Burst Spinal Cord Stimulation (Burst-SCS) Study

Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Chronic; Failed Back Surgery Syndrome
• Intervention / Treatment: Device: Sham SCS; Device: Burst-SCS

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: 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.; Device: 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.
Other: 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.	Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to one month following the pre-implant visit.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Scott Lempka, PhD, University of Michigan

Publications and helpful links

General Publications

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Chronic pain; Spinal cord stimulation; Burst-SCS
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: HUM00147961; UL1TR002240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No