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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06763653




Registration number
NCT06763653
Ethics application status
Date submitted
1/01/2025
Date registered
8/01/2025
Date last updated
8/01/2025

Titles & IDs
Public title
Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain
Scientific title
A Prospective, Multi-Center, Randomized, Controlled Trial to Compare the Safety and Efficacy of Ultra Low Frequency Spinal Cord Stimulation Plus Conservative Medical Management (CMM) to CMM Alone in the Treatment of Chronic Axial Low Back Pain with Prominent Nociceptive Etiology - the FULFILL Study
Secondary ID [1] 0 0
PMH-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nociceptive Pain 0 0
Axial 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 therapy
Other interventions - CMM

Experimental: ULF therapy plus CMM - An implanted SCS device delivering ultra low frequency neuromodulation

Active comparator: CMM alone - Conventional medical management


Treatment: Devices: ULF therapy
ultra low frequency spinal cord stimulation

Other interventions: CMM
conventional medical management
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Back pain VAS responder rate at 3 months
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Composite of back pain relief measured by VAS and functional improvement measured by ODI at 6 months
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Back pain VAS responder rate at 6 months
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Functional improvement measured by ODI at 6 months
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Average change in back pain VAS at 3 months
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Average change in back pain VAS at 6 months
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Average change in disability measured by ODI at 3 months
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
Average change in disability measured by ODI at 6 months
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Average change in health-related quality of life assessed by EQ-5D-5L at 6 months
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Back pain VAS remitter rate at 6 months
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Leg pain VAS responder rate at 3 months
Timepoint [10] 0 0
3 months
Secondary outcome [11] 0 0
Leg pain VAS responder rate at 6 months
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
Average change in opioid dose at 6 months
Timepoint [12] 0 0
6 months

Eligibility
Key inclusion criteria
1. Chronic, intractable nociceptive axial low back pain with or without leg pain (VAS =6 cm for back pain over 7 days) for a minimum of 3 months.
2. Symptoms have failed to respond adequately to conservative therapies, including: physical therapy/exercise, medications, and interventional therapies.
3. Back pain greater than leg pain.
4. ODI score =30 and =80.
5. On stable pain medications or on no pain medications.
6. Considered medically stable and a suitable surgical candidate.
7. Able to operate the device.
8. Willing to sign the Human Research Ethics Committee (HREC)/Institutional Review Board (IRB) approved informed consent form.
9. Willing and deemed capable of complying with the requirements of the study protocol, including attending all scheduled visits.
10. Twenty-two (22) years of age or older.
11. Able to complete questionnaires independently.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study.
2. Suffer from severe cognitive impairment that would impair ability to complete subject questionnaires or operation of the device.
3. Diagnosed with an 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.
4. Presence of spinal stenosis, structural spinal abnormality, or spinal instrumentation observed on MRI or CT that would make lead placement unsafe or untowardly difficult.
5. Previous experience with neuromodulation devices for pain.
6. Opioid usage with average total daily morphine equivalent dose (MED) of >100 mg.
7. Have an untreated addiction to alcohol or other drugs within 6 months of screening visit.
8. Have a cardiac demand pacemaker, implanted defibrillator, or another implanted electronic device.
9. Have a known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject.
10. Have a known need for an MRI or surgery through the end of the study.
11. Candidates of child-bearing potential cannot be pregnant nor plan to become pregnant during the study.
12. Diagnosed with untreated malicious or malignant neoplasms or have a life expectancy of less than 1 year.
13. Be participating in another interventional clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2029
Actual
Sample size
Target
303
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
CerCare Pty Ltd - Wayville
Recruitment hospital [2] 0 0
Monash House Research Centre - Clayton
Recruitment postcode(s) [1] 0 0
- Wayville
Recruitment postcode(s) [2] 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 goal of this clinical trial is to learn if Ultra Low Frequency (ULF) neuromodulation works to treat nociceptive chronic low back pain in adults. It will also evaluate the safety of ULF therapy. The main questions it aims to answer are:

* Does ULF neuromodulation reduce chronic low back pain?
* What, if any, unexpected medical problems do participants experience when treated with ULF neuromodulation?

Researchers will compare ULF therapy to conventional treatments for chronic low back pain. Participants will:

* Be randomly assigned to either the study device or to conventional medical treatments
* Undergo standard surgical procedures to place the study device if assigned to the device arm
* Attend regular clinic visits over 24 months for checkups and data collection
Trial website
https://clinicaltrials.gov/study/NCT06763653
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06763653