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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
HOPE Research - TPC
Phoenix, Arizona, United States
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").
Time frame: 3 months
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.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pain Clinic of Monterey Bay
Aptos, California, United States
Coastal Pain Research
Carlsbad, California, United States
Neurovations, Inc.
Napa, California, United States
Newport Beach Headache and Pain
Newport Beach, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Orthopaedic Pain Specialists
Santa Monica, California, United States
IPM Medical Group, Inc.
Walnut Creek, California, United States
Florida Pain Institute
Merritt Island, Florida, United States
Holy Cross Hospital Orthopedic Institute
Oakland Park, Florida, United States
...and 12 more locations