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Spinal Cord Stimulation Efficacy Measures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351208
Recruitment Status : Unknown
Verified June 2006 by New York Neurosurgery & Neuroscience Associates, PLLC.
Recruitment status was:  Recruiting
First Posted : July 12, 2006
Last Update Posted : July 12, 2006
Information provided by:
New York Neurosurgery & Neuroscience Associates, PLLC

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.

Condition or disease Intervention/treatment Phase
Chronic Pain in the Trunk and Limbs Device: Medtronic Manufactured Spinal Cord Stimulators Phase 1

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 patient's first office visit, he/she 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 he/she is randomized to the new settings for the week. The patient will also receive a call from the research assistant to see how he/she 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 study's end date to discuss how the patient has been managing his/her pain at his/her spinal cord stimulator settings. Each patient will be compensated for completing the study. Efficacy will be measured based on the patient's answers to the pain probes, device usage, and medication usage.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths
Study Start Date : May 2006
Estimated Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Primary Outcome Measures :
  1. Percent pain relief obtained during the one-month follow-up compared to baseline
  2. The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351208

Contact: Chandra M Singh, B.S. (718) 240-8177
Contact: Ronit Frenkel, RPA (516) 255-0350

United States, New York
The Brookdale University Hospital and Medical Center Recruiting
Brooklyn, New York, United States, 11212
Contact: Chandra M Singh, B.S.    718-240-8177   
Contact: Ronit Frenkel, RPA    (516) 255-0350   
Principal Investigator: Louis G Cornacchia, MD         
New York Neurosurgery & Neuroscience Associates, PLLC Recruiting
Rockville Center, New York, United States, 11570
Contact: Ronit Frenkel, RPA    516-255-0350   
Contact: Chandra M Singh, B.S.    (718) 240-8177   
Principal Investigator: Louis G Cornacchia, MD         
Sponsors and Collaborators
New York Neurosurgery & Neuroscience Associates, PLLC
Principal Investigator: Louis G Cornacchia, MD New York Neurosurgery & Neuroscience Associates, PLLC

Publications: Identifier: NCT00351208     History of Changes
Other Study ID Numbers: 05-20-
First Posted: July 12, 2006    Key Record Dates
Last Update Posted: July 12, 2006
Last Verified: June 2006

Keywords provided by New York Neurosurgery & Neuroscience Associates, PLLC:
Spinal cord stimulation
Spinal cord stimulation efficacy
Spinal cord stimulators
Stimulation frequencies
Stimulation pulse-widths
Varying settings

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms