None listed
Conditions
Brief summary
Spinal cord stimulation (SCS) has been employed for the management of chronic pain for over 50 years. Over this time SCS has become a well-established mode of treatment for neuropathic pain. Until recently most success with SCS has been obtained with pain involving the limbs (e.g. CRPS, sciatica, ischaemic limb pain and peripheral neuropathy). Relief of axial back pain has been more difficult to achieve. In response to problems associated with SCS (stimulation variance with body position, MRI lead incompatibility, difficulties covering certain pain sites) a wide range of device options have developed. As a result the number of companies manufacturing implantable spinal cord stimulators continues to increase with each company claiming specific benefits for their device range. The most dramatic recent change has been the introduction of high frequency (HF) SCS (500 Hz to 10,000 Hz). Early work on HF SCS demonstrated potential benefits on axial back pain. The additional feature of “paraesthesia-free” stimulation to avoid the need for paraesthesias required by the more conventional tonic low frequency (LF) SCS (<100Hz) has made this form of stimulation more attractive. Paraesthesias have the potential for discomfort particularly with changes in position (standing to lying). In 2015, a landmark prospective randomised trial was published (Kapural et al) reporting superiority of HF SCS over LF SCS for axial back pain. While the mechanisms of action for conventional SCS are still being investigated, even less is known about HF stimulation. Given the positive results reported by Kapural et al it is likely that the use of HF SCS will dramatically increase. While no definitive evidence of neural damage has been found on clinical examination concern has been raised in animal studies about the potential for long-term neural changes with HF SCS. In addition certain patient subpopulations may be more vulnerable to stimulation induced changes in neural function particularly those with spinal canal stenosis (personal communication). Given Kapural et al has only recently been published consensus regarding the long-term use of HF SCS in axial low back pain is yet to be reached. This pilot study will monitor changes in neural function associated with propriety LF (<100Hz) and HF (10kHz) SCS implantation in people with chronic low back pain over twelve months. The project will inform the development of a full-scale trial. The Global Burden of Disease study now ranks low back pain (LBP) as the number one cause of disability in Australasia. Three million Australians now have long-term disability due to chronic LBP, costing more than $14 billion each year. As a result of a recent successful high profile multi-centre trial HF SCS implantation for chronic LBP is likely to increase. It is crucial therefore to obtain long-term safety data on this treatment to better inform patient selection and future cost benefit analyses.
Interventions
Prior to their enrolment in this study participants will have been assessed as being suitable candidates, as part of their usual medical care, for either a high frequency (10kHz) spinal cord stimulator (SCS) or a low frequency (100Hz) SCS. Assignment to either high frequency SCS or to low frequency SCS occurs as part of a participants usual medical care and does not form part of this trial. Arm 1: Participants with lower back pain who successfully completed a trial implantation and proceeded to have a low frequency SCS fitted. Arm 2: Participants with lower back pain who successfully completed a trial implantation and proceeded to have a high frequency SCS fitted. Participants in Arms 1 and 2 will be enrolled and followed up from approximately two weeks prior to a temporary SCS implantation until a time point 12 months after the implantation of a permanent SCS.
Sponsors
Eligibility
Inclusion criteria
1. Have a primary diagnosis of chronic low back pain (lumbo-sacral) with or without leg pain. 2. Be a candidate for a commercial spinal cord stimulation system. 3. Have responded inadequately to at least 6 months of conservative treatment (pharmacological, physical therapy +/- spinal injections including radiofrequency lesioning). 4. Pain intensity >= 3/10 (NRS11) over previous month. 5. Patients may have had previous spinal surgery. 6. Patients with a known condition that may potentially result in neuropathy will not be excluded (e.g. diabetes, multiple sclerosis). 7. Patients with a significant neuropathy demonstrated on clinical examination (e.g. reflex depression, focal sensory changes or focal muscle weakness, especially lower limbs) will not be excluded. 8. May have undertaken a cognitive behavioural therapy pain program. 9. Be able to consent. 10. Be 18 years or older at the time of enrolment. 11. Be able to comply with study procedures.
Exclusion criteria
1. Have mechanical spinal instability (diagnosed with radiological imaging). 2. Have malignancy with life expectancy <1year. 3. Have a systemic infection. 4. Have other implantable devices. 5. Are participating in another clinical trial. 6. Have unstable major psychiatric comorbidities. 7. Are pregnant/lactating or not using adequate birth control. 8. Have bleeding or coagulopathy issues. 9. Are immunocompromised and at risk of infection. 10. Have uncontrolled insulin-dependent diabetes mellitus despite treatment.