Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
Trial ID or NCT#
Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. This study aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in the department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). CHOIR uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of high frequency and burst spinal cord stimulation in improving pain and function in patients with chronic back and/or leg pain. Spinal cord stimulation is an effective treatment for chronic pain resulting in >50% pain relief in about half of the patients. Novel waveforms for spinal cord stimulation - high frequency and burst - increased the efficacy of this treatment even further. However, there is lack of data guiding decision making of the clinicians in choosing the best waveform in treating the patients with chronic pain. The proposed study will provide the clinicians with this evidence. Currently, data about safety and efficacy of these two novel waveforms is available for up to 24 months. The proposed research will provide data about effectiveness of these two modalities for at least 36 months. Moreover, this study will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in Stanford Pain Management subspecialty clinic. CHOIR can then be applied for numerous future trials to advance knowledge in perioperative and pain medicine.
Comparing Long-Term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
- 1. Adult English-speaking patient 18 years old or above 2. Persistent pain in lower back and/or leg for more than six months 3. Candidate for spinal cord stimulation (with either high frequency or burst waveforms) based on recommendations from Stanford Pain Management Center Neuromodulation Multidisciplinary Team Conference.
- 1. Motor weakness in neurological examination in lower body based on the assessment by treating pain physicians 2. Previous failed spinal cord stimulation trial with either high frequency or burst waveforms 3. Patient refusal
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Vafi Salmasi, MD.