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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923285
Recruitment Status : Completed
First Posted : August 15, 2013
Results First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Lower Limb Pain Device: AXIUM Neurostimulator System Device: Control Spinal Cord Stimulation Device Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : August 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: SCS


Outcome Measures
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Primary Outcome Measures :
  1. Primary Composite Endpoint - Treatment Success [ Time Frame: 3 months ]
    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").


Secondary Outcome Measures :
  1. Positional Effects on Paresthesia Intensities [ Time Frame: 3 months ]
    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.


Other Outcome Measures:
  1. Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant [ Time Frame: 3 months ]
    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").

  2. Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant [ Time Frame: 12 months ]
    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").


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923285


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Robyn Capobianco, PhD Abbott
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01923285    
Other Study ID Numbers: 03-SMI-2012
First Posted: August 15, 2013    Key Record Dates
Results First Posted: November 24, 2020
Last Update Posted: November 24, 2020
Last Verified: November 2020