The effects of spinal cord stimulation on nerve function in low back pai

Not Applicable

• Conditions: ower back pain; Lower back pain; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12617000239369
• Lead Sponsor: orthern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-16
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in sensitivity to vibratory stimuli when compared to the pre implantation measure.<br>Vibration sensitivity will be assessed using a standard Rydel-Seiffer tuning fork and also a Medoc VSA-3000 vibrameter.[Baseline and twelve months post permanent SCS implantation.]

Secondary Outcome Measures

Name	Time	Method
Change in sensitivity to vibratory stimuli at 2 weeks, 2 months and six months post implantation, when compared to the baseline score.<br>Vibration sensitivity will be assessed using a standard Rydel-Seiffer tuning fork and also a Medoc VSA-3000 vibrameter.[2 weeks, 2 months and 6 months post permanent SCS implantation.]