The Presidio Medical Ultra Low Frequency (ULF™) Spinal Cord Stimulation (SCS) System is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.
This is a prospective, open-label, multi-center clinical trial in which participants with chronic low back pain (CLBP) with/without leg pain will be invited to enroll and undergo treatment with the ULF SCS system. The purpose of this study is to evaluate the safety and effectiveness of ULF SCS over a 3-year period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Ultra low frequency spinal cord stimulation
Genesis Research Services Pty Ltd
Newcastle, New South Wales, Australia
CerCare Pty Ltd
Wayville, South Australia, Australia
Monash House Research Centre
Clayton, Victoria, Australia
Back pain responder rate at 3 months as assessed using a visual analog scale (VAS)
A responder is defined as a participant that achieved at least 50% reduction in back pain at the follow-up compared to baseline. Responder rate is defined as the percentage of participants that were responders.
Time frame: 3 months
Change in back pain VAS at 3 months
The mean percentage change in VAS back pain intensity from baseline.
Time frame: 3 months
Change in back pain VAS at 6 months
The mean percentage change in VAS back pain intensity from baseline.
Time frame: 6 months
Change in back pain VAS at 12 months
The mean percentage change in VAS back pain intensity from baseline.
Time frame: 12 months
Change in leg pain VAS at 3 months
The mean percentage change in VAS leg pain intensity from baseline. Calculated only for participants who scored at least 40 out of 100mm for leg pain at baseline.
Time frame: 3 months
Change in leg pain VAS at 6 months
The mean percentage change in VAS leg pain intensity from baseline. Calculated only for participants who scored at least 40 out of 100mm for leg pain at baseline.
Time frame: 6 months
Change in leg pain VAS at 12 months
The mean percentage change in VAS leg pain intensity from baseline. Calculated only for participants who scored at least 40 out of 100mm for leg pain at baseline.
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Time frame: 12 months
Proportion of participants with a minimal clinically important difference (MCID) as measured by Oswestry Disability Index (ODI) at 3 months
The MCID is defined as at least a 10-point improvement on ODI.
Time frame: 3 months
Proportion of participants with a MCID as measured by ODI at 6 months
The MCID is defined as at least a 10-point improvement on ODI.
Time frame: 6 months
Proportion of participants with a MCID as measured by ODI at 12 months
The MCID is defined as at least a 10-point improvement on ODI.
Time frame: 12 months
Change in EuroQol-5 Dimension (EQ-5D) quality of life index at 3 months
The mean change in EQ-5D index from baseline.
Time frame: 3 months
Change in EQ-5D quality of life index at 6 months
The mean change in EQ-5D index from baseline.
Time frame: 6 months
Change in EQ-5D quality of life index at 12 months
The mean change in EQ-5D index from baseline.
Time frame: 12 months
Proportion of participants with remission of low back pain as assessed by VAS at 6 months
Remission is defined as VAS score of 30mm or less for 6 consecutive months.
Time frame: 6 months
Proportion of participants with remission of low back pain as assessed by VAS at 9 months
Remission is defined as VAS score of 30mm or less for 6 consecutive months.
Time frame: 9 months
Proportion of participants with remission of low back pain as assessed by VAS at 12 months
Remission is defined as VAS score of 30mm or less for 6 consecutive months.
Time frame: 12 months
Change in sleep quality as assessed by Medical Outcomes Study Sleep Scale (MOS-SS) at 3 months
The mean change in MOS-SS index from baseline.
Time frame: 3 months
Change in sleep quality as assessed by MOS-SS at 6 months
The mean change in MOS-SS index from baseline.
Time frame: 6 months
Change in sleep quality as assessed by MOS-SS at 12 months
The mean change in MOS-SS index from baseline.
Time frame: 12 months