Comparison of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Pain Relief
Chronic Pain
About this trial
This is an interventional diagnostic trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Subject must be 18 years and older, and younger than 75 years of age.
- Subject has had a Precision Spectra, or Plus spinal cord stimulator system implanted for chronic painful condition.
- Subject continues to receive adequate pain relief with greater than or equal to 50% pain relief based on pre-trial and pre-implant pain assessment.
- Device age should not be less than 2 months old.
- Subject is willing to comply with all requirements of the study.
Exclusion Criteria:
- Subjects who are getting <50% pain relief on current SCS based on pre-trial and pre-implant pain assessment.
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
- Unstable medical or psychiatric illness
- Urine drug screen shows controlled substance/s not prescribed by the prescribers.
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- Substance abuse in the last 6 months
- Pregnant or breastfeeding
- Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- Treatment with investigational drug within 30 days of screening.
Sites / Locations
- Jason Hong
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Treatment group A
Treatment group B
Group A will consist of sequence of treatment with 3 stimulation modes. They are, in order, 1000 hertz, standard, and burst stimulation. Each stimulation modes will last 3 weeks, with 4 days of wash off between them. Each group treatments will take about 3 months, and subject will cross over into the other treatment group. Burst stimulation sends packets of electrical pulses, composed of pulse and packet frequency. 1000 hertz stimulation delivers tonic, sub perception stimulation. The standard stimulation mode, which will serve as the control, will be below 100 hertz, and its pulse strength will be above threshold, where patients will feel the tingling from the electrical pulses generated by the spinal cord stimulator.
Group B will consist of sequence of treatment with 3 stimulation modes. They are, in order, burst stimulation, standard, and 1000 hertz. Each stimulation modes will last 3 weeks, with 4 days of wash off between them. Each group treatments will take about 3 months, and subject will cross over into the other treatment group. Burst stimulation sends packets of electrical pulses, composed of pulse and packet frequency. 1000 hertz stimulation delivers tonic, sub perception stimulation. The standard stimulation mode, which will serve as the control, will be below 100 hertz, and its pulse strength will be above threshold, where patients will feel the tingling from the electrical pulses generated by the spinal cord stimulator.