Chronic Pain
Conditions
Keywords
Treatment of chronic pain of the trunk and/or limbs.
Brief summary
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.
Interventions
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.
Sponsors
Saluda Medical Pty Ltd
Dustin Reynolds, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is not pregnant and 18 years of age or older at the time of enrollment. * Subject has a minimum NRS score of 6 or higher (where 10 indicates the worst imaginable pain) in primary area of pain at baseline. * Subject is planning to have a temporary trial with the Evoke® System to aid in the management of chronic intractable pain of the trunk and/or limbs. * Subject is willing to program the Evoke® System using EVA™ under the supervision of the study investigator or Qualified Health Professional. * Subject is being trialed with a neurostimulation system for the first time. * Subject is able to read and understand English. * Subject is capable of subjective evaluation; subject must be able to describe and rate his/her pain levels. * Subject is willing and capable of giving informed consent. * Subject is willing and able to comply with study-related requirements, procedures, and visits. * Subject has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator.
Exclusion criteria
\- There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evoke® therapy neural panel metrics generated by EVA™ | At time of EVA programming and through study completion (up to 30 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Locus of Control | Up to 30 days | 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). |
| Numeric Rating Scale | Up to 30 days | 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. |
| PROMIS-29+2 | Up to 30 days | 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. |
Countries
United States
Contacts
Primary ContactMelissa B. Showe
Outcome results
None listed