Spinal Cord Stimulation Frequency Study

Not Applicable

Completed

Brief Summary: The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).

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

Recruitment & Eligibility

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)

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) on Back Pain	12 weeks	Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from the last three days of diary prior to the follow-up visits were used for analysis.

Secondary Outcome Measures