Burst Optimized Stimulation Study

Not Applicable

Completed

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

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Stimulation order 1	Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol	Stimulations delivered in following order: 1. Standard burst 2. Burst Microdosing 1 3. Burst Microdosing 2
Stimulation order 2	Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol	Stimulations delivered in following order: 1. Burst Microdosing 1 2. Burst Microdosing 2 3. Standard burst
Stimulation order 3	Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol	Stimulations delivered in following order: 1. Burst Microdosing 2 2. Standard burst 3. Burst Microdosing 1

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	assessed over 6 weeks of study participation
Subject Preference	assessed 6 weeks after baseline at the last follow up visit	questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were * first intervention * second intervention * third intervention * no preference
EQ-5D	assessed every 2 weeks after each intervention, for a total of 6 weeks	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
Subject Satisfaction	assessed every 2 weeks after each intervention, for a total of 6 weeks	questionnaire on satisfaction with current therapy

Locations (3): NKO Sint-Augustinus
🇧🇪
Antwerpen, Belgium
Klinikum Duisburg GmbH
🇩🇪
Duisburg, North Rhine-Westphalia, Germany
Medizinische Einrichtungen der Universität Düsseldorf
🇩🇪
Düsseldorf, North Rhine-Westphalia, Germany