Burst Optimized Stimulation Study

Study Overview
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Brief Summary
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This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.

Detailed Description
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This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms. Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.

Official Title
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Burst Optimized Stimulation Study

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain; Subject has been exclusively using burst stimulation for at least three months; Subject is 18 years of age or older; Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation; Subject agrees not to add or increase pain-related medication from enrollment through the study duration; Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits; Exclusion Criteria: Subject is currently participating in a clinical investigation study that includes an active treatment arm; Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation; Subject has a non SJM neuromodulation device

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation order 1<br>Stimulations delivered in following order: Standard burst Burst Microdosing 1 Burst Microdosing 2 | Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol<br>* Stimulation parameters are reprogrammed from original values to study defined ones<br>|
| Experimental: Stimulation order 2<br>Stimulations delivered in following order: Burst Microdosing 1 Burst Microdosing 2 Standard burst | Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol<br>* Stimulation parameters are reprogrammed from original values to study defined ones<br>|
| Experimental: Stimulation order 3<br>Stimulations delivered in following order: Burst Microdosing 2 Standard burst Burst Microdosing 1 | Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol<br>* Stimulation parameters are reprogrammed from original values to study defined ones<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) for Pain | Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain | assessed every 2 weeks after each intervention, for a total of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D | European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life | assessed every 2 weeks after each intervention, for a total of 6 weeks | 
| Subject Preference | questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were first intervention second intervention third intervention no preference | assessed 6 weeks after baseline at the last follow up visit | 
| Subject Satisfaction | questionnaire on satisfaction with current therapy | assessed every 2 weeks after each intervention, for a total of 6 weeks | 
| Percentage of Participants With Adverse Events |  | assessed over 6 weeks of study participation |