Trial Outcomes & Findings for Burst Spinal Cord Stimulation (Burst-SCS) Study (NCT NCT03718325)
NCT ID: NCT03718325
Last Updated: 2025-11-13
Results Overview
Visual analog scale (VAS) was a horizontal line 100 millimeters (mm) in length with the word "no pain" and "worst possible pain" printed below. The participant marked on the line the point that they felt represented their perception of their current state. The score was determined by measuring in millimeters from the left hand with a total range of 0-100 millimeters, with a score between 0 (no pain) to a score of 100 (worst possible pain). Higher VAS values represented more severe pain and lower values represented lower pain. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain) and positive values indicate worsening (increased pain). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.
TERMINATED
NA
12 participants
Up to one month following the pre-implant visit.
2025-11-13
Participant Flow
Twelve participants were enrolled and had baseline data collected, with nine proceeding to randomization. There were no washout periods between points of data collection during the crossover phase of the trial.
Participant milestones
| Measure |
Un-randomized Participants
Participants who were evaluated at baseline but did not undergo randomization. Un-randomized participants did not receive any SCS as part of the research study.
|
Burst-SCS/Sham-SCS
First, participants will receive Burst-SCS. Study evaluations will be completed prior to and after stimulation. Then, participants will have their stimulation adjusted to receive sham (no) SCS. Study evaluations will be completed prior to and after this sham.
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
|
Sham-SCS/Burst-SCS
First, participants will receive sham (no) SCS. Study evaluations will be completed prior to and after this sham. Then, participants will have their stimulation adjusted to receive Burst-SCS. Study evaluations will be completed prior to and after stimulation.
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
5
|
|
Overall Study
Period 1 (up to 28 Days After Baseline Visit)
|
0
|
4
|
5
|
|
Overall Study
Period 2 (up to 1 Day After Period 1 Visit)
|
0
|
4
|
5
|
|
Overall Study
COMPLETED
|
0
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Un-randomized Participants
Participants who were evaluated at baseline but did not undergo randomization. Un-randomized participants did not receive any SCS as part of the research study.
|
Burst-SCS/Sham-SCS
First, participants will receive Burst-SCS. Study evaluations will be completed prior to and after stimulation. Then, participants will have their stimulation adjusted to receive sham (no) SCS. Study evaluations will be completed prior to and after this sham.
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
|
Sham-SCS/Burst-SCS
First, participants will receive sham (no) SCS. Study evaluations will be completed prior to and after this sham. Then, participants will have their stimulation adjusted to receive Burst-SCS. Study evaluations will be completed prior to and after stimulation.
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
|
|---|---|---|---|
|
Overall Study
Externalized leads were removed independent of the research protocol
|
2
|
0
|
0
|
|
Overall Study
Lost to follow-up because of research pause caused by the COVID-19 pandemic
|
1
|
0
|
0
|
Baseline Characteristics
Burst Spinal Cord Stimulation (Burst-SCS) Study
Baseline characteristics by cohort
| Measure |
Burst-SCS/Sham-SCS
n=4 Participants
First, participants will receive Burst-SCS. Study evaluations will be completed prior to and after stimulation. Then, participants will have their stimulation adjusted to receive sham (no) SCS. Study evaluations will be completed prior to and after this sham.
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
|
Sham-SCS/Burst-SCS
n=5 Participants
First, participants will receive sham (no) SCS. Study evaluations will be completed prior to and after this sham. Then, participants will have their stimulation adjusted to receive Burst-SCS. Study evaluations will be completed prior to and after stimulation.
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
|
Un-randomized Participants
n=3 Participants
Participants who were evaluated at baseline but did not undergo randomization. Un-randomized participants did not receive any SCS as part of the research study.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 10.1 • n=10 Participants
|
51.8 years
STANDARD_DEVIATION 8.64 • n=10 Participants
|
48.7 years
STANDARD_DEVIATION 6.81 • n=20 Participants
|
50.6 years
STANDARD_DEVIATION 8.06 • n=45 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
12 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
12 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
12 Participants
n=45 Participants
|
|
Visual Analog Scale (VAS) Score
|
71.2 score on a scale
STANDARD_DEVIATION 9.60 • n=10 Participants
|
78.4 score on a scale
STANDARD_DEVIATION 15.0 • n=10 Participants
|
83.7 score on a scale
STANDARD_DEVIATION 5.20 • n=20 Participants
|
76.8 score on a scale
STANDARD_DEVIATION 12.0 • n=45 Participants
|
|
Short-Form McGill Pain Questionnaire (SFMPQ) Score
|
26 score on a scale
STANDARD_DEVIATION 11.2 • n=10 Participants
|
19.6 score on a scale
STANDARD_DEVIATION 10.7 • n=10 Participants
|
22.7 score on a scale
STANDARD_DEVIATION 1.53 • n=20 Participants
|
22.5 score on a scale
STANDARD_DEVIATION 9.20 • n=45 Participants
|
|
General Pain Disability Index (PDI) Score
|
36.3 score on a scale
STANDARD_DEVIATION 5.62 • n=10 Participants
|
30.6 score on a scale
STANDARD_DEVIATION 11.9 • n=10 Participants
|
24.7 score on a scale
STANDARD_DEVIATION 17.0 • n=20 Participants
|
31 score on a scale
STANDARD_DEVIATION 11.6 • n=45 Participants
|
|
Brief Pain Inventory-Short Form (BPI-SF) Score
|
6.84 score on a scale
STANDARD_DEVIATION 0.71 • n=10 Participants
|
6.59 score on a scale
STANDARD_DEVIATION 2.19 • n=10 Participants
|
6.12 score on a scale
STANDARD_DEVIATION 1.36 • n=20 Participants
|
6.56 score on a scale
STANDARD_DEVIATION 1.52 • n=45 Participants
|
|
Michigan Body Map (MBM)
|
4.5 checked boxes
STANDARD_DEVIATION 5.69 • n=10 Participants
|
7.2 checked boxes
STANDARD_DEVIATION 5.45 • n=10 Participants
|
11.3 checked boxes
STANDARD_DEVIATION 7.77 • n=20 Participants
|
7.33 checked boxes
STANDARD_DEVIATION 6.14 • n=45 Participants
|
|
Fibromyalgia Survey Questionnaire (FSQ) - Widespread Pain Index
|
3.25 score on a scale
STANDARD_DEVIATION 3.86 • n=10 Participants
|
3.8 score on a scale
STANDARD_DEVIATION 2.05 • n=10 Participants
|
5.67 score on a scale
STANDARD_DEVIATION 2.52 • n=20 Participants
|
4.08 score on a scale
STANDARD_DEVIATION 2.78 • n=45 Participants
|
|
Fibromyalgia Survey Questionnaire (FSQ) - Symptom Severity Index
|
7.00 score on a scale
STANDARD_DEVIATION 2.16 • n=10 Participants
|
3.20 score on a scale
STANDARD_DEVIATION 1.92 • n=10 Participants
|
5.67 score on a scale
STANDARD_DEVIATION 0.58 • n=20 Participants
|
5.08 score on a scale
STANDARD_DEVIATION 2.39 • n=45 Participants
|
PRIMARY outcome
Timeframe: Up to one month following the pre-implant visit.Population: Of the 9 randomized participants, usable data was only obtained from 3 participants due to protocol deviations.
Visual analog scale (VAS) was a horizontal line 100 millimeters (mm) in length with the word "no pain" and "worst possible pain" printed below. The participant marked on the line the point that they felt represented their perception of their current state. The score was determined by measuring in millimeters from the left hand with a total range of 0-100 millimeters, with a score between 0 (no pain) to a score of 100 (worst possible pain). Higher VAS values represented more severe pain and lower values represented lower pain. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain) and positive values indicate worsening (increased pain). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.
Outcome measures
| Measure |
Change of Burst-SCS From Pre-implant
n=3 Participants
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
Change of Sham-SCS From Pre-implant
n=3 Participants
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
|---|---|---|
|
Change in Visual Analog Scale (VAS) Score
Baseline - Usable Data
|
81.1 score on a scale
Standard Deviation 20.1
|
81.1 score on a scale
Standard Deviation 20.1
|
|
Change in Visual Analog Scale (VAS) Score
Change - Usable Data
|
-44.7 score on a scale
Standard Deviation 47.9
|
-44.7 score on a scale
Standard Deviation 49.6
|
SECONDARY outcome
Timeframe: Up to one month following the pre-implant visit.Population: Of the 9 randomized participants, usable data was only obtained from 3 participants due to protocol deviations.
The Short-Form McGill Pain Questionnaire (SFMPQ) assesses the quality and intensity of pain using 15 descriptors representing sensory (11 items) and affective (4 items) dimensions of pain. Each descriptor is rated on a 4-point intensity scale where 0=none, 1=mild, 2=moderate, and 3=severe. The total scores are calculated by summing the intensity ratings for each of the 15 descriptors (possible score range 0 to 45). Higher scores indicate more severe pain symptoms. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain; better outcome) and positive values indicate worsening (increased pain; worse outcome). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.
Outcome measures
| Measure |
Change of Burst-SCS From Pre-implant
n=3 Participants
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
Change of Sham-SCS From Pre-implant
n=3 Participants
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
|---|---|---|
|
Change in Short-Form McGill Pain Questionnaire (SFMPQ) Score
Baseline - Usable Data
|
17.7 score on a scale
Standard Deviation 9.81
|
17.7 score on a scale
Standard Deviation 9.81
|
|
Change in Short-Form McGill Pain Questionnaire (SFMPQ) Score
Change - Usable Data
|
-11.67 score on a scale
Standard Deviation 9.50
|
-7.67 score on a scale
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: Up to one month following the pre-implant visit.Population: Of the 9 randomized participants, usable data was only obtained from 3 participants due to protocol deviations.
Pain-related disability was assessed using the six-item General Pain Disability Index (PDI) Questionnaire, which measures the degree to which chronic pain disrupts various aspects of daily life. Each item is rated on a 0-10 scale where 0 indicates no disability and 10 indicates total disability in that activity due to pain. The total score ranges from 0 to 60, with higher scores indicating greater pain-related disability. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain-disability) and positive values indicate worsening (increased pain-related disability). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.
Outcome measures
| Measure |
Change of Burst-SCS From Pre-implant
n=3 Participants
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
Change of Sham-SCS From Pre-implant
n=3 Participants
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
|---|---|---|
|
Change in General Pain Disability Index (PDI) Score
Baseline - Usable Data
|
38.3 score on a scale
Standard Deviation 9.02
|
38.3 score on a scale
Standard Deviation 9.02
|
|
Change in General Pain Disability Index (PDI) Score
Change - Usable Data
|
-19.00 score on a scale
Standard Deviation 24.76
|
-20.33 score on a scale
Standard Deviation 24.79
|
SECONDARY outcome
Timeframe: Up to one month following the pre-implant visit.Population: Of the 9 randomized participants, usable data was only obtained from 3 participants due to protocol deviations.
The Brief Pain Inventory-Short Form (BPI-SF) assesses pain severity and pain interference with daily functioning. It includes four items assessing pain severity (worst, least, average, current) and seven items assessing interference (general activity, mood, walking, work, relations, sleep, enjoyment of life). Each item is rated 0 (no pain/interference) to 10 (worst pain/interferes completely). A total composite BPI-SF score was calculated by summing severity (range 0-40) and interference (range 0-70) domains for a total score of 0-110. Higher scores indicate greater pain burden and impairment. Change from baseline was calculated as follow-up score minus baseline score, where negative values indicate improvement. Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.
Outcome measures
| Measure |
Change of Burst-SCS From Pre-implant
n=3 Participants
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
Change of Sham-SCS From Pre-implant
n=3 Participants
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
|---|---|---|
|
Change in Brief Pain Inventory-Short Form (BPI-SF) Score
Baseline - Usable Data
|
7.52 score on a scale
Standard Deviation 2.15
|
7.52 score on a scale
Standard Deviation 2.15
|
|
Change in Brief Pain Inventory-Short Form (BPI-SF) Score
Change - Usable Data
|
-4.12 score on a scale
Standard Deviation 5.11
|
-3.94 score on a scale
Standard Deviation 5.28
|
SECONDARY outcome
Timeframe: Up to one month following the pre-implant visit.Population: Of the 9 randomized participants, usable data was only obtained from 3 participants due to protocol deviations.
MBM was used to assess body areas where chronic pain was experienced and quantify the degree of widespread body pain (i.e. pain centralization). Pain spread was collected by having participants check all areas of the body as outlined on the body map where they felt persistent or recurrent pain. A checked box meant pain was present in that region of the body. The MBM had 35 boxes total participants could check, which were summed together to assess participants' pain. Lower number of checked boxes indicated less widespread pain; higher number of checked boxes indicated more widespread pain. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain areas) and positive values indicate worsening (increased pain areas). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.
Outcome measures
| Measure |
Change of Burst-SCS From Pre-implant
n=3 Participants
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
Change of Sham-SCS From Pre-implant
n=3 Participants
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
|---|---|---|
|
Michigan Body Map (MBM)
Baseline - Usable Data
|
6.67 checked boxes
Standard Deviation 8.08
|
6.67 checked boxes
Standard Deviation 8.08
|
|
Michigan Body Map (MBM)
Change - Usable Data
|
-5.33 checked boxes
Standard Deviation 9.24
|
-5.33 checked boxes
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Up to one month following the pre-implant visit.Population: Of the 9 randomized participants, usable data was only obtained from 3 participants due to protocol deviations.
Pain distribution was assessed using the Widespread Pain Index (WPI) component of the Fibromyalgia Survey Questionnaire (FSQ). The WPI is a 19-item checklist that evaluates the presence of pain or tenderness in specific body regions experienced during the past 7 days. Participants indicate whether they experienced pain in each of 19 anatomical areas including: bilateral shoulder, upper arm, lower arm, hip, upper leg, lower leg, and jaw; plus neck, upper back, lower back, chest, and abdomen. Each painful area receives a score of 1, with the total WPI score ranging from 0 to 19, where higher scores indicate more widespread pain distribution. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain areas) and positive values indicate worsening (increased pain areas). Results were aggregated from all interventions regardless of treatment order and reflect the total diff
Outcome measures
| Measure |
Change of Burst-SCS From Pre-implant
n=3 Participants
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
Change of Sham-SCS From Pre-implant
n=3 Participants
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
|---|---|---|
|
Fibromyalgia Survey Questionnaire (FSQ) - Widespread Pain Index
Baseline - Usable Data
|
3.00 score on a scale
Standard Deviation 2.65
|
3.00 score on a scale
Standard Deviation 2.65
|
|
Fibromyalgia Survey Questionnaire (FSQ) - Widespread Pain Index
Change - Usable Data
|
-2.67 score on a scale
Standard Deviation 2.89
|
-2.00 score on a scale
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: Up to one month following the pre-implant visit.Population: Of the 9 randomized participants, usable data was only obtained from 3 participants due to protocol deviations.
Symptom severity was assessed using the Symptom Severity Index component of the Fibromyalgia Survey Questionnaire (FSQ). The Symptom Severity Index evaluates fibromyalgia-related symptoms through two sections: (1) a three-item scale assessing fatigue, trouble thinking or remembering, and waking up tired over the past week, each rated on a 0-3 scale (0 = no problem, 1 = slight/mild, 2 = moderate, 3 = severe); and (2) a three-item checklist evaluating the presence of lower abdominal pain/cramps, depression, and headache over the past 6 months (0 = absent, 1 = present). The total Symptom Severity Index score ranges from 0 to 12, with higher scores indicating greater symptom severity. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement and positive values indicate worsening. Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.
Outcome measures
| Measure |
Change of Burst-SCS From Pre-implant
n=3 Participants
Burst-SCS: The treatment arm used in the study is burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
Change of Sham-SCS From Pre-implant
n=3 Participants
Sham SCS: The placebo control arm used in the study is sham spinal cord stimulation (sham SCS). The device used to deliver sham SCS is the St. Jude Medical Invisible Trial System.
Pre-implant: Pre-operative baseline assessment prior to implantation of the spinal cord stimulation (SCS) electrode arrays.
|
|---|---|---|
|
Fibromyalgia Survey Questionnaire (FSQ) - Symptom Severity Index
Baseline - Usable Data
|
3.67 score on a scale
Standard Deviation 3.21
|
3.67 score on a scale
Standard Deviation 3.21
|
|
Fibromyalgia Survey Questionnaire (FSQ) - Symptom Severity Index
Change - Usable Data
|
-2.67 score on a scale
Standard Deviation 2.89
|
-2.00 score on a scale
Standard Deviation 3.46
|
Adverse Events
Burst-SCS
Sham-SCS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place