This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.
Multi-center, prospective, open-label, randomized controlled trial (RCT) comparing PNS plus CMM with CMM alone. Subjects will be randomized to receive: Arm 1: Nalu Neurostimulation System for PNS plus CMM Arm 2: CMM alone Consented subjects will receive a baseline evaluation and then be randomized 2:1 into one of two arms: 1) PNS+CMM arm or 2) CMM arm. Subjects assigned to Arm 1 will undergo a trial implant period using best clinical practices. Those subjects who pass the trial implant will receive the permanent implant. At the 3-month end point, subjects in Arm 2 will be given the option to crossover into Arm 1 beginning with a trial implant. All Arm 1 patients receiving a permanent implant will be followed for a total of 36 months after permanent implantation.Arm 2 patients who do not crossover will be followed for a total of 36 months from randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
185
The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator
Conventional Medical Management is the best standard of care treatment for the patient
The Pain Institute of Southern Arizona
Tucson, Arizona, United States
Comprehensive Spine & Pain Physicians
Burbank, California, United States
Effectiveness: Responder Rates between the 2 groups
Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the Numeric Rating Scale (0-10; 0=no pain, 10=worst pain imaginable)
Time frame: 3-months
Safety: Rate of serious and non-serious device effects
Rate of serious and non-serious adverse device events between groups
Time frame: 3-months
Responder Rates
Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the BPI-Q5 (NRS,0-10 where, 0= no pain; 10=worst pain imaginable).
Time frame: 6-months,12 months, 24 months and 36-months
Functional Outcomes: Change in Oswestry Disability Index (ODI) score from baseline to protocol defined timepoints
Change in patient reported ODI from baseline with comparisons between groups. The ODI is scored from 0-100% disability. A lower score, compared to baseline, indicates improvement in ODI.
Time frame: 3 months, 6-months,12 months, 24 months and 36-months
Functional Outcomes: Change in Beck's Depression Inventory (BDI) score from baseline
Change in patient reported depression from baseline with comparison between groups. The BDI is scored from 0-63. A lower score at follow-up, compared to baseline, indicates an improvement in depression symptoms and mood.
Time frame: 3 months, 6-months,12 months, 24 months and 36-months
Functional Outcomes: Patient Global Impression of Change (PGIC)
PGIC is reported by the patient post-implant, on a 7-point likert scale to indicate overall changes in mood, activity, emotional well-being and quality of life. Proportion of patients showing improvement, worsening or no change, will be collected and reported at protocol specified time points.
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Pain Management and Injury Relief
Thousand Oaks, California, United States
DBPS Research LLC
Denver, Colorado, United States
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, United States
Coastal Spine & Pain Center
Jacksonville, Florida, United States
University of Kansas Health System, Bell Hospital Marc A. Asher Comprehensive Spine Center
Kansas City, Kansas, United States
Insight Research Institute
Flint, Michigan, United States
NeuroInterventional Pain Management
Monroe, Michigan, United States
Michigan Neurology & Spine Center
Port Huron, Michigan, United States
...and 7 more locations
Time frame: 3 months, 6-months,12 months, 24 months and 36-months
Safety Assessment
Rate of serious and non-serious device effects
Time frame: 6-months,12 months, 24 months and 36-months