Chronic intractable low back and/or radicular leg pain Musculoskeletal Diseases Chronic intractable low back and/or radicular leg pain
Conditions
Interventions
As part of their standard care, participants undergo a trial (temporary evaluation period) of Spinal Cord Stimulation (SCS) at 10 kHz (HF10 Therapy) as per the centre’s usual practice and following th
Sponsors
Nevro Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with chronic intractable back and/or leg pain 2. 18 years of age or older at time of enrolment 3. Currently taking opioids within a dose range of 15-100 mg/day oral morphine or the equivalent (MEDD) 4. Average back or leg pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrolment 5. Meet the requirements for being an HF10 Therapy trial candidate as per the centers’ practice, which includes psychological evaluation 6. Willing and able to complete health questionnaires and pain scales as specified in the protocol
Exclusion criteria
Exclusion criteria: 1. Plans to enrol 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 this study or affect the scientific soundness of this study 2. Medical condition or pain in other area(s), not intended to be treated with SCS, 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 or fibromyalgia) 3. Current addiction to cocaine, opiates, alcohol, or benzodiazepines as determined by the treating physician 4. 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 either the treating physician or a psychologist 5. 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 6. Current diagnosis of a coagulation disorder, bleeding diathesis that would put subject at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease, or uncontrolled diabetes mellitus 7. Diagnosis of scoliosis that precludes lead placement 8. Condition currently requiring or likely to require the use of diathermy 9. Metastatic malignant disease or active local malignant disease 10. Life expectancy of less than 1 year 11. Active systemic or local infection 12. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who report clinical success with HF10 therapy at the 6-month study visit. Clinical success is denoted by any of the following criteria described on the Opioid Use and Pain Outcome Matrix: 1. Decreased opioids (=30%) 2. Decrease in predominant pain (=30%) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be successively evaluated (hierarchical test approach) in the order shown with a 0.05 significance until statistical significance is not achieved: 1. Proportion of subjects who respond to HF10 therapy, assessed at the baseline and after 6 months by a =50% improvement in low back pain or leg pain visual analogue scale (VAS) from the baseline at 6 months 2. Proportion of subjects reporting at least a 30% reduction from baseline in opioid analgesic use as measured by the morphine equivalent daily dose (MEDD) at 6 months 3. Proportion of subjects who respond to HF10 therapy, assessed at the baseline and after 12 months by a =50% improvement in low back pain or leg pain VAS from the baseline at 12 months 4. Proportion of subjects reporting at least a 30% reduction from baseline in opioid analgesic use as measured by the morphine equivalent daily dose (MEDD) at 12 months 5. Proportion of subjects that experience at least a 10-point reduction in the Oswestry Disability Index at 12 months 6. Proportion of patients reporting =0.100 improvement from the baseline in quality of life, assessed using the EQ-5D-5L at 12 months | — |
Countries
Australia
Contacts
Public ContactBrad Gliner
Outcome results
None listed