None listed
Conditions
Brief summary
This study seeks to evaluate the safety and the effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of lower back pain with or without leg pain. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength than other traditional spinal cord stimulators and it may help to alleviate pain.
Interventions
The purpose of this study is to compare the safety and efficacy of Ultra-Low Frequency Spinal Cord Stimulation (ULF-SCS Presidio System) to Traditional Spinal Cord Stimulation (SCS) over a 15 day period in subjects with chronic, intractable back pain with/without leg pain.
The Presidio Medical ULF-SCS system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) and low frequency (1-500Hz) electrical currents to the epidural space to block the conduction of ner
The purpose of this study is to compare the safety and efficacy of Ultra-Low Frequency Spinal Cord Stimulation (ULF-SCS Presidio System) to Traditional Spinal Cord Stimulation (SCS) over a 15 day period in subjects with chronic, intractable back pain with/without leg pain. The Presidio Medical ULF-SCS system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) and low frequency (1-500Hz) electrical currents to the epidural space to block the conduction of nerve pain. The participants will have epidural leads implanted for 15 days in an operating room setting. It will be performed by a pain management specialist surgeon in a day surgery setting under general or sedation anaesthesia with a procedure lasting approximately 1 hr. The trial system consists of epidural leads (implanted in the T8-T10 region), lead adapters, an external pulse generator (EPG), surface electrodes and a programming application. The participant will wear the EPG on a hip belt and will have control to continue, pause or stop stimulation. The participant will return to the clinic at days 1, 3 and 7 to adjust their stimulation. The device is anticipated to provide near continuous stimulation throughout the trial though it is able to be paused or stopped by the participant. The entire system will be removed at Day 15. The usage data from the device will be downloaded at every clinic visit to assess for total run time and device performance. The study utilizes a multi-centre, prospective, randomized, controlled, non-inferiority two-arm design. Randomization to a control Group allows for the ability to discriminate between improvement in outcomes due to the investigational treatment vs standard therapy. The nature of the two types of stimulation precludes blinding of subjects and study staff. Traditional SCS generates paresthesia whereas ULF-SCS does not.
Sponsors
Presidio Medical AU, Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eighteen (18) years of age or older 2. Literate, able to speak English and able to complete questionnaires independently 3. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 4. Have been diagnosed with chronic low back pain with/without associated leg pain (VAS greater than 50mm for the past week), which has been refractory to conservative therapy for a minimum of 3 months 5. Are currently receiving optimal medical management and considered medically stable as judged by investigator 6. Ability to independently change AA batteries and operate EPG. 7. Able to comply with study requirements and attend all scheduled visits
Exclusion criteria
1. If female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least two years post-menopausal 2. Severe cognitive impairment as determined by Investigator 3. A psychological assessment will be performed at Baseline to exclude 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 outcome. This will be performed by a clinical psychologist/ psychiatrist 4. Pre-existing motor, balance, proprioception, or sensory deficits as determined by investigator 5. Spinal stenosis or other structural spinal abnormality observed on MRI that would make lead placement unsafe or untowardly difficult as determined by investigator 6. Average total daily morphine equivalent dose (MED) of greater than 100 mg 7. Currently taking anticoagulants including Warfarin, Heparin, Low Molecular Weight Heparin, Factor Xa inhibitors, GPIIb/IIIa inhibitors, thienopyridine inhibitors, direct thrombin inhibitors, or any other anticoagulant that is a contraindication to epidural lead placement within 1 week of the Screening Visit 8. Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by clinical history and, if clinically indicated, by coagulation screening) 9. Cardiac demand pacemaker, implanted defibrillator or another implanted electronic device 10. A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) 11. Known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject 12. Previous use of spinal cord stimulation or comparable therapy 13. For subjects with diagnosed diabetes, a Hemoglobin A1C (HgB A1C) level that is greater than (greater than) 8.55% 14. Body Mass Index (BMI) score that is greater than 40 15. Diagnosis of Fibromyalgia 16. VAS of greater than 30mm in any area other than back or legs 17. A known need for an MRI or surgery within a 2-week period of the screening visit. 18. Any experimental drug or device used within 30 days prior to the Screening Visit or during the course of the clinical trial 19. No access to a computer or mobile device 20. Subjects who are involved in ongoing or closed litigation related to their pain condition
Outcome results
None listed