ACTRN12617000239369
Not yet recruiting
未知
The long-term effects of spinal cord stimulation on neural function in chronic low back pain – a pilot study
orthern Sydney Local Health District0 sites30 target enrollmentFebruary 16, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- ower back pain
- Sponsor
- orthern Sydney Local Health District
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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