Burst Spinal Cord Stimulation (Burst-SCS) Study

Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03718325

Enrollment

Registered

2018-10-24

Start date

2019-03-12

Completion date

2020-03-10

Last updated

2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic, Failed Back Surgery Syndrome

Keywords

Burst-SCS, Chronic pain, Spinal cord stimulation

Brief summary

Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.

Detailed description

The study was terminated early following the identification of data quality concerns and protocol integrity issues, specifically related to inadequate sham stimulation parameters and compromised participant blinding. Results reporting was significantly delayed due to research-related pauses during the COVID-19 pandemic. Although there were initial plans to resume enrollment and study procedures once feasible, a comprehensive review of the study data identified the protocol integrity concerns, leading to the decision to terminate the study.

Interventions

DEVICEBurst-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.

DEVICESham 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

There will be two research teams. One team will be unblinded (e.g. clinical care provider/company representative, study coordinator) and will perform stimulator programming/adjustment, and the other team will be blinded (e.g. research personnel) and will perform clinical testing and collect study outcome measures.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men or women with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with any of the following: failed back surgery syndrome and intractable low back and leg pain, and for whom Burst-SCS has been recommended as a treatment option * Candidates who can speak, read, and understand English

Exclusion criteria

* Subjects who are pregnant- as determined by verbal report or chart review * Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principal investigator * Subjects who are unable or unwilling to cooperate with clinical testing * Subjects having any impairment, activity or situation that, in the judgement of the study coordinator or PI, would prevent satisfactory completion of the study protocol

Design outcomes

Primary

Measure	Time frame	Description
Change in Visual Analog Scale (VAS) Score	Up to one month following the pre-implant visit.	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.

Secondary

Measure	Time frame	Description
Change in General Pain Disability Index (PDI) Score	Up to one month following the pre-implant visit.	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.
Change in Brief Pain Inventory-Short Form (BPI-SF) Score	Up to one month following the pre-implant visit.	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.
Change in Short-Form McGill Pain Questionnaire (SFMPQ) Score	Up to one month following the pre-implant visit.	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.
Fibromyalgia Survey Questionnaire (FSQ) - Widespread Pain Index	Up to one month following the pre-implant visit.	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
Fibromyalgia Survey Questionnaire (FSQ) - Symptom Severity Index	Up to one month following the pre-implant visit.	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.
Michigan Body Map (MBM)	Up to one month following the pre-implant visit.	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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	4
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.	5
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.	3
Total	12

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
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

Characteristic	Burst-SCS/Sham-SCS	Sham-SCS/Burst-SCS	Un-randomized Participants	Total
Age, Continuous	50.5 years STANDARD_DEVIATION 10.1	51.8 years STANDARD_DEVIATION 8.64	48.7 years STANDARD_DEVIATION 6.81	50.6 years STANDARD_DEVIATION 8.06
Brief Pain Inventory-Short Form (BPI-SF) Score	6.84 score on a scale STANDARD_DEVIATION 0.71	6.59 score on a scale STANDARD_DEVIATION 2.19	6.12 score on a scale STANDARD_DEVIATION 1.36	6.56 score on a scale STANDARD_DEVIATION 1.52
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants	5 Participants	3 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Fibromyalgia Survey Questionnaire (FSQ) - Symptom Severity Index	7.00 score on a scale STANDARD_DEVIATION 2.16	3.20 score on a scale STANDARD_DEVIATION 1.92	5.67 score on a scale STANDARD_DEVIATION 0.58	5.08 score on a scale STANDARD_DEVIATION 2.39
Fibromyalgia Survey Questionnaire (FSQ) - Widespread Pain Index	3.25 score on a scale STANDARD_DEVIATION 3.86	3.8 score on a scale STANDARD_DEVIATION 2.05	5.67 score on a scale STANDARD_DEVIATION 2.52	4.08 score on a scale STANDARD_DEVIATION 2.78
General Pain Disability Index (PDI) Score	36.3 score on a scale STANDARD_DEVIATION 5.62	30.6 score on a scale STANDARD_DEVIATION 11.9	24.7 score on a scale STANDARD_DEVIATION 17	31 score on a scale STANDARD_DEVIATION 11.6
Michigan Body Map (MBM)	4.5 checked boxes STANDARD_DEVIATION 5.69	7.2 checked boxes STANDARD_DEVIATION 5.45	11.3 checked boxes STANDARD_DEVIATION 7.77	7.33 checked boxes STANDARD_DEVIATION 6.14
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	4 Participants	5 Participants	3 Participants	12 Participants
Region of Enrollment United States	4 Participants	5 Participants	3 Participants	12 Participants
Sex: Female, Male Female	3 Participants	2 Participants	1 Participants	6 Participants
Sex: Female, Male Male	1 Participants	3 Participants	2 Participants	6 Participants
Short-Form McGill Pain Questionnaire (SFMPQ) Score	26 score on a scale STANDARD_DEVIATION 11.2	19.6 score on a scale STANDARD_DEVIATION 10.7	22.7 score on a scale STANDARD_DEVIATION 1.53	22.5 score on a scale STANDARD_DEVIATION 9.2
Visual Analog Scale (VAS) Score	71.2 score on a scale STANDARD_DEVIATION 9.6	78.4 score on a scale STANDARD_DEVIATION 15	83.7 score on a scale STANDARD_DEVIATION 5.2	76.8 score on a scale STANDARD_DEVIATION 12

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 9	0 / 9
other Total, other adverse events	0 / 9	0 / 9
serious Total, serious adverse events	0 / 9	0 / 9

Outcome results

Primary

Change in Visual Analog Scale (VAS) Score

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.

Time frame: Up to one month following the pre-implant visit.