The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain

Abbott Medical Devices5 sites in 2 countriesApril 20, 2023

ConditionsChronic Intractable Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Intractable Pain
Sponsor: Abbott Medical Devices
Locations: 5
Primary Endpoint: Change in overall back pain severity (NRS) at 6 months compared to sham arm
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 20, 2023

End Date

June 1, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must provide written informed consent prior to any clinical investigation-related procedure.
•Subject is at least 18 years of age or older at the time of enrollment.
•Subject is a potential candidate for trial of an Abbott neuromodulation SCS system for chronic intractable pain and is able to engage in the use of wearables and surveys at least 9 days before commencing their neuromodulation trial period.
•Subject is willing to undergo a temporary trial of the Abbott neuromodulation SCS system lasting at least 7 days.
•Subject's average low back pain intensity is ≥ 6 out of 10 on pain numerical rating scale (NRS).
•Subject has Failed Back Surgery Syndrome (FBSS with persistent low back pain for ≥ 6 months following lumbar spine surgery). OR Subject has not had spine or back surgery AND subject has chronic (at least 6 months), refractory axial low back pain with a neuropathic component, AND subject is not a candidate for spine surgery (recommended to have an orthopedic surgeon review patient's imaging and confirm this).
•Subject's leg pain NRS, if present, is less than or equal to back pain NRS.
•Subject is on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and agrees to not change medication dosage without consulting Investigator.
•Subject agrees not to introduce or change other therapies related to pain without consulting investigator (e.g., physical therapy, psychotherapy, medical interventions). Rescue analgesic medication for chronic pain or for non-index pain (e.g., ibuprofen for an ankle sprain) will be allowed but must be reported.
•Subject agrees to report on any healthcare received during the study period.

Exclusion Criteria

•Subject is not willing to receive implant of a primary cell SCS system.
•Subject is taking more than 50 morphine equivalents of opioid per day.
•Subject has an unstable fusion with FBSS.
•Subject's back and/or leg pain is believed to originate from spinal instability/mechanical pain.
•Subject's back and/or leg pain is believed to originate from existing metal work.
•Subject's low back pain is limited to a single focal pain area that suggests mechanical back pain.
•Subject is currently participating, or intends to participate in another clinical investigation investigating pain management or that could present a confound to this study (per the investigator).
•Subject is pregnant or nursing or subject plans pregnancy during the clinical investigation follow-up period. This includes female who is sexually active and not using a reliable form of birth control or being not surgically sterile or subject is listed as a post-menopausal female within less than 1 year.
•Subject is part of a vulnerable population ( as per section 5.2.2.1 of the study protocol).
•Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.

Outcomes

Primary Outcomes

Change in overall back pain severity (NRS) at 6 months compared to sham arm

Time Frame: At 6 Months

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

Change in a composite of physiologic and behavioral features compared to sham arm leading up to 6 months post-permanent implant

Time Frame: At 6 Months

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.

Secondary Outcomes

Change in percentage of patients reporting 50% or more reduction in backpain severity (NRS) at 6 months in treatment vs. sham(At 6 Months)
Change in health-related quality of life (PROMIS-29+2) in treatment vs. sham(At 6 Months)
Change in social roles and activities PROMIS-29+2 domain in treatment vs. sham(At 6 Months)
Change in pain-related catastrophizing (Pain Catastrophizing Scale) in treatment vs. sham(At 6 Months)
Change in pain interference PROMIS-29+2 domain in treatment vs. sham(At 6 Months)
Change in functional disability (Oswestry Disability Index) in treatment vs. sham(At 6 Months)
Change in patient satisfaction (Patient Global Impression of Change) in treatment vs. sham(At 6 Months)
Change in emotional functioning improvement (Patient Health Questionnaire-9) in treatment vs. sham(At 6 Months)
Change in on concomitant pain-related medication usage in treatment vs. sham(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(At 6 Months)
Change in cumulative proportion of responders for back pain (NRS) in treatment vs. sham(At 6 Months)
Change in health-related quality of life (EQ5D-5L) in treatment vs. sham(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(At 6 Months)
Change in sleep disturbance PROMIS-29+2 domain in treatment vs. sham(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(At 6 Months)