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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05837234




Registration number
NCT05837234
Ethics application status
Date submitted
19/04/2023
Date registered
1/05/2023
Date last updated
13/12/2023

Titles & IDs
Public title
Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain
Scientific 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
Secondary ID [1] 0 0
PMH-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Chronic Low-back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ULF SCS

Experimental: ULF SCS - Participants with chronic low back pain that is refractory to conservative care will undergo temporary trial stimulation with the ULF SCS system. Those receiving at least 50% pain relief of their chronic back pain will be eligible for a permanent device implant and followed for 12 months.


Treatment: Devices: ULF SCS
Ultra low frequency spinal cord stimulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Back pain responder rate at 3 months as assessed using a visual analog scale (VAS)
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Change in back pain VAS at 3 months
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Change in back pain VAS at 6 months
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Change in back pain VAS at 12 months
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Change in leg pain VAS at 3 months
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Change in leg pain VAS at 6 months
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Change in leg pain VAS at 12 months
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Proportion of participants with a minimal clinically important difference (MCID) as measured by Oswestry Disability Index (ODI) at 3 months
Timepoint [7] 0 0
3 months
Secondary outcome [8] 0 0
Proportion of participants with a MCID as measured by ODI at 6 months
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Proportion of participants with a MCID as measured by ODI at 12 months
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Change in EuroQol-5 Dimension (EQ-5D) quality of life index at 3 months
Timepoint [10] 0 0
3 months
Secondary outcome [11] 0 0
Change in EQ-5D quality of life index at 6 months
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
Change in EQ-5D quality of life index at 12 months
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Proportion of participants with remission of low back pain as assessed by VAS at 6 months
Timepoint [13] 0 0
6 months
Secondary outcome [14] 0 0
Proportion of participants with remission of low back pain as assessed by VAS at 9 months
Timepoint [14] 0 0
9 months
Secondary outcome [15] 0 0
Proportion of participants with remission of low back pain as assessed by VAS at 12 months
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
Change in sleep quality as assessed by Medical Outcomes Study Sleep Scale (MOS-SS) at 3 months
Timepoint [16] 0 0
3 months
Secondary outcome [17] 0 0
Change in sleep quality as assessed by MOS-SS at 6 months
Timepoint [17] 0 0
6 months
Secondary outcome [18] 0 0
Change in sleep quality as assessed by MOS-SS at 12 months
Timepoint [18] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Genesis Research Services Pty Ltd - Newcastle
Recruitment hospital [2] 0 0
CerCare Pty Ltd - Wayville
Recruitment hospital [3] 0 0
Metro Pain Research Institute - Clayton
Recruitment postcode(s) [1] 0 0
- Newcastle
Recruitment postcode(s) [2] 0 0
- Wayville
Recruitment postcode(s) [3] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Presidio Medical, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05837234
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Willem Volschenk, MBCHB
Address 0 0
Genesis Research Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Valerie Cimmarusti
Address 0 0
Country 0 0
Phone 0 0
+1 (626) 353-8667
Fax 0 0
Email 0 0
vcimmarusti@presidiomedical.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05837234