OPTIONS Spinal Cord Stimulation Programming Parameters

Pain, Intractable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503787
• Other study ID #: 1675
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: August 17, 2017
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2017
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Intractable

Intervention

Device:
• Spinal Cord Stimulation (SCS)
SCS programming options

Locations

Country	Name	City	State
United States	St. Luke's Neurosurgical Associates	Bethlehem	Pennsylvania
United States	Millennium Pain Center	Bloomington	Illinois
United States	Synovation Medical Group	Chula Vista	California
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Valley Pain Consultants-North Scottsdale	Scottsdale	Arizona
United States	Swedish Pain Services	Seattle	Washington
United States	Northwest Pain Care	Spokane	Washington
United States	Pain Care LLC	Stockbridge	Georgia
United States	Precision Spine Care	Tyler	Texas
United States	Center for Interventional Pain Spine	Wilmington	Delaware
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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