OPTIONS Spinal Cord Stimulation Programming Parameters
A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.
1 other identifier
interventional
64
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 14, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
September 19, 2017
CompletedSeptember 19, 2017
August 1, 2017
1.1 years
July 14, 2015
July 10, 2017
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
From baseline to 3 months post device activation
Secondary Outcomes (1)
Patient Global Impression of Change
From baseline to 3 months post device activation
Other Outcomes (2)
Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
From baseline to 3 months post device activation
Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
From baseline to 3 months post device activation
Study Arms (1)
Open label treatment
OTHERSpinal Cord Stimulation (SCS)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (11)
Valley Pain Consultants-North Scottsdale
Scottsdale, Arizona, 85254, United States
Synovation Medical Group
Chula Vista, California, 91914, United States
Center for Interventional Pain Spine
Wilmington, Delaware, 19803, United States
Pain Care LLC
Stockbridge, Georgia, 30281, United States
Millennium Pain Center
Bloomington, Illinois, 61701, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106-1716, United States
St. Luke's Neurosurgical Associates
Bethlehem, Pennsylvania, 18018, United States
Precision Spine Care
Tyler, Texas, 75701-4262, United States
Swedish Pain Services
Seattle, Washington, 98122, United States
Northwest Pain Care
Spokane, Washington, 99201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Helen Berrier
- Organization
- Medtronic Implantable Therapies
Study Officials
- STUDY DIRECTOR
OPTIONS Clinical Research Study Team
Medtronic Implantable Therapies
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2015
First Posted
July 21, 2015
Study Start
July 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 19, 2017
Results First Posted
September 19, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share