Burst Spinal Cord Stimulation (Burst-SCS) Study

• ClinicalTrials.gov Identifier: NCT03718325
• Recruitment Status: Active, not recruiting
• First Posted: October 24, 2018
• Last Update Posted: October 18, 2021
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Scott Lempka, University of Michigan

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.

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

Study Design

• 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
• Actual Study Start Date: March 12, 2019
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

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

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

• 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

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Scott Lempka, PhD; University of Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD013756. doi: 10.1002/14651858.CD013756.pub2. Review.

• Responsible Party: Scott Lempka, Assistant Professor of Biomedical Engineering and Assistant Professor of Anesthesiology, University of Michigan
• ClinicalTrials.gov Identifier: NCT03718325
• Other Study ID Numbers: HUM00147961
• First Posted: October 24, 2018
• Last Update Posted: October 18, 2021
• Last Verified: October 2021

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
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Scott Lempka, University of Michigan:

Burst-SCS; Chronic pain; Spinal cord stimulation

Additional relevant MeSH terms:

Chronic Pain; Failed Back Surgery Syndrome; Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Back Pain