Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)

Not Applicable

Completed

Conditions: Refractory Pain
Chronic Low-Back Pain
Neuropathic Pain

Interventions: Device: Spinal Cord Stimulation
Other: Conventional Medical Management

Registration Number: NCT04479787

Lead Sponsor: Abbott Medical Devices

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 270

Inclusion Criteria

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

Exclusion Criteria

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.
Primary complaint of leg pain, or leg pain is greater than back pain
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
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)
Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)
Neurological deficit (e.g. foot drop)
Prior lumbar spine surgery or sacroiliac joint fusion
Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days
Patient is bed bound
Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement
Known allergic reaction to implanted materials
Severe scoliotic deformity (>11 degrees in thoracic or lumbar spine)
Patient has a history of, or existing intrathecal drug pump
Patient has previous experience with neuromodulation devices, including a failed trial
BMI > 40
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
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.
Failed psychological evaluation
Suspicion or evidence of untreated mental illness, or substance abuse
Patient demonstrated 2 or more Waddell's signs of nonorganic behavior
Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation (SCS)	Spinal Cord Stimulation	An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator
Conventional Medical Management (CMM)	Conventional Medical Management	CMM consists of an array of therapies including, but not limited to structured physical therapy, medications, injections, and complementary and alternative medicine (e.g. acupuncture, massage therapy)

Primary Outcome Measures

Name	Time	Method
The Difference in Responders Between Both Groups	6 Months	Improvement in pain, defined as percentage of patients who report a ≥ 50% decrease on Numeric Rating Scale (NRS).

Secondary Outcome Measures

Name	Time	Method
Measure of Composite Responder Rate	6 Months	Composite Responder rate describes percentage of patients who responded on NRS OR ODI improvements (percentage of patients who report at least ≥13 change on ODI from baseline OR a ≥ 50% decrease in NRS from baseline).
Numerical Rating Scale (NRS) Relative Change From Baseline to 6 Months	Baseline to 6 Months	The numeric rating scale (NRS) is a verbal or written determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain (the worst pain imaginable). Lower scores indicate pain reduction. The data is expressed as relative change (%).
Oswestry Disability Index (ODI) Change From Baseline to 6 Months	Baseline to 6 Months	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. Lower scores indicate less disability.
Pain Catastrophizing Scale (PCS) Responder Rate	6 Months	The Pain Catastrophizing Scale questionnaire is a three part question that measures three pain domains: 1. Rumination (e.g. "I can´t stop thinking about how much it hurts") 2. Magnification (e.g. "I´m afraid that something serious might happen") 3. Helplessness (e.g. "There is nothing I can do to reduce the intensity of my pain"). 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 13 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. Lower scores indicate less catastrophizing thoughts.
Patient Global Impression of Change (PGIC) Responder Rate	6 Months	PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." The percentage of patients who reported "very much improved," or "much improved," are presented.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference Relative Change From Baseline to 6 Months	Baseline to 6 Months	The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome). Pain Interferences: Normal: \<55; Mild: 55 - 60; Moderate: 60 -70; and Severe: \>70.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function Relative Change From Baseline to 6 Months	Baseline to 6 Months	The PROMIS-29 physical function sub-scale includes 4 questions. The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome). Physical function- Normal: \>45; Mild: 40 - 45; Moderate: 30 - 40; and Severe: \>30.

Trial Locations

Locations (30): Goodman Campbell Brain & Spine
🇺🇸
Indianapolis, Indiana, United States
Barrow Brain & Spine
🇺🇸
Phoenix, Arizona, United States
Banner University Medical Center
🇺🇸
Tucson, Arizona, United States
Spanish Hills Interventional Pain Specialists
🇺🇸
Camarillo, California, United States
Coastal Pain & Spinal Diagnostics Medical Group
🇺🇸
Carlsbad, California, United States
Napa Valley Orthopedic Medical Group
🇺🇸
Napa, California, United States
Connecticut Orthopedic Specialists
🇺🇸
Hamden, Connecticut, United States
International Spine, Pain & Performance Center
🇺🇸
Washington, District of Columbia, United States
The Orthopedic Institute
🇺🇸
Gainesville, Florida, United States
Anesthesia Pain Care Consultants
🇺🇸
Tamarac, Florida, United States
Axis Spine Center
🇺🇸
Coeur d'Alene, Idaho, United States
Chicago Anesthesia Associates
🇺🇸
Chicago, Illinois, United States
Northshore University Health System
🇺🇸
Evanston, Illinois, United States
Indiana Spine Group
🇺🇸
Carmel, Indiana, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Saint Louis Pain Consultants
🇺🇸
Chesterfield, Missouri, United States
Advanced Pain Care
🇺🇸
Henderson, Nevada, United States
Nevada Advanced Pain Specialists
🇺🇸
Reno, Nevada, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Spinal Diagnostics
🇺🇸
Tualatin, Oregon, United States
Center for Interventional Pain & Spine
🇺🇸
Exton, Pennsylvania, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States
Clinical Trials of South Carolina
🇺🇸
Charleston, South Carolina, United States
Carolina Orthopedics and Neurosurgical Associates
🇺🇸
Spartanburg, South Carolina, United States
Burkhart Research Institute for Orthopaedics
🇺🇸
San Antonio, Texas, United States
The Spine & Nerve Center of St Francis Hospital
🇺🇸
Charleston, West Virginia, United States