Dorsal root ganglion stimulation (DRG-S) may be able to treat mechanical pain caused by tissue injury or damage such as trauma or arthritis in addition to pain caused by nerve dysfunction or injury. The purpose of this study is to determine if dorsal root ganglion stimulation (DRG-S) can effectively treat arthritic pain of the knee.
Dorsal root ganglion stimulation (DRG-S) is a novel form of neuromodulation used to treat chronic neuropathic pain of the groin and lower extremities related to complex regional pain syndrome type I or II (causalgia). DRG-S has shown promise in treating traditionally mixed neuropathic and mechanical pain syndromes such as axial low back pain, suggesting DRG-S may be able to treat mechanical pain in addition to neuropathic pain. Additionally, in a rodent model of osteoarthritis of the knee, DRG-S alleviated pain related behavior in rats. This open label feasibility study seeks to evaluate if dorsal root ganglion stimulation with Abbott's Proclaim Dorsal Root Ganglion Neurostimulator System can effectively treat osteoarthritis of the knee. Patients with either osteoarthritis of the non-operated knee or osteoarthritis of the surgically repaired knee will be trialed for one week with dorsal root ganglion stimulation to determine if they positively respond with 50% or greater pain relief. For those patients that have a successful trial, they will be implanted with a permanent stimulation device system and followed for one year post implant to measure knee pain, function and disability, and other related outcomes with sustained DRG-S therapy. Patients will be seen and evaluated prior to DRG-S trial, and for those that receive permanent implants, re-evaluated at 1, 3, 6, 9 and 12 months after implant.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Stimulation at L2, L3, L4 and S1 spinal levels
The Spine and Pain Institute of New York
New York, New York, United States
Treatment success rate at 3 months
Percent of DRG-S implanted patients that successfully respond to stimulation therapy as defined by \>=50% reduction in reported pain score from baseline
Time frame: 3 months post-implant
VAS pain scores
Patient's pain score using standard 10cm pain scale that represents a continuum between "no pain" and "worst pain."
Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
Western Ontario and McMaster Universities Arthritis Index (WOMAC) for knee pain patients
At each study visit, subjects will complete WOMAC survey which assesses pain, stiffness, and function in patients with OA of the knee.
Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
European Quality of Life 5 Dimension (EQ-5D)
At each study visit, subjects will complete EQ-5D survey which assesses health-related quality of life
Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
Short Form 36 Mental Component Summary (SF-36 MCS)
At each study visit, subjects will complete SF-36 MCS survey which assesses mental health
Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
Pain Disability Index (PDI)
At each study visit, subjects will complete PDI survey which assesses pain-related disability
Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
Patient Global Impression of Change (PGIC)
At each study visit, subjects will complete PDI survey which assesses patient's belief about the efficacy of treatment
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Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
Medication Dosage
Patient's dose of narcotic analgesics measured in morphine milligram equivalents (MME) and non-narcotic analgesics and dosages
Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
Timed Up and Go (TUG)
Video recordings of motor task exams will be used to measure TUG, a performance-based measure of functional mobility which measures the time for subject to rise from a chair, walk three meters, turn around, return to the chair, and sit down.
Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
Knee Range of Motion (ROM)
Video recordings of motor task exams will be used to measure ROM of the index knee
Time frame: 1-, 3-, 6-, 9-, and 12 months post-implant
Serum concentrations of molecular biomarkers
Serum concentrations of molecular biomarkers related to knee OA including but not limited to C-telopeptide of crosslinked collagen type I and type II (CTX-I and CTX-II)
Time frame: 3-, 6-, and 12-months post-implant
Kellgren-Lawrence System for Classification of Osteoarthritis
Radiologic classification of subject's knee x-ray to grade progression/severity of osteoarthritis
Time frame: 6- and 12-months post-implant
Treatment success rate at other post-implant timepoints
Percent of DRG-S implanted patients that successfully respond to stimulation therapy as defined by \>=50% reduction in reported pain score from baseline
Time frame: 1-, 6-, 9-, and 12-months post-implant