A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain

NCT01923285 | Completed Results

• 1 other identifier: 03-SMI-2012
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 22

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).

Conditions

Chronic Lower Limb Pain

Outcome Measures

Primary Outcomes (1)

• Primary Composite Endpoint - Treatment Success

  Treatment Success is defined as at least 50% lower limb pain relief (VAS score reduction) at the end of trial phase, received at least 50% lower limb pain relief at the 3-month visit post implant, and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").

  3 months

Secondary Outcomes (1)

• Positional Effects on Paresthesia Intensities

  3 months

Other Outcomes (2)

• Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant

  3 months

• Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant

  12 months

Study Arms (2)

AXIUM Neurostimulator System

EXPERIMENTAL

The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area.

Device: AXIUM Neurostimulator System

Control Spinal Cord Stimulation Device

ACTIVE COMPARATOR

The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.

Device: Control Spinal Cord Stimulation Device

Interventions

AXIUM Neurostimulator System DEVICE

Also known as: DRG Stimulation

AXIUM Neurostimulator System

Control Spinal Cord Stimulation Device DEVICE

Also known as: SCS

Control Spinal Cord Stimulation Device

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female between the ages of 22 and 75 years
• Subject is able and willing to comply with the follow-up schedule and protocol
• Subject has chronic, intractable pain of the lower limb(s) for at least 6 months
• Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia
• Subjects have a minimum Visual Analog Scale (VAS) greater than or equal to 60 mm in the area of greatest pain in the lower limbs.
• Subject has failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drugs classes
• Subject has had stable neurologic function in the past 30 days
• In the opinion of the Investigator, the subject is psychologically appropriate for the implantation of an active implantable medical device
• Subject is able to provide written informed consent

You may not qualify if:

• Back pain is the greatest region of pain as measured on the baseline VAS.
• Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
• Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination
• Subject is currently involved in medically related litigation, including workers compensation
• Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
• Subject's pain medication(s) dosage(s) are not stable for at least 30 days
• Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
• Subject has previously failed spinal cord stimulation therapy
• Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy
• Subject has pain only within a cervical distribution
• Subject has cognitive, physical or sensory impairment that, in the opinion of the Investigator, may limit their ability to operate the device
• Subject currently has an indwelling device that may pose an increased risk of infection
• Subject currently has an active systemic infection.
• Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
• Subject has participated in another clinical investigation within 30 days

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (22)

HOPE Research - TPC

Phoenix, Arizona, 85018, United States

Location

Pain Clinic of Monterey Bay

Aptos, California, 94025, United States

Location

Coastal Pain Research

Carlsbad, California, 94025, United States

Location

Neurovations, Inc.

Napa, California, 94558, United States

Location

Newport Beach Headache and Pain

Newport Beach, California, 94025, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 94025, United States

Location

Orthopaedic Pain Specialists

Santa Monica, California, 94025, United States

Location

IPM Medical Group, Inc.

Walnut Creek, California, 94598, United States

Location

Florida Pain Institute

Merritt Island, Florida, 32953, United States

Location

Holy Cross Hospital Orthopedic Institute

Oakland Park, Florida, 33334, United States

Location

Drug Studies of America

Marietta, Georgia, 30060, United States

Location

Comprehensive Pain and Rehabilitation

Pascagoula, Mississippi, 39581, United States

Location

Pain Management Associates

Independence, Missouri, 64055, United States

Location

HOPE Research - LVSP

Las Vegas, Nevada, 89106, United States

Location

Premier Pain Center

Shrewsbury, New Jersey, 07702, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Southeastern Spine Institute

Mt. Pleasant, South Carolina, 29464, United States

Location

Houston Pain Centers

Houston, Texas, 77030, United States

Location

Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

Center for Pain Relief Tri-State

Huntington, West Virginia, 25702, United States

Location

Related Publications (1)

• Levy RM, Mekhail N, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Scowcroft J, Golovac S, Kapural L, Paicius R, Pope J, Samuel S, McRoberts WP, Schaufele M, Kent AR, Raza A, Deer TR. Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II. J Pain. 2020 Mar-Apr;21(3-4):399-408. doi: 10.1016/j.jpain.2019.08.005. Epub 2019 Sep 5.

  PMID: 31494275 DERIVED

Results Point of Contact

• Title: Robyn Capobianco
• Organization: Abbott

robyn.capobianco@abbott.com

512-286-4274

Study Officials

• Robyn Capobianco, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-11

Locations

US (22)