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

NCT04479787 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10343
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 30

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.

Conditions

Chronic Low-Back Pain; Refractory Pain; Neuropathic Pain

Keywords

Chronic Low Back Pain; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Measure of Composite Responder Rate

  6 Months

• Numerical Rating Scale (NRS) Relative Change From Baseline to 6 Months

  Baseline to 6 Months

• Oswestry Disability Index (ODI) Change From Baseline to 6 Months

  Baseline to 6 Months

• Pain Catastrophizing Scale (PCS) Responder Rate

  6 Months

• Patient Global Impression of Change (PGIC) Responder Rate

  6 Months

Study Arms (2)

Spinal Cord Stimulation (SCS)

ACTIVE COMPARATOR

An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator

Device: Spinal Cord Stimulation

Conventional Medical Management (CMM)

ACTIVE COMPARATOR

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

Interventions

Spinal Cord Stimulation DEVICE

Utilization of BURSTDR stimulation

Also known as: Proclaim XR IPG

Spinal Cord Stimulation (SCS)

Conventional Medical Management OTHER

Assessing type of CMM, location and frequency.

Also known as: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.

Conventional Medical Management (CMM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (30)

Barrow Brain & Spine

Phoenix, Arizona, 85048, United States

Location

Banner University Medical Center

Tucson, Arizona, 85724, United States

Location

Spanish Hills Interventional Pain Specialists

Camarillo, California, 93010, United States

Location

Coastal Pain & Spinal Diagnostics Medical Group

Carlsbad, California, 92009, United States

Location

Napa Valley Orthopedic Medical Group

Napa, California, 94558, United States

Location

Connecticut Orthopedic Specialists

Hamden, Connecticut, 06518, United States

Location

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, 20037, United States

Location

The Orthopedic Institute

Gainesville, Florida, 32607, United States

Location

Anesthesia Pain Care Consultants

Tamarac, Florida, 33321, United States

Location

Axis Spine Center

Coeur d'Alene, Idaho, 83815, United States

Location

Chicago Anesthesia Associates

Chicago, Illinois, 60657, United States

Location

Northshore University Health System

Evanston, Illinois, 60201, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Goodman Campbell Brain & Spine

Indianapolis, Indiana, 45133, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Louis Pain Consultants

Chesterfield, Missouri, 63017, United States

Location

Advanced Pain Care

Henderson, Nevada, 89052, United States

Location

Nevada Advanced Pain Specialists

Reno, Nevada, 89511, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Spinal Diagnostics

Tualatin, Oregon, 97062, United States

Location

Center for Interventional Pain & Spine

Exton, Pennsylvania, 19341, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Carolina Orthopedics and Neurosurgical Associates

Spartanburg, South Carolina, 29303, United States

Location

Burkhart Research Institute for Orthopaedics

San Antonio, Texas, 78216, United States

Location

The Spine & Nerve Center of St Francis Hospital

Charleston, West Virginia, 25301, United States

Location

Related Publications (2)

• Deer T, Gilligan C, Falowski S, Desai M, Pilitsis J, Jameson J, Moeschler S, Heros R, Tavel E, Christopher A, Patterson D, Wahezi S, Weisbein J, Antony A, Funk R, Ibrahim M, Lim C, Wilson D, Fishell M, Scarfo K, Dickerson D, Braun E, Buchanan P, Levy RM, Miller N, Duncan J, Xu J, Candido K, Kreiner S, Fahey ME, Yue J. Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial. Neuromodulation. 2023 Oct;26(7):1387-1399. doi: 10.1016/j.neurom.2023.07.009. Epub 2023 Aug 28.

  PMID: 37642628 DERIVED

• 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.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Pain, Intractable; Neuralgia

Interventions

Spinal Cord Stimulation; Physical Therapy Modalities; Dosage Forms; Injections; Acupuncture Therapy; Massage

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Rehabilitation; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Drug Administration Routes; Drug Therapy; Complementary Therapies; Therapy, Soft Tissue; Musculoskeletal Manipulations

Results Point of Contact

• Title: Devyani Nanduri, Sr. Director, Clinical and Regulatory Affairs
• Organization: Abbott

Udoka.okaro@abbott.com

+16698329450

Study Officials

• James Yue, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 21, 2020
• Study Start: July 31, 2020
• Primary Completion: August 23, 2022
• Study Completion: February 26, 2024
• Last Updated: February 3, 2025
• Results First Posted: June 18, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)