ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

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]

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]

Resting state Electroencephalography: Current density at the pregenual anterior cingulate cortex, dorsal anterior cingulate cortex, and primary somatosensory cortex.

Timepoint [1]

Baseline, and Immediately post-intervention

Primary outcome [2]

Resting state Electroencephalography: Functional connectivity between the pregenual anterior cingulate cortex, dorsal anterior cingulate cortex, and primary somatosensory cortex.

Timepoint [2]

Baseline, and Immediately post-intervention

Primary outcome [3]

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]

Immediately post-treatment, and 1 day post-intervention

Secondary outcome [1]

Pain Numeric rating scales
(for current pain, average pain, worst pain, unpleasantness, bothersomeness and interference due to pain in past 24 hours)

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council

Address [1]

Level 3/110 Stanley Street, Grafton, Auckland 1010

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/03/2020

Approval date [1]

28/07/2020

Ethics approval number [1]

Summary

Brief summary

Resting-state cortical activity alterations have been demonstrated in individuals with chronic low back pain. Recent evidence suggests that alterations in the functional connectivity patterns between the pain processing regions [pregenual anterior cingulate cortex (pgACC), dorsal anterior cingulate cortex (dACC), and primary somatosensory (SSC)] are critical for maintaining chronic pain and are associated with its clinical and psychological outcomes. This study will explore the effect of the high-definition transcranial infraslow pink noise stimulation technique on the current density and functional connectivity of the pgACC, dACC, and SSC. 

We hypothesise that this new stimulation technique will be able to alter the brain activity and connectivity at the targeted regions, when compared to sham stimulation technique.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Divya Adhia

Address

Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand

Country

New Zealand

Phone

+64 211167594

Fax

divya.adhia@otago.ac.nz

Contact person for public queries

Name

Divya Adhia

Address

Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand

Country

New Zealand

Phone

+64 211167594

Fax

divya.adhia@otago.ac.nz

Contact person for scientific queries

Name

Divya Adhia

Address

Department of Surgical Sciences,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand

Country

New Zealand

Phone

+64 211167594

Fax

divya.adhia@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	High-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.	2023	https://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.

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Documents added manually

Documents added automatically