Spinal Cord Stimulation Efficacy Measures

Status unconfirmed · Phase 1

Conditions studied: Chronic Pain in the Trunk and Limbs

In brief

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.

Key facts

Study ID

NCT00351208

Run by

New York Neurosurgery & Neuroscience Associates, PLLC

People needed

20

Starts

2006-05-01

Expected to finish

2006-08-01

Last updated by the study team

2006-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Brookdale University Hospital and Medical Center — Brooklyn, New York, United States (enrolling)
• New York Neurosurgery & Neuroscience Associates, PLLC — Rockville Centre, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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