Spinal Cord Stimulation Frequency Study
This trial is active, not recruiting.
|Condition||failed back surgery syndrome|
|Treatments||medtronic restoresensor frequency setting 1, medtronic restoresensor frequency setting 2, medtronic restoresensor frequency setting 3, medtronic restoresensor frequency setting 4|
|Start date||December 2012|
|End date||September 2015|
|Trial size||60 participants|
|Trial identifier||NCT01750229, 1668|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Visual Analog Pain Scale
time frame: 12 weeks
Male or female participants at least 18 years old.
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)
|Official title||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)|
|Principal investigator||Adnan Al-Kaisy, Dr.|
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