Spinal Cord Stimulation Efficacy Measures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by New York Neurosurgery & Neuroscience Associates, PLLC.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
MedtronicNeuro
Information provided by:
New York Neurosurgery & Neuroscience Associates, PLLC
ClinicalTrials.gov Identifier:
NCT00351208
First received: July 11, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Pain in the Trunk and Limbs
Device: Medtronic Manufactured Spinal Cord Stimulators
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths

Resource links provided by NLM:


Further study details as provided by New York Neurosurgery & Neuroscience Associates, PLLC:

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

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351208

Contacts
Contact: Chandra M Singh, B.S. (718) 240-8177 csingh320@gmail.com
Contact: Ronit Frenkel, RPA (516) 255-0350 rfrenkel@nynna.com

Locations
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    csingh320@gmail.com   
Contact: Ronit Frenkel, RPA    (516) 255-0350    rfrenkel@nynna.com   
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    rfrenkel@nynna.com   
Contact: Chandra M Singh, B.S.    (718) 240-8177    csingh320@gmail.com   
Principal Investigator: Louis G Cornacchia, MD         
Sponsors and Collaborators
New York Neurosurgery & Neuroscience Associates, PLLC
MedtronicNeuro
Investigators
Principal Investigator: Louis G Cornacchia, MD New York Neurosurgery & Neuroscience Associates, PLLC
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00351208     History of Changes
Other Study ID Numbers: 05-20-
Study First Received: July 11, 2006
Last Updated: July 11, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014