Clinical trial NCT04479787: Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
Official title: Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-Back Pain
Refractory Pain
Neuropathic Pain
Keywords: Chronic Low Back Pain
Spinal Cord Stimulation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with conventional medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.

Detailed description: A prospective, multi-center, randomized, controlled clinical study with an optional crossover component. The study is designed to evaluate the efficacy of BurstDR SCS in the treatment of chronic axial low back pain with a neuropathic component, compared to conventional medical management (CMM).

Subjects will be followed in-clinic at 1,3, 6, 9, 12, 18 and 24 months and via phone call or optional clinic visit at 15- and 21-months. The primary endpoint will be assessed at the 6-month follow-up visit. Upon completion of the 6-month follow-up visit, subjects who are dissatisfied with therapy and receiving inadequate improvement with their treatment assignment will be allowed to cross-over to the other treatment arm, if desired.

The study will enroll up to 270 patients at up to 30 sites. Subjects will be randomized in a 3:2 fashion to yield approximately 200 evaluable subjects for the primary endpoint analysis.

Eligibility criteria: Inclusion Criteria:

1. Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.
2. Age ≥ 18 years
3. Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery
4. Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care
5. Patient has not had spine surgery for back or leg pain
6. Patient is a candidate for spinal cord stimulation
7. Low back pain ≥ 6 on Numerical Rating Scale
8. Oswestry Disability Index score of ≥ 30%
9. Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan

Exclusion Criteria:

1. Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.
2. Primary complaint of leg pain, or leg pain is greater than back pain
3. Back pain is due to any of the following:

   * spinal instability defined as \> 2 mm translation on radiographic imaging
   * visceral causes (e.g., endometriosis or fibroids)
   * vascular causes (e.g., aortic aneurysm)
   * spinal infection (e.g., osteomyelitis)
   * inflammation or damage to the spinal cord (e.g. arachnoiditis or syringomyelia)
   * tumor or spinal metastases
4. Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g. neck pain, shoulder pain)
5. Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)
6. Neurological deficit (e.g. foot drop)
7. Prior lumbar spine surgery or sacroiliac joint fusion
8. Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days
9. Patient is bed bound
10. Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
11. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement
12. Known allergic reaction to implanted materials
13. Severe scoliotic deformity (\>11 degrees in thoracic or lumbar spine)
14. Patient has a history of, or existing intrathecal drug pump
15. Patient has previous experience with neuromodulation devices, including a failed trial
16. BMI \> 40
17. Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by Abbott personnel
18. 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 results.
19. Failed psychological evaluation
20. Suspicion or evidence of untreated mental illness, or substance abuse
21. Patient demonstrated 2 or more Waddell's signs of nonorganic behavior
22. Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
23. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

    * Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to enrollment/baseline visit per site standard test.

Primary outcomes:
measure: The Difference in Responders Between Both Groups
timeFrame: 6 Months
Secondary outcomes:
measure: Measure of Composite Responder Rate
timeFrame: 6 Months
measure: Numerical Rating Scale (NRS) Relative Change From Baseline to 6 Months
timeFrame: Baseline to 6 Months
measure: Oswestry Disability Index (ODI) Change From Baseline to 6 Months
timeFrame: Baseline to 6 Months
measure: Pain Catastrophizing Scale (PCS) Responder Rate
timeFrame: 6 Months
measure: Patient Global Impression of Change (PGIC) Responder Rate
timeFrame: 6 Months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference Relative Change From Baseline to 6 Months
timeFrame: Baseline to 6 Months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function Relative Change From Baseline to 6 Months
timeFrame: Baseline to 6 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Brain & Spine
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Camarillo
country: United States
facility: Spanish Hills Interventional Pain Specialists
state: California
city: Carlsbad
country: United States
facility: Coastal Pain & Spinal Diagnostics Medical Group
state: California
city: Napa
country: United States
facility: Napa Valley Orthopedic Medical Group
state: California
city: Hamden
country: United States
facility: Connecticut Orthopedic Specialists
state: Connecticut
city: Washington
country: United States
facility: International Spine, Pain & Performance Center
state: District of Columbia
city: Gainesville
country: United States
facility: The Orthopedic Institute
state: Florida
city: Tamarac
country: United States
facility: Anesthesia Pain Care Consultants
state: Florida
city: Coeur d'Alene
country: United States
facility: Axis Spine Center
state: Idaho
city: Chicago
country: United States
facility: Chicago Anesthesia Associates
state: Illinois
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Indianapolis
country: United States
facility: Goodman Campbell Brain & Spine
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: Saint Louis Pain Consultants
state: Missouri
city: Henderson
country: United States
facility: Advanced Pain Care
state: Nevada
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Tualatin
country: United States
facility: Spinal Diagnostics
state: Oregon
city: Exton
country: United States
facility: Center for Interventional Pain & Spine
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Carolina Orthopedics and Neurosurgical Associates
state: South Carolina
city: San Antonio
country: United States
facility: Burkhart Research Institute for Orthopaedics
state: Texas
city: Charleston
country: United States
facility: The Spine & Nerve Center of St Francis Hospital
state: West Virginia
Study officials:
name: James Yue, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.