Burst Optimized Stimulation Study

Chronic Pain Clinical Trial

— BOSS  

Official title:

Burst Optimized Stimulation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896361
• Other study ID #: SJM-CIP-10125
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
Belgium	NKO Sint-Augustinus	Antwerpen
Germany	Klinikum Duisburg GmbH	Duisburg	North Rhine-Westphalia
Germany	Medizinische Einrichtungen der Universität Düsseldorf	Düsseldorf	North Rhine-Westphalia

Sponsors (4)

Lead Sponsor	Collaborator
Abbott Medical Devices	Klinikum Duisburg GmbH, Medizinische Einrichtungen der Universität Düsseldorf, NKO Sint-Augustinus Antwerpen

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Subject Satisfaction	questionnaire on satisfaction with current therapy	assessed every 2 weeks after each intervention, for a total of 6 weeks
Secondary	Incidence of Adverse Events		assessed over 6 weeks of study participation