OPTIONS Spinal Cord Stimulation Programming Parameters

MedtronicNeuro64 enrolled

Overview

The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.

Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study. The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Intractable

Interventions

Spinal Cord Stimulation (SCS)DEVICE

SCS programming options

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain) * Willing and able to provide a signed and dated informed consent * At least 18 years old at the time of informed consent * Willing and able to attend visits and comply with the study protocol * Capable of using the patient programmer and recharging the neurostimulator * Willing to not increase pain medications from baseline through the 3-Month Visit Exclusion Criteria: * Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results. * Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol. * Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system * Implanted with a cardiac device (e.g., pacemaker, defibrillator)

Locations (11)

Valley Pain Consultants-North Scottsdale

Scottsdale, Arizona, United States

Synovation Medical Group

Chula Vista, California, United States

Center for Interventional Pain Spine

Wilmington, Delaware, United States

Outcomes

Primary Outcomes

Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire

Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).

Time frame: From baseline to 3 months post device activation

Secondary Outcomes

Patient Global Impression of Change

Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference).

Time frame: From baseline to 3 months post device activation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.