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OPTIONS Spinal Cord Stimulation Programming Parameters

Primary Purpose

Pain, Intractable

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulation (SCS)
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Intractable focused on measuring chronic pain, intractable pain, failed back surgery syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Valley Pain Consultants-North Scottsdale
  • Synovation Medical Group
  • Center for Interventional Pain Spine
  • Pain Care LLC
  • Millennium Pain Center
  • The Center for Clinical Research
  • University Hospitals Case Medical Center
  • St. Luke's Neurosurgical Associates
  • Precision Spine Care
  • Swedish Pain Services
  • Northwest Pain Care

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open label treatment

Arm Description

Spinal Cord Stimulation (SCS)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
July 14, 2015
Last Updated
August 17, 2017
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT02503787
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Intractable
Keywords
chronic pain, intractable pain, failed back surgery syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label treatment
Arm Type
Other
Arm Description
Spinal Cord Stimulation (SCS)
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation (SCS)
Intervention Description
SCS programming options
Primary Outcome Measure Information:
Title
Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
Description
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).
Time Frame
From baseline to 3 months post device activation
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change
Description
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).
Time Frame
From baseline to 3 months post device activation
Other Pre-specified Outcome Measures:
Title
Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
Description
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).
Time Frame
From baseline to 3 months post device activation
Title
Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire
Description
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).
Time Frame
From baseline to 3 months post device activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OPTIONS Clinical Research Study Team
Organizational Affiliation
Medtronic Implantable Therapies
Official's Role
Study Director
Facility Information:
Facility Name
Valley Pain Consultants-North Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Synovation Medical Group
City
Chula Vista
State/Province
California
ZIP/Postal Code
91914
Country
United States
Facility Name
Center for Interventional Pain Spine
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Pain Care LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1716
Country
United States
Facility Name
St. Luke's Neurosurgical Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18018
Country
United States
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4262
Country
United States
Facility Name
Swedish Pain Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Northwest Pain Care
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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