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OPTIONS Spinal Cord Stimulation Programming Parameters

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ClinicalTrials.gov Identifier: NCT02503787
Recruitment Status : Completed
First Posted : July 21, 2015
Results First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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.

Condition or disease Intervention/treatment Phase
Pain, Intractable Device: Spinal Cord Stimulation (SCS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.
Study Start Date : July 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Open label treatment
Spinal Cord Stimulation (SCS)
Device: Spinal Cord Stimulation (SCS)
SCS programming options




Primary Outcome Measures :
  1. Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire [ Time Frame: 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 :
  1. Patient Global Impression of Change [ Time Frame: 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).


Other Outcome Measures:
  1. Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire [ Time Frame: From baseline to 3 months post device activation ]
    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).

  2. Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire [ Time Frame: From baseline to 3 months post device activation ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503787


Locations
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United States, Arizona
Valley Pain Consultants-North Scottsdale
Scottsdale, Arizona, United States, 85254
United States, California
Synovation Medical Group
Chula Vista, California, United States, 91914
United States, Delaware
Center for Interventional Pain Spine
Wilmington, Delaware, United States, 19803
United States, Georgia
Pain Care LLC
Stockbridge, Georgia, United States, 30281
United States, Illinois
Millennium Pain Center
Bloomington, Illinois, United States, 61701
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106-1716
United States, Pennsylvania
St. Luke's Neurosurgical Associates
Bethlehem, Pennsylvania, United States, 18018
United States, Texas
Precision Spine Care
Tyler, Texas, United States, 75701-4262
United States, Washington
Swedish Pain Services
Seattle, Washington, United States, 98122
Northwest Pain Care
Spokane, Washington, United States, 99201
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Study Director: OPTIONS Clinical Research Study Team Medtronic Implantable Therapies
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT02503787    
Other Study ID Numbers: 1675
First Posted: July 21, 2015    Key Record Dates
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by MedtronicNeuro:
chronic pain
intractable pain
failed back surgery syndrome
Additional relevant MeSH terms:
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Pain, Intractable
Pain
Neurologic Manifestations