Burst Spinal Cord Stimulation (Burst-SCS) Study

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pain, Chronic; Failed Back Surgery Syndrome	Device: Burst-SCS; Device: Sham SCS	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, 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.
Primary Purpose:	Treatment
Official Title:	Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management
Estimated Study Start Date :	January 2019
Estimated Primary Completion Date :	November 2020
Estimated Study Completion Date :	November 2020

Arms and Interventions

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Arm	Intervention/treatment
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.	Device: Burst-SCS; 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.; 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.
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.	Device: Burst-SCS; 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.; 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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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).
3. 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.
4. 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).
5. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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
• Candidates who are willing to limit the introduction of any new medications or treatment modalities for control of chronic pain symptoms during the study

Exclusion Criteria:

• Subjects with prior experience with SCS
• Subjects who are pregnant- as determined by verbal report or chart review
• Subjects currently participating in other therapeutic studies/trials, or completed the studies/trials within the last 30 days
• 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

Contacts and Locations

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Contacts

Contact: Vishwanath Sankarasubramanian, PhD	(734) 647-9052	vishwans@med.umich.edu

Locations

United States, Michigan
University of Michigan	Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sana Shaikh, MD 734-763-5226 skazi@med.umich.edu

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator:	Vishwanath Sankarasubramanian, PhD	University of Michigan

More Information

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Responsible Party:	Vishwanath Sankarasubramanian, Research Fellow, University of Michigan
ClinicalTrials.gov Identifier:	NCT03718325 History of Changes
Other Study ID Numbers:	HUM00147961
First Posted:	October 24, 2018
Last Update Posted:	November 20, 2018
Last Verified:	November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Keywords provided by Vishwanath Sankarasubramanian, University of Michigan:

Burst-SCS; Chronic pain; Spinal cord stimulation

Additional relevant MeSH terms:

Failed Back Surgery Syndrome; Chronic Pain; Back Pain; Pain; Neurologic Manifestations	Nervous System Diseases; Postoperative Complications; Pathologic Processes; Signs and Symptoms