Burst Optimized Stimulation Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-08-31

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.

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Stimulation order 1

Stimulations delivered in following order:

1. Standard burst
2. Burst Microdosing 1
3. Burst Microdosing 2

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Stimulation parameters are reprogrammed from original values to study defined ones

Stimulation order 2

Stimulations delivered in following order:

1. Burst Microdosing 1
2. Burst Microdosing 2
3. Standard burst

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Stimulation parameters are reprogrammed from original values to study defined ones

Stimulation order 3

Stimulations delivered in following order:

1. Burst Microdosing 2
2. Standard burst
3. Burst Microdosing 1

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Stimulation parameters are reprogrammed from original values to study defined ones

Interventions

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

Stimulation parameters are reprogrammed from original values to study defined ones

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No