OPTIONS Spinal Cord Stimulation Programming Parameters

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Open label treatment	Spinal Cord Stimulation (SCS)	Spinal Cord Stimulation (SCS)

Primary Outcome Measures

Name	Time	Method
Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire	From baseline to 3 months post device activation	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).

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change	From baseline to 3 months post device activation	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).

Locations (11): Synovation Medical Group
🇺🇸
Chula Vista, California, United States
Center for Interventional Pain Spine
🇺🇸
Wilmington, Delaware, United States
Pain Care LLC
🇺🇸
Stockbridge, Georgia, United States
The Center for Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States
University Hospitals Case Medical Center
🇺🇸
Cleveland, Ohio, United States
St. Luke's Neurosurgical Associates
🇺🇸
Bethlehem, Pennsylvania, United States
Precision Spine Care
🇺🇸
Tyler, Texas, United States
Swedish Pain Services
🇺🇸
Seattle, Washington, United States
Northwest Pain Care
🇺🇸
Spokane, Washington, United States
Valley Pain Consultants-North Scottsdale
🇺🇸
Scottsdale, Arizona, United States
Millennium Pain Center
🇺🇸
Bloomington, Illinois, United States