Spinal Cord Stimulation Frequency Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by MedtronicNeuro
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01750229
First received: November 19, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention
Failed Back Surgery Syndrome
Device: Medtronic RestoreSensor Frequency Setting 1
Device: Medtronic RestoreSensor Frequency Setting 2
Device: Medtronic RestoreSensor Frequency Setting 3
Device: Medtronic RestoreSensor Frequency Setting 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Visual Analog Pain Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medtronic RestoreSensor Frequency Setting 1
Frequency Setting 1
Device: Medtronic RestoreSensor Frequency Setting 1
Frequency Setting 1
Experimental: Medtronic RestoreSensor Frequency Setting 2
Frequency Setting 2
Device: Medtronic RestoreSensor Frequency Setting 2
Frequency Setting 2
Experimental: Medtronic RestoreSensor Frequency Setting 3
Frequency Setting 3
Device: Medtronic RestoreSensor Frequency Setting 3
Frequency Setting 3
Sham Comparator: Medtronic RestoreSensor Frequency Setting 4
Frequency Setting 4
Device: Medtronic RestoreSensor Frequency Setting 4
Frequency Setting 4

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750229

Contacts
Contact: SCSFrequency Clinical Research Study Team medtronicneurotrials@medtronic.com

Locations
United Kingdom
Guy's and St. Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Adnan Al-Kaisy, Dr.         
Contact: Emma Hudson       EMMA.HUDSON@GSTT.NHS.UK   
Sponsors and Collaborators
MedtronicNeuro
Investigators
Principal Investigator: Adnan Al-Kaisy, Dr. Guy's and St Thomas' NHS Foundation Trust
  More Information

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01750229     History of Changes
Other Study ID Numbers: 1668
Study First Received: November 19, 2012
Last Updated: July 28, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 28, 2014