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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Utilization of BURSTDR stimulation
Assessing type of CMM, location and frequency.
The Difference in Responders Between Both Groups
Improvement in pain, defined as percentage of patients who report a ≥ 50% decrease on Numeric Rating Scale (NRS).
Time frame: 6 Months
Measure of Composite Responder Rate
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).
Time frame: 6 Months
Numerical Rating Scale (NRS) Relative Change From 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 (%).
Time frame: Baseline to 6 Months
Oswestry Disability Index (ODI) Change From 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.
Time frame: Baseline to 6 Months
Pain Catastrophizing Scale (PCS) Responder Rate
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.
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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 D.C., 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
...and 20 more locations
Time frame: 6 Months
Patient Global Impression of Change (PGIC) Responder Rate
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.
Time frame: 6 Months
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference Relative Change From 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.
Time frame: Baseline to 6 Months
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function Relative Change From 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.
Time frame: Baseline to 6 Months