Assessing the outcomes of patients who undergo spinal cord stimulation compared to patients who undergo spinal fusion surgery for the treatment of chronic low back pain.
- Conditions
- Chronic Low Back PainMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12617001541392
- Lead Sponsor
- Monash Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 58
•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).
•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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the Numerical Pain Rating Scale. [6 months except for patients randomised to the spinal cord stimulation treatment and fail the 7-10 day trial. For the 7-10 day trial spinal cord stimulation failure patients the primary endpoint is 7-10 days.]
- Secondary Outcome Measures
Name Time Method