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Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
Not Recruiting
Trial ID: NCT03681262
Purpose
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.
Official Title
Comparing Long-Term Effectiveness of High Frequency and Burst Spinal Cord Stimulation
Stanford Investigator(s)
Vafi Salmasi
Assistant Professor of Anesthesiology, Perioperative and Pain Medicine (Adult Pain)
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
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
Intervention(s):
device: High frequency spinal cord stimulation
device: Burst spinal cord stimulation
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Vafi Salmasi, MD.
6507250246