The Evoke Spinal Cord Stimulator (SCS) System (Evoke® System) is an FDA-approved device that is used to manage long lasting, severe pain that is not relieved by typical medical treatments. This research registry is being conducted to collect data from patients treated with a SCS device in order to determine how the device impacts their chronic pain condition. Specifically, the study aims to: * Evaluate data collected from the SCS system on how well the system is working. * Evaluate the feasibility of programming the SCS system independently without external assistance. * Evaluate changes in physical function, fatigue, pain interference, mood, sleep, daily activities, pain control, and overall satisfaction with the device.
Study Type
OBSERVATIONAL
Enrollment
40
Spinal cord stimulation system as an aid in the management of chronic intractable pain of the trunk and/or limbs; and will be used within its commercially approved indication.
Mount Carmel Health System
Columbus, Ohio, United States
Evoke® therapy neural panel metrics generated by EVA™
The core neural panel metric generated by the Saluda Medical Evoke® therapy system, specifically via its EVA™ sensing technology, is the Evoked Compound Action Potential (ECAP). ECAPs are objective neurophysiological biomarkers that represent the spinal cord's electrical response to stimulation.
Time frame: At time of EVA programming and through study completion (up to 30 days)
Pain Locus of Control
The PLOC classifies the location in which individuals realize predominantly who or what stops the control of their pain. Factor analysis of the main components of this new scale revealed four dimensions: internal LC, chance LC, other people LC (friends and family), doctor and health professional LC. PLOC will be measured using an adapted version of a general purpose, condition-specific Multidimensional Health Locus of Control (MHLC) scale. The responses will be shortened from 6-level to 4-level: strongly agree, agree, disagree and strongly disagree. Each subscale receives an independent score, ranging from 6 to 24 (internal and chance LC subscales) and from 3 to 12 (health professionals and others LC subscales).
Time frame: Up to 30 days
Numeric Rating Scale
The NRS is a subjective measure of pain. It is a commonly used pain assessment tool where individuals rate their pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain. It's a simple, quick, and widely accepted method for quantifying pain intensity.
Time frame: Up to 30 days
PROMIS-29+2
The PROMIS-29+2 consists of the PROMIS-29 profile (v2.1) and two PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.
Time frame: Up to 30 days
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