None listed
Conditions
Brief summary
The main purpose of this study is to determine whether or not patients that are treated by spinal cord stimulation have the same or different treatment outcomes as patients that undergo spinal fusion in a group of patients that have received no treatment in the past for chronic low back pain. The outcomes are measured by pain scores, depression, anxiety and stress scores, patient impression of change, patient functionality, health outcomes assessments and disability scores. The patients' belief in the efficacy of the treatment will also be collected. There is also an aspect of the study that will look at whether spinal cord stimulation in conjunction with spinal fusion leads to better patient outcomes. Eligible subjects will be randomised to either the spinal cord stimulation arm or the fusion arm. Subjects randomised to the spinal cord stimulation arm will undergo an initial spinal cord stimulation trial. If this trial is positive (relieves pain by at least 50%), the subject will then be offered a spinal cord implant. If the trial is not positive, the subject will be withdrawn from the study and offered spinal fusion. If the implant is positive (pain relief of at least 50% is maintained) 6 months post implant, a subject will be followed for a further 12 months. If the implant is negative, the subject will be offered spinal fusion. Outcomes of the fusion will be assessed 6 months after surgery. If the fusion is positive (pain relief of at least 50% is maintained), the subject will be followed for a further 12 months. If the fusion is negative, the subject will be offered reactivation of the spinal cord stimulator. The subject will then be followed for 18 months post reactivation. Subjects randomised to the spinal fusion arm will be assessed 6 months post procedure. If the spinal fusion is positive (pain relief of at least 50% is maintained) , subjects will be followed for a further 12 months. If the spinal fusion is negative, subjects will then be offered a spinal cord stimulation trial. If this trial is positive (at least 50% of pain relief is obtained), subjects will be offered a spinal cord stimulation implant. Subjects will be followed for 18 months post implant (whether positive or negative). If the spinal cord stimulation trial is negative, subjects will be followed for 18 months post the spinal fusion procedure.
Interventions
Subjects will be randomised to either a spinal cord stimulation arm or a spinal fusion arm.
Spinal cord stimulation (SCS) arm: SCS uses a surgically implanted electrical device positioned near the spine that delivers a pulsed current to the spinal cord. The current then suppresses the pain signals being sent to the brain or replaces them with a sensation often described as a tingling, not unpleasant feeling (paraesthesia). A spinal cord stimulation trial is performed first. This involves a surgi
Subjects will be randomised to either a spinal cord stimulation arm or a spinal fusion arm. Spinal cord stimulation (SCS) arm: SCS uses a surgically implanted electrical device positioned near the spine that delivers a pulsed current to the spinal cord. The current then suppresses the pain signals being sent to the brain or replaces them with a sensation often described as a tingling, not unpleasant feeling (paraesthesia). A spinal cord stimulation trial is performed first. This involves a surgical procedure where trial (temporary) leads are placed near the spine and stimulation via an external device is performed for 7-10 days to ascertain whether or not pain relief is obtained. If greater than 50% pain relief is obtained, then a permanent implant will be offered which involves the placement of permanent leads and an implantable pulse generator. If pain relief is not obtained with a spinal cord trial, a subject will be withdrawn from the study and offered fusion. If the spinal cord implant does not maintain pain relief after 6 months, a spinal fusion will be offered. If the spinal fusion does not maintain pain relief after 6 months, reactivation of the SCS will be offered. Spinal fusion arm: Spinal fusion is a surgical technique that stabilises the spinal vertebrae and the disc between the vertebrae. Lumbar fusion surgery has been in use for many decades and is designed to create solid bone between the adjoining vertebrae, eliminating any movement between the bones. The goal of the surgery is to reduce pain and nerve irritation. If spinal fusion does not maintain pain relief 6 months after surgery, a spinal cord stimulation will be offered. If greater than 50% pain relief is obtained from the trial, the subject will be offered a permanent spinal cord stimulation implant. A neurosurgeon will perform spinal fusion or spinal cord stimulation procedures and pain management doctors will perform spinal cord stimulation procedures.
Sponsors
Monash Clinical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Have been diagnosed with chronic low back pain that has persisted for at least 90 days • Pain clinically suspected to be generated from single level lumbar disc disease as assessed by an investigator • Be 18 years of age or older • Have an average pain intensity of at least 6 out of 10 on the Numerical Pain Rating Scale at enrolment. • Willing and able to complete health questionnaires and pain scales as specified in the protocol • Willing and able to sign the study-specific Patient Informed Consent form • Have private health insurance • No previous open back surgery • No previous SCS treatment • No RF treatment in past 12 months • Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study. • Be willing to not increase pain medication, until 6 months after SCS or fusion surgery. This excludes post and peri-operative analgesia administered as per the centres’ standard practice for up to 3 months following surgery. • Imaging, as per standard of care, to ensure suitability for spinal fusion surgery and SCS therapy (MRI +/- CT, +/- X-ray).
Exclusion criteria
• Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in an interventional clinical study that could interfere in participation in the trial or affect the scientific soundness of this study • Have a medical condition or pain in other area(s), not intended to be treated with SCS or fusion, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis and fibromyalgia). • Clinical back instability with surgically unstable spondylolisthesis 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 outcome, as determined by a psychologist or the physician • Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, and/or central deafferentation syndrome. • Have a current diagnosis of a coagulation disorder, bleeding diathesis that would put patient at any increased risk of bleeding during SCS or fusion procedure, progressive peripheral vascular disease or uncontrolled diabetes mellitus. • Having any clinical evidence of mechanical instability or progressive neurologic pathology that warrants surgical intervention. • Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) that would disrupt/obliterate the posterior epidural space. • Have a condition currently requiring or likely to require the use of MRI or diathermy. • Have metastatic malignant disease or active local malignant disease. • Have a life expectancy of less than 1 year. • Have an active systemic or local infection. • Be pregnant (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).
Outcome results
None listed