Burst Optimized Stimulation Study (BOSS)

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2610
    • NKO Sint-Augustinus
• Germany
  • North Rhine-Westphalia
    • Duisburg, North Rhine-Westphalia, Germany, 47055
      • Klinikum Duisburg GmbH
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Medizinische Einrichtungen der Universität Düsseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation order 1; 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; Stimulation parameters are reprogrammed from original values to study defined ones
Experimental: Stimulation order 2; 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; Stimulation parameters are reprogrammed from original values to study defined ones
Experimental: Stimulation order 3; 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; Stimulation parameters are reprogrammed from original values to study defined ones

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Medizinische Einrichtungen der Universität Düsseldorf; Klinikum Duisburg GmbH; NKO Sint-Augustinus Antwerpen

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: SJM-CIP-10125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO