Spinal Cord Stimulation Frequency Study

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

Official Title
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Randomized Controlled Double-blind Cross-over Trial Evaluating the Role of Frequencies on Spinal Cord Stimulation in the Management of Failed Back Surgery Syndrome (SCS Frequency Study)

Conditions
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Failed Back Surgery Syndrome

Intervention / Treatment
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* Device: Sham
* Device: 1200 Hz
* Device: 3030 Hz
* Device: 5882 Hz


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>Frequency Setting - Sham | Device: Sham<br>* Frequency Setting - Sham<br>|
| Experimental: 1200 Hz<br>Frequency Setting - 1200 Hz | Device: 1200 Hz<br>* Frequency Setting - 1200 Hz<br>|
| Experimental: 3030 Hz<br>Frequency Setting - 3030 Hz | Device: 3030 Hz<br>* Frequency Setting - 3030 Hz<br>|
| Experimental: 5882 Hz<br>Frequency Setting - 5882 Hz | Device: 5882 Hz<br>* Frequency Setting - 5882 Hz<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) on Back Pain | 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. | 12 weeks |