Pain, Intractable
Conditions
Keywords
chronic pain, intractable pain, failed back surgery syndrome
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.
Interventions
SCS programming options
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| 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 | 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). |
Countries
United States
Participant flow
Pre-assignment details
All enrolled subjects will undergo a Spinal Cord Stimulation device trial that includes an intraoperative programming trial. Subjects experiencing a positive response (improvement in average overall pain relief) during the trial will move forward with a permanent implant. Those not reporting a positive response will be exited from the study.
Participants by arm
| Arm | Count |
|---|---|
| Open Label Treatment Spinal Cord Stimulation (SCS) | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Device Trial (HD Programming Trial) | Lack of Efficacy | 6 |
| Device Trial (HD Programming Trial) | Withdrawal by Subject | 1 |
| Enrollment | Adverse Event | 1 |
| Enrollment | Inability to implant system | 1 |
| Enrollment | Inclusion/exclusion criteria not met | 4 |
| Enrollment | Insurance issue | 2 |
| Enrollment | Lost to Follow-up | 1 |
| Enrollment | Physician Decision | 2 |
| Enrollment | Protocol Violation | 1 |
| Enrollment | Study closure | 1 |
| Enrollment | Unable to be programmed | 1 |
| Enrollment | Withdrawal by Subject | 6 |
| Implant to 3 Month Endpoint | Adverse Event | 2 |
| Implant to 3 Month Endpoint | Withdrawal by Subject | 1 |
| Successful Trial (≥50% Pain Relief) | Physician Decision | 2 |
| Successful Trial (≥50% Pain Relief) | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Open Label Treatment |
|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 11.9 |
| Average Overall Pain | 7.5 units on a scale STANDARD_DEVIATION 0.9 |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 12 / 48 |
| serious Total, serious adverse events | 1 / 48 |
Outcome results
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).
Time frame: From baseline to 3 months post device activation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Treatment | Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | -3.7 units on a scale | Standard Deviation 2.3 |
Comparison: A negative value for change in pain represents a reduction (improvement) of the subject's pain score. The null hypothesis was that the mean change from baseline to 3 months equals 0. The sample provided over 90% power, with two-sided significance level of 0.05, to detect a change of 2 points.p-value: <0.01t-test, 2 sided
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).
Time frame: From baseline to 3 months post device activation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Label Treatment | Patient Global Impression of Change | 7 - A great deal better | 10 Participants |
| Open Label Treatment | Patient Global Impression of Change | 6 - Better | 12 Participants |
| Open Label Treatment | Patient Global Impression of Change | 5 - Moderately better | 6 Participants |
| Open Label Treatment | Patient Global Impression of Change | 4 - Somewhat better | 1 Participants |
| Open Label Treatment | Patient Global Impression of Change | 3 - A little better | 1 Participants |
| Open Label Treatment | Patient Global Impression of Change | 2 - Almost the same | 2 Participants |
| Open Label Treatment | Patient Global Impression of Change | 1 - No change (or worse) | 0 Participants |
Other Pre-specified
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).
Time frame: From baseline to 3 months post device activation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Treatment | Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | -3.8 units on a scale | Standard Deviation 2 |
Other Pre-specified
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).
Time frame: From baseline to 3 months post device activation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Treatment | Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire | -4.1 units on a scale | Standard Deviation 2.7 |