Clinical trial NCT06030284: The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain (TRU-BURST)
Official title: The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Intractable Pain
Keywords: ABT-CIP-10453
Spinal Cord Stimulation
TRU-BURST
BurstDR-SCS
FBSS
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 implanted SCS system will not be explanted or removed as part of the study, regardless of study outcomes.

General Exclusion Criteria:

1. Subject is not willing to receive implant of a primary cell SCS system.
2. Subject is taking more than 50 morphine equivalents of opioid per day.
3. Subject has an unstable fusion with FBSS.
4. Subject's back and/or leg pain is believed to originate from spinal instability/mechanical pain.
5. Subject's back and/or leg pain is believed to originate from existing metal work.
6. Subject's low back pain is limited to a single focal pain area that suggests mechanical back pain.
7. 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).
8. 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.
9. Subject is part of a vulnerable population ( as per section 5.2.2.1 of the study protocol).
10. 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.
11. Subject has chronic widespread pain or confounding pain that will interfere with reporting of low back and leg pain (e.g. consider any chronic pain in the upper back, neck, head, face, shoulders, arms, or chronic headaches)
12. Subject has previously had permanent implantation of another SCS, DRG stimulation, or intrathecal drug delivery system or is scheduled to receive such system in a timeframe that would overlap with this study.
13. Subject has already participated in a SCS trial period before enrolling in the study and is now waiting for their permanent implantation.
14. Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
15. Subject has a skin condition that could be exacerbated by use of the wearable biosensors (e.g., skin allergy to metals, plastics), as determined by the investigator.
16. Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
17. Subject is bedridden.
18. Subject has life expectancy of less than 12 months.
19. Subject has a current diagnosis of a progressive neurological disorder as determined by the investigator. (e.g. multiple sclerosis, Huntington's disease)
20. Subject has a bleeding diathesis such as coagulopathy or thrombocytopenia
21. Subject has a current diagnosis of a coagulation disorder or uncontrolled diabetes mellitus.
22. Subject is immunocompromised and at an increased risk for infection
23. Subject has a systemic infection or local infection
24. Subject has regular intake of systemic steroids (except inhaled steroids used to treat asthma)
25. BMI \> 40.
26. Subject has an active malignant disease or history of cancer requiring treatment in the last 12 months.
27. Evidence of an active disruptive psychological or psychiatric disorder or social condition as determined by the investigator.
28. Suspicion or evidence of untreated mental illness, substance abuse, or drug-seeking behavior.
29. Subject is involved in an injury claim under active litigation that involves back or leg pain/injury or is receiving or planning to receive worker's compensation payments related to back or leg pain.
30. Subject has a diagnosis of spondylolisthesis or scoliosis

Protocol-Specific Screening Exclusion Criteria:

1. Urine pregnancy test.

Primary outcomes:
measure: Change in overall back pain severity (NRS) at 6 months compared to sham arm
timeFrame: At 6 Months
measure: Change in a composite of physiologic and behavioral features compared to sham arm leading up to 6 months post-permanent implant
timeFrame: At 6 Months
Secondary outcomes:
measure: Change in percentage of patients reporting 50% or more reduction in backpain severity (NRS) at 6 months in treatment vs. sham
timeFrame: At 6 Months
measure: Change in cumulative proportion of responders for back pain (NRS) in treatment vs. sham
timeFrame: At 6 Months
measure: Change in pain-related catastrophizing (Pain Catastrophizing Scale) in treatment vs. sham
timeFrame: At 6 Months
measure: Change in functional disability (Oswestry Disability Index) in treatment vs. sham
timeFrame: At 6 Months
measure: Change in patient satisfaction (Patient Global Impression of Change) in treatment vs. sham
timeFrame: At 6 Months
measure: Change in health-related quality of life (EQ5D-5L) in treatment vs. sham
timeFrame: At 6 Months
measure: Change in health-related quality of life (PROMIS-29+2) in treatment vs. sham
timeFrame: At 6 Months
measure: Change in emotional functioning improvement (Patient Health Questionnaire-9) in treatment vs. sham
timeFrame: At 6 Months
measure: Change in pain interference PROMIS-29+2 domain in treatment vs. sham
timeFrame: At 6 Months
measure: Change in social roles and activities PROMIS-29+2 domain in treatment vs. sham
timeFrame: At 6 Months
measure: Change in sleep disturbance PROMIS-29+2 domain in treatment vs. sham
timeFrame: At 6 Months
measure: Change in on concomitant pain-related medication usage in treatment vs. sham
timeFrame: At 6 Months
measure: Change in overall leg pain severity (NRS) at 6 months compared to sham arm in patients who reported baseline chronic leg pain
timeFrame: At 6 Months
measure: 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
timeFrame: At 6 Months
measure: Change in cumulative proportion of responders for leg pain (NRS) in treatment vs. sham in patients who reported baseline chronic leg pain
timeFrame: At 6 Months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Comprehensive Integrated Pain Program - Interventional Pain Service (CIPP-IPS) (Toronto Western Hospital)
city: Leeds
country: United Kingdom
facility: Seacroft Hospital
city: Liverpool
country: United Kingdom
facility: The Walton Centre
city: London
country: United Kingdom
facility: Guy's and St. Thomas Hospital
city: London
country: United Kingdom
facility: St. Bartholomew Hospital
Study officials:
name: Dr. Stefano Palmisani
role: PRINCIPAL_INVESTIGATOR
References: