Burst Optimized Stimulation Study (BOSS)

Abbott

Status: Completed

Conditions: Chronic Pain

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02896361

SJM-CIP-10125

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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29 participants in 3 patient groups

Stimulation order 1

Experimental group

Description:

Stimulations delivered in following order: 1. Standard burst 2. Burst Microdosing 1 3. Burst Microdosing 2

Treatment:

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

Stimulation order 2

Experimental group

Description:

Stimulations delivered in following order: 1. Burst Microdosing 1 2. Burst Microdosing 2 3. Standard burst

Treatment:

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

Stimulation order 3

Experimental group

Description:

Stimulations delivered in following order: 1. Burst Microdosing 2 2. Standard burst 3. Burst Microdosing 1

Treatment:

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