Spinal Cord Stimulation Frequency Study
This study is currently recruiting participants.
Verified January 2013 by MedtronicNeuro
Sponsor:
MedtronicNeuro
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01750229
First received: November 19, 2012
Last updated: January 2, 2013
Last verified: January 2013
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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 FBSS
- 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
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: | January 2, 2013 |
| 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 May 23, 2013