High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System (HFSCS)
Chronic Pain, Low Back Pain, Radiculopathy
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Spinal cord stimulation, Chronic pain, Chronic low back pain, Radiculopathy, Complex Regional Pain Syndrome (CRPS), High Frequency stimulation
Eligibility Criteria
Inclusion Criteria:
- Subject must be 18 years and older, and younger than 70 years of age.
- Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
- Subject pain scores >5 on NPRS
Exclusion Criteria:
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
- Unstable medical or psychiatric illness
- 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.
- Concomitant medication exclusions consisting of medications or herbal agents with central nervous system (CNS) effects with exception of episodic use of sedating antihistamines
Sites / Locations
- Center for Clinical Research
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Treatment group A
Treatment group B
Subjects assigned to treatment group A will begin the 7 week study with high frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
Subjects assigned to treatment group B will begin the 7 week study with low frequency stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.