Burst Spinal Cord Stimulation (Burst-SCS) Study

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management

Conditions
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Pain, Chronic, Failed Back Surgery Syndrome

Intervention / Treatment
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* Device: Burst-SCS
* Device: Sham SCS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Burst-SCS/sham SCS<br>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<br>* 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.<br>Device: Sham SCS<br>* 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.<br>|
| Other: Sham SCS/Burst-SCS<br>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<br>* 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.<br>Device: Sham SCS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burst-SCS, Chronic pain, Spinal cord stimulation