Status:
UNKNOWN
Spinal Cord Stimulation Efficacy Measures
Lead Sponsor:
New York Neurosurgery & Neuroscience Associates, PLLC
Collaborating Sponsors:
MedtronicNeuro
Conditions:
Chronic Pain in the Trunk and Limbs
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 mos...
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 patien...
Eligibility Criteria
Inclusion
- The patient must have SCS implanted for at least 2 months before study start date
- The patient must be at least 18 years old
- The patient must currently be receiving pain relief from SCS usage
- The patient must be willing to participate in a 9-week study
- The patient must have at least 20% of battery life remaining in his/her spinal cord stimulator
- The patient must be able to tolerate Vicodin-Extra Strength as well as Tylenol, but can also take their own pain medication if it is not one of the two mentioned
Exclusion
- The patient is pregnant or intends to become pregnant during the course of the study.
- The patient by report, and/or by physician assessment, exhibits any or all of the following, which might bias reporting of treatment outcome:
- A strong untreated dependency on prescription medication such as benzodiazepines and narcotic analgesics.
- A strong potential for secondary gain issues.
- A significant, untreated psychiatric comorbidity.
- The patient possesses a coexisting clinically relevant or disabling chronic pain problem not treated by SCS
- The patient has been diagnosed with unstable angina
- The patient receives a Karnofsky's performance score of \<60
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00351208
Start Date
May 1 2006
End Date
August 1 2006
Last Update
July 12 2006
Active Locations (2)
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1
The Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
2
New York Neurosurgery & Neuroscience Associates, PLLC
Rockville Centre, New York, United States, 11570