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Burst Spinal Cord Stimulation (Burst-SCS) Study

Primary Purpose

Pain, Chronic, Failed Back Surgery Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Burst-SCS
Sham SCS
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Burst-SCS, Chronic pain, Spinal cord stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Burst-SCS/sham SCS

Sham SCS/Burst-SCS

Arm Description

First, participants will receive clinically-effective Burst-SCS per their standard of care. 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.

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 clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation.

Outcomes

Primary Outcome Measures

Change in Visual Analog Scale (VAS) score
VAS is a horizontal line 100 millimeters (mm) in length with the word "no pain" and "worst possible pain" with a score between 0 (no pain) to a score of 100 (worst possible pain). The participant marks on the line the point that they feel represents their perception of their current state. The score is determined by measuring in millimeters from the left hand with a total range of 0-100 millimeters. Higher VAS values represent more severe pain.

Secondary Outcome Measures

Change in Short-Form McGill Pain Questionnaire (SFMPQ) score
SFMPQ will be used to describe the quality of pain and has 15 descriptors (11 sensory and 4 affective). Each descriptor is scored by a 4-point intensity scale (0=none to 3=severe) (sensory range 0-45). Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The SFMPQ also includes the Present Pain Intensity (PPI) index (for example (i.e.) the VAS) and an Evaluative Overall Intensity of Total Pain Experience.
Change in General Pain Disability Index (PDI) score
Quality of pain will be described by using this 6-question survey regarding daily living activity. Range is 0 (0 points, completely able to function) to 10 (10 points, totally unable to function). The higher the number score the greater the disability (due to pain).
Change in Brief Pain Inventory-Short Form (BPI-SF) score
Pain severity is measured and includes 9 questions with scores ranging from 0 to 10 with higher scores indicating more severe pain and greater interference with functioning.
Michigan Body Map (MBM)
Pain spread will be collected by having the participants check all areas of their body as outlined on the body map where they have felt persistent or recurrent pain. If there is no pain, the No chronic pain box will be marked. MBM will be used to assess body areas where chronic pain is experienced, and quantify the degree of widespread body pain in the participant (i.e. pain centralization).
Fibromyalgia Survey Questionnaire (FSQ)
Participant is to mark where they have had pain or tenderness on a map of their body (or mark no pain in areas). FSQ in combination with the MBM will be used to assess pain centralization.

Full Information

First Posted
October 23, 2018
Last Updated
June 26, 2023
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03718325
Brief Title
Burst Spinal Cord Stimulation (Burst-SCS) Study
Official Title
Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Failed Back Surgery Syndrome
Keywords
Burst-SCS, Chronic pain, Spinal cord stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Burst-SCS/sham SCS
Arm Type
Other
Arm Description
First, participants will receive clinically-effective Burst-SCS per their standard of care. 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.
Arm Title
Sham SCS/Burst-SCS
Arm Type
Other
Arm Description
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 clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation.
Intervention Type
Device
Intervention Name(s)
Burst-SCS
Intervention Description
The treatment arm used in the study is clinically-effective burst spinal cord stimulation (Burst-SCS). The device used to deliver Burst-SCS is the St. Jude Medical Invisible Trial System.
Intervention Type
Device
Intervention Name(s)
Sham SCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) score
Description
VAS is a horizontal line 100 millimeters (mm) in length with the word "no pain" and "worst possible pain" with a score between 0 (no pain) to a score of 100 (worst possible pain). The participant marks on the line the point that they feel represents their perception of their current state. The score is determined by measuring in millimeters from the left hand with a total range of 0-100 millimeters. Higher VAS values represent more severe pain.
Time Frame
Pre-implant visit, up to approximately 2 weeks
Secondary Outcome Measure Information:
Title
Change in Short-Form McGill Pain Questionnaire (SFMPQ) score
Description
SFMPQ will be used to describe the quality of pain and has 15 descriptors (11 sensory and 4 affective). Each descriptor is scored by a 4-point intensity scale (0=none to 3=severe) (sensory range 0-45). Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The SFMPQ also includes the Present Pain Intensity (PPI) index (for example (i.e.) the VAS) and an Evaluative Overall Intensity of Total Pain Experience.
Time Frame
Pre-implant visit, up to approximately 2 weeks
Title
Change in General Pain Disability Index (PDI) score
Description
Quality of pain will be described by using this 6-question survey regarding daily living activity. Range is 0 (0 points, completely able to function) to 10 (10 points, totally unable to function). The higher the number score the greater the disability (due to pain).
Time Frame
Pre-implant visit, up to approximately 2 weeks
Title
Change in Brief Pain Inventory-Short Form (BPI-SF) score
Description
Pain severity is measured and includes 9 questions with scores ranging from 0 to 10 with higher scores indicating more severe pain and greater interference with functioning.
Time Frame
Pre-implant visit, up to approximately 2 weeks
Title
Michigan Body Map (MBM)
Description
Pain spread will be collected by having the participants check all areas of their body as outlined on the body map where they have felt persistent or recurrent pain. If there is no pain, the No chronic pain box will be marked. MBM will be used to assess body areas where chronic pain is experienced, and quantify the degree of widespread body pain in the participant (i.e. pain centralization).
Time Frame
up to approximately 2 weeks
Title
Fibromyalgia Survey Questionnaire (FSQ)
Description
Participant is to mark where they have had pain or tenderness on a map of their body (or mark no pain in areas). FSQ in combination with the MBM will be used to assess pain centralization.
Time Frame
up to approximately 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Loechli, B.S.
Phone
(734) 647-9052
Email
jloechli@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Lempka, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sana Shaikh, MD
Phone
734-763-5226
Email
skazi@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34854473
Citation
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.
Results Reference
derived

Learn more about this trial

Burst Spinal Cord Stimulation (Burst-SCS) Study

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