OPTIONS Spinal Cord Stimulation Programming Parameters

A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Intractable
• Intervention / Treatment: Device: Spinal Cord Stimulation (SCS)

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Valley Pain Consultants-North Scottsdale
  • California
    • Chula Vista, California, United States, 91914
      • Synovation Medical Group
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Center for Interventional Pain Spine
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Pain Care LLC
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Millennium Pain Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44106-1716
      • University Hospitals Case Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18018
      • St. Luke's Neurosurgical Associates
  • Texas
    • Tyler, Texas, United States, 75701-4262
      • Precision Spine Care
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Pain Services
    • Spokane, Washington, United States, 99201
      • Northwest Pain Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open label treatment; Spinal Cord Stimulation (SCS)	Device: Spinal Cord Stimulation (SCS); SCS programming options

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From baseline to 3 months post device activation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire	Self reported daily average back 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
Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire	Self reported daily average leg 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

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Study Director: OPTIONS Clinical Research Study Team, Medtronic Implantable Therapies

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: chronic pain; intractable pain; failed back surgery syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Intractable
• Other Study ID Numbers: 1675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No