Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
Primary Purpose
Chronic Low-Back Pain, Refractory Pain, Neuropathic Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulation
Conventional Medical Management
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-Back Pain focused on measuring Chronic Low Back Pain, Spinal Cord Stimulation
Eligibility Criteria
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.
Sites / Locations
- Barrow Brain & Spine
- Banner University Medical Center
- Spanish Hills Interventional Pain Specialists
- Coastal Pain & Spinal Diagnostics Medical Group
- Napa Valley Orthopedic Medical Group
- Connecticut Orthopedic Specialists
- International Spine, Pain & Performance Center
- The Orthopedic Institute
- Anesthesia Pain Care Consultants
- Axis Spine Center
- Chicago Anesthesia Associates
- Northshore University Health System
- Indiana Spine Group
- Goodman Campbell Brain & Spine
- Kansas University Medical Center
- Brigham & Women's Hospital
- Mayo Clinic
- Saint Louis Pain Consultants
- Advanced Pain Care
- Nevada Advanced Pain Specialists
- Albany Medical Center
- Montefiore Medical Center
- The Cleveland Clinic Foundation
- Summit Spine
- Spinal Diagnostics
- Center for Interventional Pain & Spine
- Rhode Island Hospital
- Clinical Trials of South Carolina
- Carolina Orthopedics and Neurosurgical Associates
- Burkhart Research Institute for Orthopaedics
- The Spine & Nerve Center of St Francis Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Spinal Cord Stimulation (SCS)
Conventional Medical Management (CMM)
Arm Description
An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator
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)
Outcomes
Primary Outcome Measures
The difference in responders between both groups
Improvement in pain, defined as a ≥ 50% decrease on NRS
Secondary Outcome Measures
Comparison between both groups
Change in ODI from baseline, and the percentage of change in NRS from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04479787
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-Back Pain, Refractory Pain, Neuropathic Pain
Keywords
Chronic Low Back Pain, Spinal Cord Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal Cord Stimulation (SCS)
Arm Type
Active Comparator
Arm Description
An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator
Arm Title
Conventional Medical Management (CMM)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation
Other Intervention Name(s)
Proclaim XR IPG
Intervention Description
Utilization of BURSTDR stimulation
Intervention Type
Other
Intervention Name(s)
Conventional Medical Management
Other Intervention Name(s)
Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.
Intervention Description
Assessing type of CMM, location and frequency.
Primary Outcome Measure Information:
Title
The difference in responders between both groups
Description
Improvement in pain, defined as a ≥ 50% decrease on NRS
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Comparison between both groups
Description
Change in ODI from baseline, and the percentage of change in NRS from baseline
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Yue, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Brain & Spine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85048
Country
United States
Facility Name
Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Spanish Hills Interventional Pain Specialists
City
Camarillo
State/Province
California
ZIP/Postal Code
93010
Country
United States
Facility Name
Coastal Pain & Spinal Diagnostics Medical Group
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Napa Valley Orthopedic Medical Group
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Connecticut Orthopedic Specialists
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
International Spine, Pain & Performance Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
The Orthopedic Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Anesthesia Pain Care Consultants
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Axis Spine Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83815
Country
United States
Facility Name
Chicago Anesthesia Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Northshore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Goodman Campbell Brain & Spine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
45133
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Louis Pain Consultants
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Advanced Pain Care
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Nevada Advanced Pain Specialists
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Summit Spine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Spinal Diagnostics
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Center for Interventional Pain & Spine
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Carolina Orthopedics and Neurosurgical Associates
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Burkhart Research Institute for Orthopaedics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78216
Country
United States
Facility Name
The Spine & Nerve Center of St Francis Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34854473
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.
Results Reference
derived
Learn more about this trial
Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
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