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The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain (TRU-BURST)

WithdrawnNot applicableNCT06030284
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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 details

Official title
The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain
Conditions
  • Chronic Intractable Pain
Interventions
  • Device: BurstDR-SCS
  • Device: BurstDR-SCS
Sponsor
Abbott Medical Devices
Start date
2023-04-20
Primary completion
2023-06-01
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Canada, United Kingdom
Total sites listed
5

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
General Inclusion Criteria: 1. Subject must provide written informed consent prior to any clinical investigation-related procedure. 2. Subject is at least 18 years of age or older at the time of enrollment. 3. 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. 4. Subject is willing to undergo a temporary trial of the Abbott neuromodulation SCS system lasting at least 7 days. 5. Subject's average low back pain intensity is ≥ 6 out of 10 on pain numerical rating scale (NRS). 6. 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). 7. Subject's leg pain NRS, if present, is less than or equal to back pain NRS. 8. 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. 9. 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. 10. Subject agrees to report on any healthcare received during the study period. 11. Subject is willing to cooperate with all study requirements including completion of office visits, use of the wearable biosensors during daily activities, regular response to electronic surveys via the iPhone, and use of an at-home medication tracking log for tracking analgesic use and at-home healthcare tracking log (according to schedule outlined in section 6.0 of the protocol). 12. Subject understands that if they are enrolled, they will receive SCS during the trial period before receiving permanent implant. If they continue to a permanent implant, they will be randomly assigned to either sham stimulation or normal stimulation (50% chance) for a period of 6 months. 13. Subject understands that at study completion the i…

Canadian sites (1)

FacilityCityProvince
Comprehensive Integrated Pain Program - Interventional Pain Service (CIPP-IPS) (Toronto Western Hospital)Toronto

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06030284