Burst Spinal Cord Stimulation (Burst-SCS) Study

Not Applicable

Recruiting

• Conditions: Failed Back Surgery Syndrome; Pain, Chronic
• Interventions: Device: Burst-SCS; Device: Sham SCS

• Registration Number: NCT03718325
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Study Start: 2019-03-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Burst-SCS/sham SCS	Burst-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.
Sham SCS/Burst-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.
Burst-SCS/sham 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.
Sham SCS/Burst-SCS	Sham 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.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) score	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

Name	Time	Method
Change in General Pain Disability Index (PDI) score	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).
Change in Brief Pain Inventory-Short Form (BPI-SF) score	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.
Change in Short-Form McGill Pain Questionnaire (SFMPQ) score	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.
Michigan Body Map (MBM)	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).
Fibromyalgia Survey Questionnaire (FSQ)	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States