Recruiting
Phase 1

Spinal Cord Stimulation

Sponsor:

New York Neurosurgery & Neuroscience Associates, PLLC

Code:

NCT00351208

Conditions

Chronic Pain in the Trunk and Limbs

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medtronic Manufactured Spinal Cord Stimulators

Study Details

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.

Conditions

Chronic Pain in the Trunk and Limbs

Study ID

NCT00351208

Start date

May, 2006

Status verified date

Jun, 2006

Completion date

Aug, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Medtronic Manufactured Spinal Cord Stimulators

Primary outcome measure

  • Percent pain relief obtained during the one-month follow-up compared to baseline [ Time Frame: undefined ]
  • The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Chandra M Singh, B.S.

(718) 240-8177csingh320@gmail.com

Ronit Frenkel, RPA

(516) 255-0350rfrenkel@nynna.com

Locations

The Brookdale University Hospital and Medical Center

Recruiting

Brooklyn, New York, United States, 11212

Contacts

Chandra M Singh, B.S.

718-240-8177csingh320@gmail.com

Ronit Frenkel, RPA

(516) 255-0350rfrenkel@nynna.com

Principal Investigator:

Louis G Cornacchia, MD

New York Neurosurgery & Neuroscience Associates, PLLC

Recruiting

Rockville Center, New York, United States, 11570

Contacts

Ronit Frenkel, RPA

516-255-0350rfrenkel@nynna.com

Chandra M Singh, B.S.

(718) 240-8177csingh320@gmail.com

Principal Investigator:

Louis G Cornacchia, MD

More Information

Sponsor

New York Neurosurgery & Neuroscience Associates, PLLC

Last update posted

Jul 12, 2006

Last verified

Jun, 2006

Keywords

  • Spinal cord stimulation
  • Spinal cord stimulation efficacy
  • Spinal cord stimulators
  • Stimulation frequencies
  • Stimulation pulse-widths
  • Varying settings

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Neurosurgery & Neuroscience Associates, PLLC on 2006-07-12.