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| Name | Class |
|---|---|
| Saluda Medical Pty Ltd | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCS Evoke System Implant | Subjects with chronic, intractable focal pain of the trunk and/or limbs who undergo Evoke System implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation (SCS) System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of EVA programming and through study completion (up to 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
- There are no exclusion criteria for this study.
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Subjects with chronic, intractable focal pain of the trunk and/or limbs will be screened for participation in this study. Subjects who provide informed consent and meet the eligibility criteria will be enrolled and will undergo a trial procedure. Following the trial phase subjects may receive a permanent implant. Enrollment will continue until 30 subjects receive a permanent implant. We estimate that up to 40 subjects will be enrolled in this registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa B. Showe | Contact | 1-614-775-6607 | melissa.showe@mchs.com |
| Name | Affiliation | Role |
|---|---|---|
| Dustin Reynolds, MD | Mount Carmel Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Carmel Health System | Columbus | Ohio | 43054 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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. | 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. | Up to 30 days |
| D004358 |
| Drug Therapy |