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Spinal Cord Stimulation Frequency Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01750229
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Tracking Information
First Submitted Date  ICMJE November 19, 2012
First Posted Date  ICMJE December 17, 2012
Results First Submitted Date  ICMJE March 16, 2017
Results First Posted Date  ICMJE December 18, 2017
Last Update Posted Date December 18, 2017
Study Start Date  ICMJE December 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
Visual Analog Scale (VAS) on Back Pain [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
Visual Analog Pain Scale [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Stimulation Frequency Study
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Failed Back Surgery Syndrome
Intervention  ICMJE
  • Device: Sham
    Frequency Setting - Sham
  • Device: 1200 Hz
    Frequency Setting - 1200 Hz
  • Device: 3030 Hz
    Frequency Setting - 3030 Hz
  • Device: 5882 Hz
    Frequency Setting - 5882 Hz
Study Arms  ICMJE
  • Sham Comparator: Sham
    Frequency Setting - Sham
    Intervention: Device: Sham
  • Experimental: 1200 Hz
    Frequency Setting - 1200 Hz
    Intervention: Device: 1200 Hz
  • Experimental: 3030 Hz
    Frequency Setting - 3030 Hz
    Intervention: Device: 3030 Hz
  • Experimental: 5882 Hz
    Frequency Setting - 5882 Hz
    Intervention: Device: 5882 Hz
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2017)
53
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2012)
60
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01750229
Other Study ID Numbers  ICMJE 1668
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MedtronicNeuro
Study Sponsor  ICMJE MedtronicNeuro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adnan Al-Kaisy, Dr. Guy's and St Thomas' NHS Foundation Trust
PRS Account MedtronicNeuro
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP