Outcomes Information Registry (CHOIR), since 2012. CHOIR surveys include National Institute of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) item banks, a body map, questions about pain intensity, pain catastrophizing scale, and questions about patients' pain experience and healthcare utilization. This learning healthcare system also has the capability of point-of-care randomization. Spinal cord stimulation is one of the most effective treatments for patients with intractable trunk and limb pain. Traditional tonic spinal cord stimulation resulted in at least 50% pain reduction in about half of the patients.2,3 Newer waveforms - high frequency and burst - achieve 50% pain reduction in 60-75% of the patients in comparison.4-6 However, more studies are needed to compare effectiveness of these two new waveforms. The investigators are proposing to use patient reported outcomes to conduct a pragmatic clinical trial that integrates with patients' clinical care; thus, allowing faster recruitment of a larger patient cohort. The patient's provider will use CHOIR point-of-care randomization to randomly assign patients to either receive high frequency or burst spinal cord stimulation. The patients will then complete online CHOIR surveys sent out to them at baseline and then 1, 3, 6, 12, 18, 24 and 36 months after their device implant. These surveys will include PROMIS item banks for pain interference, function, depression and anxiety; questions about pain intensity; and questions about any potential side effects. The investigators will include patients with chronic (pain for at least 6 months) back and/or leg pain refractory to conventional management. Specific Aim 1: Comparing effectiveness of high frequency and burst spinal cord stimulation in improving pain, function and pain interference in patients with chronic low back and/or leg pain persistent more than 6 months. The investigators hypothesize that high frequency spinal cord stimulation is more effective than burst spinal cord stimulation in decreasing chronic low back and/or leg pain. The investigators' primary outcome is change from baseline in pain intensity at 12 months. The investigators will also compare improvement in function and pain interreference at all follow up time points. The investigators will plot the trend of all these measures and study change from baseline at 12 months. The investigators will use repeated measure linear regression to compare these measures between the groups at follow up time points with time as the fixed effect and treatment as random effect. Specific Aim 2: Comparing effectiveness of high frequency and burst spinal cord stimulation in improving depression and anxiety in patients with chronic low back and/or leg pain persistent more than 6 months. The investigators hypothesize that high frequency spinal cord stimulation is more effective than burst spinal cord stimulation in decreasing stress and anxiety in patients with chronic low back and/or leg pain. Burst stimulation modulates medial thalamic pathway, which attributes adverse emotions to pain. The investigators will therefore compare emotional response to these waveforms. The investigators will compare change from baseline of depression and anxiety at 12 months. The investigators will also plot depression and anxiety trend at all follow up time points between two groups using repeated measure linear regression. The investigators will then perform a similar stratified analysis in responders (patients with 50% or more pain reduction at 1 year) and non-responders to these treatments; this analysis is to asses if pain reduction is an effect measure modifier in this relationship.

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