Clinical trial NCT01923285: A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lower Limb Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-08-15
Enrollment: 152
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Primary Composite Endpoint - Treatment Success
timeFrame: 3 months
Secondary outcomes:
measure: Positional Effects on Paresthesia Intensities
timeFrame: 3 months
Other outcomes:
measure: Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant
timeFrame: 3 months
measure: Primary Composite Endpoint - Treatment Success for Only Those Subjects With a Permanent Implant
timeFrame: 12 months
Locations:
city: Phoenix
country: United States
facility: HOPE Research - TPC
state: Arizona
city: Aptos
country: United States
facility: Pain Clinic of Monterey Bay
state: California
city: Carlsbad
country: United States
facility: Coastal Pain Research
state: California
city: Napa
country: United States
facility: Neurovations, Inc.
state: California
city: Newport Beach
country: United States
facility: Newport Beach Headache and Pain
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Santa Monica
country: United States
facility: Orthopaedic Pain Specialists
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group, Inc.
state: California
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Oakland Park
country: United States
facility: Holy Cross Hospital Orthopedic Institute
state: Florida
city: Marietta
country: United States
facility: Drug Studies of America
state: Georgia
city: Pascagoula
country: United States
facility: Comprehensive Pain and Rehabilitation
state: Mississippi
city: Independence
country: United States
facility: Pain Management Associates
state: Missouri
city: Las Vegas
country: United States
facility: HOPE Research - LVSP
state: Nevada
city: Shrewsbury
country: United States
facility: Premier Pain Center
state: New Jersey
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Southeastern Spine Institute
state: South Carolina
city: Houston
country: United States
facility: Houston Pain Centers
state: Texas
city: Charleston
country: United States
facility: Center for Pain Relief
state: West Virginia
city: Huntington
country: United States
facility: Center for Pain Relief Tri-State
state: West Virginia
Study officials:
affiliation: Abbott
name: Robyn Capobianco, PhD
role: STUDY_DIRECTOR
References:
citation: 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.