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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06902233




Registration number
NCT06902233
Ethics application status
Date submitted
23/03/2025
Date registered
30/03/2025

Titles & IDs
Public title
Brain Network Stimulation for Chronic Low Back Pain.
Scientific title
High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.
Secondary ID [1] 0 0
24-176
Secondary ID [2] 0 0
2024 FULL 21891
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain (CLBP) 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 - High-definition transcranial infraslow grey noise stimulation
Treatment: Devices - Sham Comparator

Experimental: High definition transcranial infraslow gray noise stimulation (HD-tIGNS) - For the active stimulation group, the HD-tIGNS will be delivered for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between. The gray noise (50%) will be superimposed on the infraslow (0.1Hz) sinusoidal waveform (50%), with the maximum current strength of 2.0 mA per electrode and the maximum total current injected being 4.0mA.

Sham comparator: Sham stimulation - For the sham stimulation group, to create an identical skin sensation to the active stimulation, we will use the Actisham protocol (with FC2 as the itchy electrode) created by the Neuroelectrics. The current will be applied for a 5s ramp up and 5s ramp down at the beginning of each stimulation session, without any current for the remainder of the stimulation period. The sham session will last as long as the HD-tIGNS session to blind the procedure appropriately.


Treatment: Devices: High-definition transcranial infraslow grey noise stimulation
The HD-tIGNS will be used to alter the functional connectivity strength between the three cortical networks \[namely the salience network (SN), the default mode network (DMN) and the somatomotor network (SMN)\] in the infraslow frequency spectrum (0.1 Hz). A total of fifteen circular Ag/AgCl electrodes \[eleven stimulation electrodes (C1, C2, C3, C4, F7, F8, FC3, FT7, FPz, Fz, and O2) and four electrodes with zero current (FC1, FC2, FC4, and FCz)\] will be placed on a neoprene head cap following the International 10-10 EEG system. The optimal montages has been created using the Stimweaver optimization software by the Neuroelectrics company, to specifically decrease the functional connectivity i.e., phase synchronization of the brain regions of the SN with the SMN and the DMN.

Treatment: Devices: Sham Comparator
The Actisham protocol (with FC2 as the itchy electrode) created by the Neuroelectrics will be used for the sham stimulation group. Similar to active group, a total of fifteen circular Ag/AgCl electrodes will be placed on a neoprene head cap following the International 10-10 EEG system to appropriately blind the participant. The electrodes would comprise of four stimulation electrodes (FC1, FC2, FC4, and FCz) and eleven electrodes (C1, C2, C3, C4, F7, F8, FC3, FT7, FPz, Fz, and O2) with zero current.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
The primary endpoint for efficacy assessment of HD-tIGNS will be change in the average pain intensity over the past week from baseline to one-week post completion of treatment.
Secondary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
Change in the average pain intensity over the past week from baseline to one-month, three-months and six-months post completion of treatment.
Secondary outcome [2] 0 0
Pain interference
Timepoint [2] 0 0
Change in the pain interference from baseline to one-week, one-month, three-months and six-months post completion of treatment.
Secondary outcome [3] 0 0
Pain unpleasantness
Timepoint [3] 0 0
Change in the pain unpleasantness from baseline to one-week, one-month, three-months and six-months post completion of treatment.
Secondary outcome [4] 0 0
Pain Bothersomeness
Timepoint [4] 0 0
Change in the pain bothersomeness from baseline to one-week, one-month, three-months and six-months post completion of treatment.
Secondary outcome [5] 0 0
Patient global impression of change
Timepoint [5] 0 0
Recorded at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [6] 0 0
Movement Evoked Pain: Repeated spinal bending
Timepoint [6] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [7] 0 0
Movement Evoked Pain: Back Performance scale
Timepoint [7] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [8] 0 0
Mechanical temporal summation
Timepoint [8] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [9] 0 0
Pressure Pain Threshold
Timepoint [9] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [10] 0 0
Function
Timepoint [10] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [11] 0 0
Health Related Quality of Life
Timepoint [11] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [12] 0 0
Well-Being
Timepoint [12] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [13] 0 0
Depression
Timepoint [13] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [14] 0 0
Catastrophizing
Timepoint [14] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [15] 0 0
Attention to pain
Timepoint [15] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [16] 0 0
Positive and Negative Affect
Timepoint [16] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [17] 0 0
Self-efficacy
Timepoint [17] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [18] 0 0
Intolerance to Uncertainity scale short form
Timepoint [18] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [19] 0 0
Tampa scale of Kinesiophobia
Timepoint [19] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Secondary outcome [20] 0 0
Rescue analgesics / Concomitant treatment
Timepoint [20] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. QAQ will also be collected during intervention period, either at start of sessions (S1, S4, S7, S10) or after completion of the session (S12).
Secondary outcome [21] 0 0
Electroencephalography
Timepoint [21] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. EEG will also be collected during intervention phase either at start of the sessions (S1,S4,S7,S10) or after completion of sessions (S1 and S12).
Secondary outcome [22] 0 0
Emotional Stroop Task
Timepoint [22] 0 0
Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. Stroop testing will be also be done during the intervention phase either at start of sessions (S4, S7, S10) or after completion of session (S12).

Eligibility
Key inclusion criteria
* Age between 18 to 75 years on the day of screening
* Pain in the lower back (region between 12th rib and gluteal fold) with or without accompanying leg pain that occurs for at least half the days in the last six months
* An average pain intensity of =4 on the 11-point NPRS (0=No pain to 10=Pain as bad as you can imagine) in the week prior to enrolment
* A disability score of =5 on Roland-Morris Disability Questionnaire (RMDQ).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known or suspected serious spinal pathology (fracture; lumbar canal stenosis, malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder)
* Suspected or confirmed pregnancy or less than six months post-partum
* Inflammatory disorders
* Auto-immune conditions
* Recent soft tissue injuries of the back in the last 3 months
* Recent steroid injections to the back in the past 3 months
* Recent spinal surgery in the past 12 months or scheduled/waiting for any major surgical procedures during the treatment or follow-up period or underwent rhizotomy or any neurosurgical procedures
* History of neurological conditions, or psychiatric disorders (except depression and anxiety disorders)
* History of cancer, or currently receiving/scheduled for receiving therapy for cancer
* Cognitive impairments (dementia, Alzheimer's disease; indicated by a total score of 24 or below on Mini-Mental State Examination)
* Alcohol or substance abuse
* History of epilepsy or seizures
* Presence of any electronic implants (e.g., pacemaker), metal implant in the body (particularly head and neck), or spinal cord stimulator.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
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
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2028
Actual
Sample size
Target
164
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Divya Adhia, Ph.D
Address 0 0
Department of Surgical Sciences, Dunedin School Of Medicine, University of Otago, Dunedin, New Zealand.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Divya Adhia, Ph.D
Address 0 0
Country 0 0
Phone 0 0
0064211167594
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06902233