Safety and performance of Saluda Medical's EvokeTM with feedback control in patients with chronic pain to treat their upper or lower limb pai

Not Applicable

Completed

• Conditions: chronic upper and lower limb pain; Anaesthesiology - Pain management; Neurological - Other neurological disorders; Surgery - Other surgery

• Registration Number: ACTRN12615000713594
• Lead Sponsor: Saluda Medical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-09
• Study Completion: 2019-10-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients selected for this study must meet the following inclusion criteria:
1. Have been diagnosed with chronic, intractable pain (VAS = 6 for the past week), which has been refractory to conservative therapy for a minimum of 3 months.
2. Have been approved to undergo a trial of neural stimulation. Neural stimulation can include cervical or thoracic spinal cord stimulation.
3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
4. Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
5. Be 18 years of age or older at the time of enrolment
6. Be willing and capable of giving written informed consent
7. Be willing and able to comply with study-related requirements, procedures, and visits.
8. Females of childbearing age must have a negative urine pregnancy test at baseline

Exclusion Criteria

Patients selected for this study must not meet the following exclusion criteria:
1. Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
2. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with of intervention and/or ability to evaluate treatment outcomes
3. Are not a surgical candidate due to a diagnosis of an uncontrolled coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
4. Have an implanted pacemaker and/or another SCS system that may interfere with the Saluda system.
5. Have a condition currently requiring or likely to require the use of MRI or diathermy
6. Have a life expectancy of less than 1 year
7. Have an active systemic or local infection
8. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
9. Be pregnant or nursing (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
10. Have within 6 months of enrolment a significant untreated addiction to dependency-producing medications or have been a substance abuser (including alcohol and/or illicit drugs)
11. Be concomitantly participating in another clinical study
12. Be involved in an injury claim under current litigation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Programmability in feedback controlled stimulation mode is defined as the systems ability to automatically adjust stimulation output to maintain a desired ECAP setting determined by the FCE/coordinator or clinician with the subject. [Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, twelve, fifteen, eighteen, twenty one and twenty four months after permanent implant.]