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

A Prospective, Randomized, Multi-Center, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation™ AXIUM™ Neurostimulator System in the Treatment of Chronic Pain (ACCURATE Trial)

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).

Study Overview

• Status: Completed
• Conditions: Chronic Lower Limb Pain
• Intervention / Treatment: Device: AXIUM Neurostimulator System; Device: Control Spinal Cord Stimulation Device

Detailed Description

The ACCURATE study is a prospective, randomized, controlled, multicenter clinical trial designed to assess the safety and efficacy of the Spinal Modulation Axium Neurostimulator System as an aid in the management of chronic, intractable pain of the lower limbs, including unilateral or bilateral pain associated with one of the following conditions: Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (also referred to as CRPS Type II).

Enrolled subjects were diagnoses with CRPS or peripheral causalgia; experienced pain for at least six months; and failed to achieve adequate pain relief from at least two prior pharmacologic treatments.

All subjects had a temporary trial neurostimulator (TNS). If the subject was a treatment success at the end of TNS they were scheduled for the fully implantable neurostimulator (INS) implant procedure. If not, subjects were exited from the study.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • HOPE Research - TPC
  • California
    • Aptos, California, United States, 94025
      • Pain Clinic of Monterey Bay
    • Carlsbad, California, United States, 94025
      • Coastal Pain Research
    • Napa, California, United States, 94558
      • Neurovations, Inc.
    • Newport Beach, California, United States, 94025
      • Newport Beach Headache and Pain
    • Rancho Mirage, California, United States, 94025
      • Eisenhower Medical Center
    • Santa Monica, California, United States, 94025
      • Orthopaedic Pain Specialists
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group, Inc.
  • Florida
    • Merritt Island, Florida, United States, 32953
      • Florida Pain Institute
    • Oakland Park, Florida, United States, 33334
      • Holy Cross Hospital Orthopedic Institute
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Drug Studies of America
  • Mississippi
    • Pascagoula, Mississippi, United States, 39581
      • Comprehensive Pain and Rehabilitation
  • Missouri
    • Independence, Missouri, United States, 64055
      • Pain Management Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • HOPE Research - LVSP
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Southeastern Spine Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Pain Centers
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • Center for Pain Relief
    • Huntington, West Virginia, United States, 25702
      • Center for Pain Relief Tri-State

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is male or female between the ages of 22 and 75 years
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Subject has chronic, intractable pain of the lower limb(s) for at least 6 months
4. Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia
5. 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.
6. Subject has failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drugs classes
7. Subject has had stable neurologic function in the past 30 days
8. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation of an active implantable medical device
9. Subject is able to provide written informed consent

Exclusion Criteria:

1. Back pain is the greatest region of pain as measured on the baseline VAS.
2. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
3. Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination
4. Subject is currently involved in medically related litigation, including workers compensation
5. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
6. Subject's pain medication(s) dosage(s) are not stable for at least 30 days
7. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
8. Subject has previously failed spinal cord stimulation therapy
9. 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
10. Subject has pain only within a cervical distribution
11. Subject has cognitive, physical or sensory impairment that, in the opinion of the Investigator, may limit their ability to operate the device
12. Subject currently has an indwelling device that may pose an increased risk of infection
13. Subject currently has an active systemic infection.
14. Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
15. Subject has participated in another clinical investigation within 30 days
16. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the Investigator, precludes participation
17. Subject has been diagnosed with cancer in the past 2 years
18. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
19. Subject is a prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AXIUM Neurostimulator System; 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; Other Names: DRG Stimulation
ACTIVE_COMPARATOR: Control Spinal Cord Stimulation Device; 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; Other Names: SCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positional Effects on Paresthesia Intensities	Positional effects on paresthesia intensities at 3 months in the Control group versus the Treatment Group. This endpoint will compare the difference in paresthesia scores upright and supine between the AXIUM and Control groups. Paresthesia intensity was rated by subjects using a paresthesia intensity rating scale. Subjects rated the intensity of their perception of paresthesia, while upright and supine, on an 11-point numeric rating scale from 0 representing "No feeling" to 10 "Very intense." Perceived paresthesia intensity difference between supine and upright positions was calculated and averaged across each group.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant	Treatment Success is defined as a reduction in pain score greater than or equal to 50 percent 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
Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant	Treatment Success is defined as a reduction in pain score greater than or equal to 50 percent 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").	12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Robyn Capobianco, PhD, Abbott

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (ESTIMATE): August 15, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 03-SMI-2012