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Burst Optimized Stimulation Study (BOSS)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NKO Sint-Augustinus
  • Klinikum Duisburg GmbH
  • Medizinische Einrichtungen der Universität Düsseldorf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stimulation order 1

Stimulation order 2

Stimulation order 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Subject Preference
questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were first intervention second intervention third intervention no preference
Subject Satisfaction
questionnaire on satisfaction with current therapy
Percentage of Participants With Adverse Events

Full Information

First Posted
September 1, 2016
Last Updated
May 17, 2019
Sponsor
Abbott Medical Devices
Collaborators
Medizinische Einrichtungen der Universität Düsseldorf, Klinikum Duisburg GmbH, NKO Sint-Augustinus Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT02896361
Brief Title
Burst Optimized Stimulation Study
Acronym
BOSS
Official Title
Burst Optimized Stimulation Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
Medizinische Einrichtungen der Universität Düsseldorf, Klinikum Duisburg GmbH, NKO Sint-Augustinus Antwerpen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stimulation order 1
Arm Type
Experimental
Arm Description
Stimulations delivered in following order: Standard burst Burst Microdosing 1 Burst Microdosing 2
Arm Title
Stimulation order 2
Arm Type
Experimental
Arm Description
Stimulations delivered in following order: Burst Microdosing 1 Burst Microdosing 2 Standard burst
Arm Title
Stimulation order 3
Arm Type
Experimental
Arm Description
Stimulations delivered in following order: Burst Microdosing 2 Standard burst Burst Microdosing 1
Intervention Type
Device
Intervention Name(s)
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol
Intervention Description
Stimulation parameters are reprogrammed from original values to study defined ones
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for Pain
Description
Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain
Time Frame
assessed every 2 weeks after each intervention, for a total of 6 weeks
Secondary Outcome Measure Information:
Title
EQ-5D
Description
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
Time Frame
assessed every 2 weeks after each intervention, for a total of 6 weeks
Title
Subject Preference
Description
questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were first intervention second intervention third intervention no preference
Time Frame
assessed 6 weeks after baseline at the last follow up visit
Title
Subject Satisfaction
Description
questionnaire on satisfaction with current therapy
Time Frame
assessed every 2 weeks after each intervention, for a total of 6 weeks
Title
Percentage of Participants With Adverse Events
Time Frame
assessed over 6 weeks of study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lalit Venkatesan, Ph.D.
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
NKO Sint-Augustinus
City
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Klinikum Duisburg GmbH
City
Duisburg
State/Province
North Rhine-Westphalia
ZIP/Postal Code
47055
Country
Germany
Facility Name
Medizinische Einrichtungen der Universität Düsseldorf
City
Düsseldorf
State/Province
North Rhine-Westphalia
ZIP/Postal Code
40225
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Burst Optimized Stimulation Study

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