Back Pain, Chronic Pain, Pain
Conditions
Keywords
Chronic Pain, Back Pain, Leg Pain, Pain, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, SCS, Closed Loop
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
Interventions
DEVICEEvoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
Sponsors
Saluda Medical Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject is male or female between the ages of 18 and 80 years. * Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months. * Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator. * Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.
Exclusion criteria
* Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator. * Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes. * Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS). * Have prior experience with SCS. * Have an active systemic infection or local infection in the area of the surgical site. * Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal). * Be concomitantly participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Endpoint Success | 3 months | The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Leg Pain VAS Score | 3 months | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. |
| Percent Change From Baseline in Back Pain VAS Score | 3 months | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. |
| Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | 3 months | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. |
| Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | 3 months | VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain |
| Number of Participants With Composite Endpoint Success | 12 months | The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Evoke SCS With Feedback closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). | 67 |
| Evoke SCS With Conventional open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System: Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs). | 67 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event Unrelated to Device or Stimulation | 2 | 1 |
| Overall Study | Missed Visit | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Evoke SCS With Feedback | Total | Evoke SCS With Conventional |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 9.7 | 55.2 years STANDARD_DEVIATION 10.6 | 55.9 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 125 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 63 Participants | 122 Participants | 59 Participants |
| Region of Enrollment United States | 67 participants | 134 participants | 67 participants |
| Sex: Female, Male Female | 33 Participants | 65 Participants | 32 Participants |
| Sex: Female, Male Male | 34 Participants | 69 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 |
| other Total, other adverse events | 14 / 67 | 15 / 67 |
| serious Total, serious adverse events | 7 / 67 | 4 / 67 |
Outcome results
Primary
Number of Participants With Composite Endpoint Success
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 3 months
Population: Intention-to-Treat (ITT), which included randomized patients with either known endpoint status or classified as a presumed non-responder (i.e., \<50% reduction in overall pain at trial or withdrew due to a device- or stimulation-related adverse event), and therefore imputed as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evoke SCS With Feedback | Number of Participants With Composite Endpoint Success | 51 Participants |
| Evoke SCS With Conventional | Number of Participants With Composite Endpoint Success | 38 Participants |
p-value: <0.001normal approximation to the binomial
Secondary
Number of Participants With Composite Endpoint Success
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 12 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evoke SCS With Feedback | Number of Participants With Composite Endpoint Success | 49 Participants |
| Evoke SCS With Conventional | Number of Participants With Composite Endpoint Success | 36 Participants |
p-value: <0.001normal approximation to the binomial
Secondary
Percent Change From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 3 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evoke SCS With Feedback | Percent Change From Baseline in Back Pain VAS Score | 72.1 percentage change in VAS back pain | Standard Deviation 29.4 |
| Evoke SCS With Conventional | Percent Change From Baseline in Back Pain VAS Score | 57.5 percentage change in VAS back pain | Standard Deviation 36.4 |
p-value: <0.00195% CI: [2.9, 26.3]t-test, 2 sided
Secondary
Percent Change From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 12 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evoke SCS With Feedback | Percent Change From Baseline in Back Pain VAS Score | 69.4 percentage change in VAS back pain | Standard Deviation 30.6 |
| Evoke SCS With Conventional | Percent Change From Baseline in Back Pain VAS Score | 54.0 percentage change in VAS back pain | Standard Deviation 39.5 |
p-value: <0.00195% CI: [2.5, 28.3]t-test, 2 sided
Secondary
Percent Change From Baseline in Leg Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 12 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evoke SCS With Feedback | Percent Change From Baseline in Leg Pain VAS Score | 72.9 percentage change in VAS leg pain | Standard Deviation 31 |
| Evoke SCS With Conventional | Percent Change From Baseline in Leg Pain VAS Score | 62.1 percentage change in VAS leg pain | Standard Deviation 37.5 |
p-value: <0.00195% CI: [-1.8, 23.3]t-test, 2 sided
Secondary
Percent Change From Baseline in Leg Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 3 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evoke SCS With Feedback | Percent Change From Baseline in Leg Pain VAS Score | 76.8 percentage change in VAS leg pain | Standard Deviation 28.3 |
| Evoke SCS With Conventional | Percent Change From Baseline in Leg Pain VAS Score | 67.8 percentage change in VAS leg pain | Standard Deviation 35.5 |
p-value: <0.00195% CI: [-2.4, 20.4]t-test, 2 sided
Secondary
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 3 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evoke SCS With Feedback | Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | 50 Participants |
| Evoke SCS With Conventional | Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | 36 Participants |
p-value: <0.001normal approximation to the binomial
Secondary
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 12 months
Population: Intention-to-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evoke SCS With Feedback | Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | 47 Participants |
| Evoke SCS With Conventional | Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score | 34 Participants |
p-value: <0.001normal approximation to the binomial
Secondary
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Time frame: 3 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evoke SCS With Feedback | Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | 36 Participants |
| Evoke SCS With Conventional | Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | 27 Participants |
p-value: 0.002normal approximation to the binomial
Secondary
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Time frame: 12 months
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evoke SCS With Feedback | Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | 33 Participants |
| Evoke SCS With Conventional | Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score | 22 Participants |
p-value: <0.001normal approximation to the binomial