Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001438842
Ethics application status
Approved
Date submitted
21/09/2021
Date registered
25/10/2021
Date last updated
20/12/2021
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring effect of new brain stimulation technique on brain activity and connectivity in individuals with chronic low back pain
Scientific title
Effect of high definition transcranial infraslow pink noise stimulation on cortical activity and functional connectivity in individuals with chronic low back pain: A pilot randomised placebo-controlled study.
Secondary ID [1] 305362 0
None
Universal Trial Number (UTN)
U1111-1269-6046
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 323698 0
Condition category
Condition code
Musculoskeletal 321233 321233 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High-definition transcranial infraslow pink noise stimulation (HD-tIPNS) will be administered for a single session of 30 minutes using a 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain), by a researcher with health professional background and considerable experience in administering non-invasive neuromodulation techniques. The participants will be positioned comfortably and quietly in a seated/half lying position on a bed, and will wear a neoprene head cap with 32 circular stimulation electrodes placed on it.

For the active treatment group, the stimulation will be delivered at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between.
Intervention code [1] 321771 0
Treatment: Devices
Comparator / control treatment
Sham stimulation: To create an identical skin sensation to the active stimulation, the actisham protocol created by neuroelectrics will be used. The current will be applied for a 60s ramp up (0-2mA) and 60s ramp down (2-0mA) at the beginning and the end of each stimulation session, without any current for the remainder of the stimulation period.
Control group
Placebo

Outcomes
Primary outcome [1] 329021 0
Resting state Electroencephalography: Current density at the pregenual anterior cingulate cortex, dorsal anterior cingulate cortex, and primary somatosensory cortex.
Timepoint [1] 329021 0
Baseline, and Immediately post-intervention
Primary outcome [2] 329022 0
Resting state Electroencephalography: Functional connectivity between the pregenual anterior cingulate cortex, dorsal anterior cingulate cortex, and primary somatosensory cortex.
Timepoint [2] 329022 0
Baseline, and Immediately post-intervention
Primary outcome [3] 329023 0
Any adverse events or side effects (e.g. tingling or burning under stimulation electrodes).

The following variables will be recorded:
•Qualitative description of each symptom
•The intensity of each symptom will be measured using a Likert scale ranging from 0 (none) to 10 (extreme)
•Relation of the symptom to the treatment, measured on a scale ranging from 1 (unrelated) to 5 (strongly related).
•Duration of each symptom and the time taken for resolution of each symptom, expressed in minutes.
•DESS questionnaire
•Any withdrawals due to adverse effects will also be recorded.
Timepoint [3] 329023 0
Immediately post-treatment, and 1 day post-intervention
Secondary outcome [1] 401192 0
Pain Numeric rating scales
(for current pain, average pain, worst pain, unpleasantness, bothersomeness and interference due to pain in past 24 hours)
Timepoint [1] 401192 0
Baseline, and 1 day post-intervention

Eligibility
Key inclusion criteria
• Capable of understanding and signing an informed consent form
• Age between 18 to 75 years on the day of the consent
• Pain in the lower back area (region between the 12th rib and the gluteal fold) that occurs every day for more than or equal to 3 months
• A score of more than 4 on the 11-point numeric pain rating scale (NPRS, 0 is No pain to 10 is Worst pain) in the past 4 weeks
• A disability score of more than or equal to 5 on Roland–Morris Disability Questionnaire
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Inflammatory arthritis
•Undergoing any therapy from a health professional (e.g. physiotherapists or chiropractor)
•Recent soft tissue injuries of the back in the last 3 months
•History of surgery to the back region
•Current intake of any centrally-acting medications or intention of taking new medications on the treatment day.
•Recent steroid injections to the back (in the past 6 months)
•History of neurological diseases
•Unstable medical or psychiatric conditions
•History of epilepsy or seizures
•Presence of any peripheral neuropathy or vascular pathology
•Alcohol or substance abuse
•Dyslipidaemia
•Cognitive impairments (dementia, post-traumatic stress disorders, Alzheimer’s disease)
•History of uncontrolled/untreated hypertension
•Presence of any pacemaker or defibrillator
•Presence of any electronic implants or metal implant in the body (particularly head and neck)
•Recent or current pregnancy

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)
A research administrator, not involved in treatment or assessment procedures, will randomise eligible volunteers using an open-access randomization software program, to one of the two intervention arms (on a 1:1 basis):
• Group 1: High-definition transcranial infraslow pink noise stimulation
• Group 2: Sham stimulation

The randomisation schedule will be concealed in a number sealed and opaque envelopes and provided to the participants at their baseline measurements.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using an open-access randomization software program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
4/11/2021
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
1/02/2022
Actual
Sample size
Target
30
Accrual to date
18
Final
Recruitment outside Australia
Country [1] 24141 0
New Zealand
State/province [1] 24141 0
Otago

Funding & Sponsors
Funding source category [1] 309733 0
Government body
Name [1] 309733 0
Health Research Council
Country [1] 309733 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago,
PO Box 54.
Dunedin 9054.
Country
New Zealand
Secondary sponsor category [1] 310753 0
None
Name [1] 310753 0
Address [1] 310753 0
Country [1] 310753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309490 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 309490 0
Ethics committee country [1] 309490 0
New Zealand
Date submitted for ethics approval [1] 309490 0
26/03/2020
Approval date [1] 309490 0
28/07/2020
Ethics approval number [1] 309490 0

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

Contacts
Principal investigator
Name 114330 0
Dr Divya Adhia
Address 114330 0
Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114330 0
New Zealand
Phone 114330 0
+64 211167594
Fax 114330 0
Email 114330 0
[email protected]
Contact person for public queries
Name 114331 0
Divya Adhia
Address 114331 0
Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114331 0
New Zealand
Phone 114331 0
+64 211167594
Fax 114331 0
Email 114331 0
[email protected]
Contact person for scientific queries
Name 114332 0
Divya Adhia
Address 114332 0
Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114332 0
New Zealand
Phone 114332 0
+64 211167594
Fax 114332 0
Email 114332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHigh-Definition Transcranial Infraslow Pink-Noise Stimulation Can Influence Functional and Effective Cortical Connectivity in Individuals With Chronic Low Back Pain: A Pilot Randomized Placebo-Controlled Study.2023https://dx.doi.org/10.1016/j.neurom.2022.08.450
N.B. These documents automatically identified may not have been verified by the study sponsor.