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

Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain; Refractory Pain; Chronic Low-Back Pain
• Intervention / Treatment: Device: Spinal Cord Stimulation; Other: Conventional Medical Management

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.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85048
      • Barrow Brain & Spine
    • Tucson, Arizona, United States, 85724
      • Banner University Medical Center
  • California
    • Camarillo, California, United States, 93010
      • Spanish Hills Interventional Pain Specialists
    • Carlsbad, California, United States, 92009
      • Coastal Pain & Spinal Diagnostics Medical Group
    • Napa, California, United States, 94558
      • Napa Valley Orthopedic Medical Group
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Connecticut Orthopedic Specialists
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • International Spine, Pain & Performance Center
  • Florida
    • Gainesville, Florida, United States, 32607
      • The Orthopedic Institute
    • Tamarac, Florida, United States, 33321
      • Anesthesia Pain Care Consultants
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83815
      • Axis Spine Center
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Anesthesia Associates
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
    • Indianapolis, Indiana, United States, 45133
      • Goodman Campbell Brain & Spine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Saint Louis Pain Consultants
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Advanced Pain Care
    • Reno, Nevada, United States, 89511
      • Nevada Advanced Pain Specialists
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oregon
    • Tualatin, Oregon, United States, 97062
      • Spinal Diagnostics
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Center for Interventional Pain & Spine
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Carolina Orthopedics and Neurosurgical Associates
  • Texas
    • San Antonio, Texas, United States, 78216
      • Burkhart Research Institute for Orthopaedics
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Spine & Nerve Center of St Francis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Spinal Cord Stimulation (SCS); An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator	Device: Spinal Cord Stimulation; Utilization of BURSTDR stimulation; Other Names: Proclaim XR IPG
Active Comparator: Conventional Medical Management (CMM); 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)	Other: Conventional Medical Management; Assessing type of CMM, location and frequency.; Other Names: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	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.	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: Rumination (e.g. "I can´t stop thinking about how much it hurts"); Magnification (e.g. "I´m afraid that something serious might happen"); 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.	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.	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.	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.	Baseline to 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).	6 Months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: James Yue, MD

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Actual): August 23, 2022
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Spinal Cord Stimulation; Chronic Low Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Neuralgia; Low Back Pain; Pain, Intractable
• Other Study ID Numbers: ABT-CIP-10343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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