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
Sponsor MedtronicNeuro
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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Frequency Setting 1
medtronic restoresensor frequency setting 1
Frequency Setting 1
Frequency Setting 2
medtronic restoresensor frequency setting 2
Frequency Setting 2
Frequency Setting 3
medtronic restoresensor frequency setting 3
Frequency Setting 3
(Sham Comparator)
Frequency Setting 4
medtronic restoresensor frequency setting 4
Frequency Setting 4

Primary Outcomes

Visual Analog Pain Scale
time frame: 12 weeks

Eligibility Criteria

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by MedtronicNeuro.