Clinical trial NCT05837234: Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain
Official title: A Prospective, Open-Label, Multi-Center Trial to Evaluate the Safety and Effectiveness of Ultra Low Frequency Spinal Cord Stimulation in Patients with Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Chronic Low-back Pain
Keywords: Neuromodulation
Spinal Cord Stimulation
Lead sponsor: Presidio Medical, Inc
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 2-year period.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with chronic low back pain with/without leg pain (VAS ≥60mm for back pain for the past week), which has been refractory to conservative therapy for a minimum of 3 months.
2. Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.
3. Is currently considered medically stable as judged by investigator.
4. Able to operate the SCS device (e.g., using remote control) and charge the device appropriately.
5. Determined to be a good surgical candidate by the investigator.
6. Willing to sign the Human Research Ethics Committee (HREC) approved informed consent and deemed capable of complying with the requirements of the study protocol.
7. Willing to stay on stable medications until implantable pulse generator (IPG) activation (i.e., from IPG implant to IPG activation, except for usual postoperative medications required following IPG insertion).
8. Able to comply with study requirements and attend all scheduled visits.
9. Eighteen (18) years of age or older.
10. Literate, able to speak English and able to complete questionnaires independently.

Exclusion Criteria:

1. Diagnosis of active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist in a psychological assessment performed at Baseline.
2. Chronic pain in any area other than back or legs, such that it precludes subject's ability to assess their pain for the primary indication of chronic low back pain as determined by Investigator.
3. Previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).
4. Opioid usage with average total daily morphine equivalent dose (MED) of \>60 mg.
5. A known need for an MRI or surgery within a 2-week period of the screening visit through the end of the study.
6. Female candidates of childbearing potential that are pregnant (confirmed by positive urine/blood pregnancy test) or plan to get pregnant during the duration of the study.
7. Subject is participating in another interventional clinical trial.

Primary outcomes:
measure: Back pain responder rate at 3 months as assessed using a visual analog scale (VAS)
timeFrame: 3 months
Secondary outcomes:
measure: Change in back pain VAS at 3 months
timeFrame: 3 months
measure: Change in back pain VAS at 6 months
timeFrame: 6 months
measure: Change in back pain VAS at 12 months
timeFrame: 12 months
measure: Change in leg pain VAS at 3 months
timeFrame: 3 months
measure: Change in leg pain VAS at 6 months
timeFrame: 6 months
measure: Change in leg pain VAS at 12 months
timeFrame: 12 months
measure: Proportion of participants with a minimal clinically important difference (MCID) as measured by Oswestry Disability Index (ODI) at 3 months
timeFrame: 3 months
measure: Proportion of participants with a MCID as measured by ODI at 6 months
timeFrame: 6 months
measure: Proportion of participants with a MCID as measured by ODI at 12 months
timeFrame: 12 months
measure: Change in EuroQol-5 Dimension (EQ-5D) quality of life index at 3 months
timeFrame: 3 months
measure: Change in EQ-5D quality of life index at 6 months
timeFrame: 6 months
measure: Change in EQ-5D quality of life index at 12 months
timeFrame: 12 months
measure: Proportion of participants with remission of low back pain as assessed by VAS at 6 months
timeFrame: 6 months
measure: Proportion of participants with remission of low back pain as assessed by VAS at 9 months
timeFrame: 9 months
measure: Proportion of participants with remission of low back pain as assessed by VAS at 12 months
timeFrame: 12 months
measure: Change in sleep quality as assessed by Medical Outcomes Study Sleep Scale (MOS-SS) at 3 months
timeFrame: 3 months
measure: Change in sleep quality as assessed by MOS-SS at 6 months
timeFrame: 6 months
measure: Change in sleep quality as assessed by MOS-SS at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Genesis Research Services Pty Ltd
state: New South Wales
city: Wayville
country: Australia
facility: CerCare Pty Ltd
state: South Australia
city: Clayton
country: Australia
facility: Monash House Research Centre
state: Victoria
Study officials:
affiliation: Genesis Research Services
name: Willem Volschenk, MBCHB
role: PRINCIPAL_INVESTIGATOR
affiliation: CerCare
name: Mattew Green, BMBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash House Research Centre
name: Paul Verrills, MBBS
role: PRINCIPAL_INVESTIGATOR
References: