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Spinal Cord Stimulation Frequency Study

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ClinicalTrials.gov Identifier: NCT01750229
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Failed Back Surgery Syndrome Device: Sham Device: 1200 Hz Device: 3030 Hz Device: 5882 Hz

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2012
Primary Completion Date : August 2016
Study Completion Date : August 2016

Arm Intervention/treatment
Sham Comparator: Sham
Frequency Setting - Sham
Device: Sham
Frequency Setting - Sham
Experimental: 1200 Hz
Frequency Setting - 1200 Hz
Device: 1200 Hz
Frequency Setting - 1200 Hz
Experimental: 3030 Hz
Frequency Setting - 3030 Hz
Device: 3030 Hz
Frequency Setting - 3030 Hz
Experimental: 5882 Hz
Frequency Setting - 5882 Hz
Device: 5882 Hz
Frequency Setting - 5882 Hz

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750229

United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Principal Investigator: Adnan Al-Kaisy, Dr. Guy's and St Thomas' NHS Foundation Trust

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01750229     History of Changes
Other Study ID Numbers: 1668
First Posted: December 17, 2012    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Failed Back Surgery Syndrome
Pathologic Processes
Back Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Signs and Symptoms