Clinical trial NCT02503787: OPTIONS Spinal Cord Stimulation Programming Parameters
Official title: A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Intractable
Keywords: chronic pain
intractable pain
failed back surgery syndrome
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2015-07-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
timeFrame: From baseline to 3 months post device activation
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: From baseline to 3 months post device activation
Other outcomes:
measure: Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
timeFrame: From baseline to 3 months post device activation
measure: Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
timeFrame: From baseline to 3 months post device activation
Locations:
city: Scottsdale
country: United States
facility: Valley Pain Consultants-North Scottsdale
state: Arizona
city: Chula Vista
country: United States
facility: Synovation Medical Group
state: California
city: Wilmington
country: United States
facility: Center for Interventional Pain Spine
state: Delaware
city: Stockbridge
country: United States
facility: Pain Care LLC
state: Georgia
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's Neurosurgical Associates
state: Pennsylvania
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Seattle
country: United States
facility: Swedish Pain Services
state: Washington
city: Spokane
country: United States
facility: Northwest Pain Care
state: Washington
Study officials:
affiliation: Medtronic Implantable Therapies
name: OPTIONS Clinical Research Study Team
role: STUDY_DIRECTOR
References: