- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718325
Burst Spinal Cord Stimulation (Burst-SCS) Study
June 26, 2023 updated by: Scott Lempka, University of Michigan
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jessica Loechli, B.S.
- Phone Number: (734) 647-9052
- Email: jloechli@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Sana Shaikh, MD
- Phone Number: 734-763-5226
- Email: skazi@med.umich.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Burst-SCS/sham SCS
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.
|
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.
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.
|
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 clinically-effective Burst-SCS per their standard of care.
Study evaluations will be completed prior to and after stimulation.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analog Scale (VAS) score
Time Frame: Pre-implant visit, up to approximately 2 weeks
|
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.
|
Pre-implant visit, up to approximately 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Short-Form McGill Pain Questionnaire (SFMPQ) score
Time Frame: Pre-implant visit, up to approximately 2 weeks
|
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.
|
Pre-implant visit, up to approximately 2 weeks
|
Change in General Pain Disability Index (PDI) score
Time Frame: Pre-implant visit, up to approximately 2 weeks
|
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).
|
Pre-implant visit, up to approximately 2 weeks
|
Change in Brief Pain Inventory-Short Form (BPI-SF) score
Time Frame: Pre-implant visit, up to approximately 2 weeks
|
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.
|
Pre-implant visit, up to approximately 2 weeks
|
Michigan Body Map (MBM)
Time Frame: up to approximately 2 weeks
|
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).
|
up to approximately 2 weeks
|
Fibromyalgia Survey Questionnaire (FSQ)
Time Frame: up to approximately 2 weeks
|
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.
|
up to approximately 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott Lempka, PhD, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2019
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
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 (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 26, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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