A randomized controlled with cross over study compares efficacy of burst stimulation, 1000 hertz stimulation, and standard stimulation in an non-superiority trial. The study duration is approximately 24 weeks and each stimulation modes will last for approximately 3 weeks with approximately 4 days of wash off in between.
Study will enroll 22 patients for the purpose of evaluation of efficacy of burst stimulation, 1000 hertz frequency stimulation or standard stimulation in patients who have a spinal cord stimulators implanted. Each patients will be randomized to either group A or B, where each groups consists of Burst, standard, and 1000 hertz frequency stimulation or vice versa with wash off period in between. The duration for each stimulation modes will be approximately 3 weeks, with approximately 4 days of wash off prior to starting the new stimulation mode and in between stimulation modes. Treatment duration for each groups will last about 3 months or less, and with cross over total duration of the study is about 6 months in total. During the trial there will be 13 visits. The first visit will consist of screening visit activities and once the eligibility of the subjects are confirmed, they will be randomized and they can start the study immediately and begin their wash off period. After the initial visit/ randomization visit, there will be 12 follow up visits. At each visit, patients will be assessed for their pain, disability index, and their perception of their painful condition, as well as any adverse events and changes of medication usage or lack there of. At the end of the study, the data will be pooled to look at the pain level, disability index, and patients perceived changes in their painful condition for each treatment groups (Burst stimulation, 1000 hertz stimulation and standard stimulation) to determine if subject experienced equivocal pain relief from all three stimulation modes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
20
Spinal cord stimulator will be programmed to deliver, according to the randomization status of the patient, burst, 1000 hertz, and standard stimulation during each treatment group.
Jason Hong
Winston-Salem, North Carolina, United States
NPRS
Pain rating on 10 point digital scale for average, best, worst, during last week, and current pain level to be collected at each follow up visits. Collected data for each stimulation modes will be compared against each other to assess efficacy of 1000 hertz, and burst stimulation against each other and against the standard stimulation to look for differences in pain rating among three stimulation modes. Data comparison will occur at the end of the study, which is expected to last about 6 months.
Time frame: 3 weeks, and 4 days
Oswestry Disability Index
Set of questionnaires designed to assess the level of disability in chronic pain patients. Each patients will be assessed with this questionnaires at each follow up visits. Collected data for each stimulation modes will be compared against each other to assess effects of 1000 hertz, and burst stimulation against each other and against the standard stimulation on Oswestry Disability Index, and changes if any.
Time frame: 3 weeks, and 4 days
Patients Global Impression of Change
Patient's assessment of the improvement or worsening of their painful condition during the study, and these will be collected at each follow up visits. Collected data for each stimulation modes will be compared against each other to assess effects of 1000 hertz, and burst stimulation against each other and against the standard stimulation on PGIC scores, and changes if any.
Time frame: 3 weeks, and 4 days
Preferability Survey
subject preference of one stimulation program out of 3 received
Time frame: 3, and 6 months; at the completion of each treatment groups.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.