Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351208
Status:
UNKNOWN
Last Update Posted:
2006-07-12
First Post:
2006-07-11
Brief Title:
Spinal Cord Stimulation Efficacy Measures
Sponsor:
New York Neurosurgery Neuroscience Associates PLLC
Organization:
New York Neurosurgery Neuroscience Associates PLLC
Study Overview
Official Title:
The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to measure the efficacy of varying spinal cord stimulation frequencies and pulse-width settings on chronic pain management The spinal cord stimulator settings that are most effective in chronic pain management hope to be revealed for the purposes of this study In this double-blind study both the patient and the staff will not be aware of the spinal cord stimulator settings for each patient each week The representative that will set the settings each week will be blinded to the identity of each patient and will set the spinal cord stimulator from another room While there are few papers that show the efficacy of spinal cord stimulation in treating chronic pain there has yet to be a study performed that measures the role of stimulation frequency and pulse-widths This study hopes to be the first
Detailed Description:
For a total of 9 weeks patients will be randomized to 9 stimulation frequency and pulse-width setting combinations The patient will stay with these settings for a week at a time Prior to the patients first office visit heshe will be asked to take a chest x-ray The patient will also repeat this chest x-ray at the end of the study Each patient will be asked to provide daily information regarding pain medication usage spinal cord stimulation usage amplitude settings and pain ratings Additionally patients will fill out the Multidimensional Pain Inventory MPI and the McGill Pain Questionnaire MPQ every Monday when they come to the office before heshe is randomized to the new settings for the week The patient will also receive a call from the research assistant to see how heshe is doing that week and the patient will be provided with all the pertinent contact information to call at any time to ask questions The patient can withdraw from the study completely at any point or drop out of the settings for the week The patient will have a follow-up visit a month from the studys end date to discuss how the patient has been managing hisher pain at hisher spinal cord stimulator settings Each patient will be compensated for completing the study Efficacy will be measured based on the patients answers to the pain probes device usage and medication usage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None