Spinal Cord Stimulation Frequency Study

Prospective, single-center, double-blinded, randomized crossover of 4 different stimulation frequencies: sham, 1200 Hz, 3030 Hz, and 5882 Hz.

Inclusion criteria

• At least 18 years old at the time of informed consent
• Willing and able to provide a signed and dated informed consent
• Capable of comprehending and consenting in English
• Willing and able to comply with all study procedures, study visits, and be available for the duration of the study
• On a stable dose (no new, discontinued or changes in) of all prescribed pain medications and willing/able to maintain or only decrease the dose of all prescribed pain medications
• Tried appropriate conventional medical management for their pain
• Not indicated for additional surgical treatment in the opinion of the referring physician or spinal surgeon
• Undergone previous spinal surgery
• Diagnosed with FBSS with appropriate pain score
• Primary pain at appropriate spinal level

Exclusion criteria

• Has an active implanted device, whether turned on or off
• Displays current signs of a systemic infection
• Pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
• Has untreated major psychiatric comorbidity
• Has serious drug-related behavioral issues
• Has neurological abnormalities unrelated to Failed Back Surgery Syndrome
• Diagnosed with Raynaud disease
• Diagnosed with Fibromyalgia
• Has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
• Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
• Participating or planning to participate in another clinical trial
• Has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)