The purpose of this prospective, multi-center, randomized, triple-blind, sham-controlled study with parallel economic evaluation is to test the analgesic superiority of BurstDR-SCS compared to sham stimulation using both traditional patient-reported pain outcome measures and objective physiologic data collected from patient-worn biosensors. The endpoints associated with these objectives will be studied across a follow-up period of 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Spinal Cord Stimulation with a BurstDR-SCS system.
BurstDR-SCS system turned off.
Comprehensive Integrated Pain Program - Interventional Pain Service (CIPP-IPS) (Toronto Western Hospital)
Toronto, Canada
Seacroft Hospital
Leeds, United Kingdom
The Walton Centre
Liverpool, United Kingdom
Guy's and St. Thomas Hospital
London, United Kingdom
Change in overall back pain severity (NRS) at 6 months compared to sham arm
The pain severity endpoint is based on a review of previous RCTs of SCS and a consideration of IMMPACT (Initiative on Methods, Measurement and Pain Assessment in Clinical Trials) and COMET recommendations
Time frame: At 6 Months
Change in a composite of physiologic and behavioral features compared to sham arm leading up to 6 months post-permanent implant
Ability to use composite of physiologic and behavioral features (including data from biosensors) to identify treatment responders and physiological data collected from patient-worn biosensors.
Time frame: At 6 Months
Change in percentage of patients reporting 50% or more reduction in backpain severity (NRS) at 6 months in treatment vs. sham
Time frame: At 6 Months
Change in cumulative proportion of responders for back pain (NRS) in treatment vs. sham
Time frame: At 6 Months
Change in pain-related catastrophizing (Pain Catastrophizing Scale) in treatment vs. sham
The Pain Catastrophizing Scale questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The questionnaire includes thirteen statements describing different thoughts and feelings that may be associated with pain. Using the scale 0-4 (0- not at all; 1- to a slight degree; 2- to a moderate degree; 3- to a great degree; and 4- all the time), the patients are expected to indicate the degree to which they have these thoughts and feelings when they're experiencing pain.
Time frame: At 6 Months
Change in functional disability (Oswestry Disability Index) in treatment vs. sham
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St. Bartholomew Hospital
London, United Kingdom
The Oswestry Disability Index questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. An interpretation of 0% to 20% means minimal disability; 21% to 40% means moderate disability; 41% to 60% means severe disability; 61% to 80% means crippled; and 81%-100% means bed-bound patients.
Time frame: At 6 Months
Change in patient satisfaction (Patient Global Impression of Change) in treatment vs. sham
The Patient Global Impression of Change questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The scale ranges include: 1. No change (or condition has gotten worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better and a definite improvement that has made a real and worthwhile difference 7. A great deal better and a considerable improvement that has made all the difference
Time frame: At 6 Months
Change in health-related quality of life (EQ5D-5L) in treatment vs. sham
The EQ5D-5L questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints and to estimate health-related quality of life and quality-adjusted life years. It is a 5-level version of the EQ5D. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: At 6 Months
Change in health-related quality of life (PROMIS-29+2) in treatment vs. sham
The PROMIS-29+2 questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.
Time frame: At 6 Months
Change in emotional functioning improvement (Patient Health Questionnaire-9) in treatment vs. sham
The Patient Health Questionnaire-9 will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The Patient Health Questionnaire is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. It is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Time frame: At 6 Months
Change in pain interference PROMIS-29+2 domain in treatment vs. sham
The PROMIS-29+2 questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.
Time frame: At 6 Months
Change in social roles and activities PROMIS-29+2 domain in treatment vs. sham
The PROMIS-29+2 questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.
Time frame: At 6 Months
Change in sleep disturbance PROMIS-29+2 domain in treatment vs. sham
The PROMIS-29+2 questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.
Time frame: At 6 Months
Change in on concomitant pain-related medication usage in treatment vs. sham
Importance of keeping pain-related treatments stable (per agreement with physician), including medications, physical therapy, psychotherapy, pain-related treatments (invasive or non-invasive) and interventions.
Time frame: At 6 Months
Change in overall leg pain severity (NRS) at 6 months compared to sham arm in patients who reported baseline chronic leg pain
Time frame: At 6 Months
Change in percentage of patients reporting 50% or more reduction in leg pain severity (NRS) at 6 months in treatment vs. sham in patients who reported baseline chronic leg pain
Time frame: At 6 Months
Change in cumulative proportion of responders for leg pain (NRS) in treatment vs. sham in patients who reported baseline chronic leg pain
Time frame: At 6 Months