ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12615000110583

Ethics application status

Approved

Date submitted

27/01/2015

Date registered

6/02/2015

Date last updated

21/04/2021

Date data sharing statement initially provided

21/04/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

The impact of non-invasive brain stimulation on motor cortex excitability and cognition in chronic lower back pain

Scientific title

In individuals with chronic lower back pain, does anodal transcranial direct current stimulation, compared to sham transcranial direct current stimulation, impact on motor cortex excitability and cognition?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Lower Back Pain

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Neurological

Studies of the normal brain and nervous system

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Transcranial Direct Current Stimulation
20 minutes, 2x week, for 4 weeks
Anodal-tDCS sessions will be delivered by a constant current stimulator (Empi) and involve 20 minutes of constant current 2mA stimulation (equivalent to 0.08 Ma/CM2) over their left dorsal lateral prefrontal cortex, the anode electrode will be placed over F3 according to the 10-20 international system for EEG electrode placement.

The intervention will be administered by PhD (psychology) student Emily Corti, under the supervision of Dr Andrea Loftus. Miss Corti has been trained in the administration and safety procedures regarding the use of tDCS. Dr Loftus has an extensive background in the use of tDCS and is the director of the Curtin University Neuroscience Laboratory.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Placebo
Sham tDCS provided to control participants

The tDCS machine can be switched to 'sham' condition, where the tDCS will 'ramp up' for the first 30 seconds of the stimulation time. After the 30 seconds the sham participants will experience no stimulation for 20 minutes. At the end of the 20 minutes the participants will again experience some sensation as the tDCS ramps down. This is to ensure participants are unaware they have been placed in the control group. (The control group can be wait-listed at the end of the study if they wish).
The electrodes are placed in the same position as for the anodal stimulation. The tDCS machine is just switched to 'sham'.

Control group

Placebo

Outcomes

Primary outcome [1]

Motor Cortex Excitability (Short intracortical inhibition, intracortical facilitation, and MEP amplitude) as measured using Transcranial Magnetic Stimulation

Timepoint [1]

Baseline and after 4 weeks of tDCS intervention

Primary outcome [2]

cognitive functioning (executive functioning, working memory/attention, attention, visuospatial and language) measured using 2 tasks for each of the five cognitive domains.
(1) Attention and Working Memory domain: The Letter-Number Sequencing subtest from the Wechsler Adult Intelligence Scale-IV and The Stroop (Colour-Word) Test.
(2) Executive Function domain: The CANTAB Stockings of Cambridge (SOC) subtest and Verbal fluency will be assessed using the Controlled Oral Word Association Task.
(3) Language domain: The Boston Naming Test-Short Form (BNT-Short Form) and the Similarities subtest of the WAIS-IV will be used to assess language.
(4) Memory domain: Hopkins Verbal Learning Test-Revised (HVLT-R) and the Paragraph Recall subtest of the Rivermead Behavioural Memory Test (RMBT) will be used to assess memory.
(5) Visuospatial domain: Judgement of Line Orientation (JLO) and the Hooper Visual Organisation Test (HVOT) will be used to assess visuospatial abilities.

Timepoint [2]

baseline and after 4 weeks of tDCS

Primary outcome [3]

Chronic lower back pain pain as assessed using the Visual Analog scale and the short-form McGill Pain Questionnaire

Timepoint [3]

Baseline, after 4 weeks tDCS intervention

Secondary outcome [1]

Depression as measured by the Depression, Anxiety and Stress Scale

Timepoint [1]

Baseline and after 4 weeks tDCS intervention

Secondary outcome [2]

health related quality of lifes measured by the MOS-36 Health Status Inventory

Timepoint [2]

Baseline and after 4 weeks tDCS intervention

Eligibility

Key inclusion criteria

1) Diagnosis of CLBP by a physician and/or physiotherapist
2) Been diagnosed with CLBP for at least 6 months

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) A Telephone Interview for Cognitive Status-30 score below 18
2) TMS and tDCS exclusion conditions

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

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

9/03/2015

Actual

9/03/2015

Date of last participant enrolment

Anticipated

Actual

1/12/2018

Date of last data collection

Anticipated

Actual

1/12/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

N/A

Address [1]

N/A

Country [1]

Primary sponsor type

Individual

Name

Dr Andrea Loftus

Address

Building 401.210
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Perth
Western Australia 6102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/12/2014

Approval date [1]

29/01/2015

Ethics approval number [1]

Summary

Brief summary

This project will examine motor cortex excitability and cognition in people with chronic low back pain (CLBP). This project will investigate transcranial direct current stimulation (tDCS) for improving motor cortex excitability and cognition in CLBP. Participant’s motor cortex excitability and cognition will be measured before, and after 4-weeks of tDCS. It is predicted CLBP participants will demonstrate abnormal motor cortex excitability and impaired cognitive function, compared with age and gender-matched controls. It is also predicted that tDCS will restore normal motor cortex excitability and improve cognitive functioning in people with CLBP. The findings will provide a better understanding of the relationship between CLBP and the brain and the therapeutic potential of tDCS for CLBP.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrea M Loftus

Address

Building 401.210
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Perth
Western Australia 6102

Country

Australia

Phone

+61 8 9266 2308

Fax

andrea.loftus@curtin.edu.au

Contact person for public queries

Name

Emily Corti

Address

Building 401.210
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Perth
Western Australia 6102

Country

Australia

Phone

+61 431 584 166

Fax

emily.corti@postgrad.curtin.edu.au

Contact person for scientific queries

Name

Andrea M Loftus

Address

Building 401.210
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, Perth
Western Australia 6102

Country

Australia

Phone

+61 8 9266 2308

Fax

andrea.loftus@curtin.edu.au

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

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI
5109	Study results article	Yes	https://doi.org/10.1007/s00221-022-06492-7
5110	Study results article	Yes	https://doi.org/10.3390/brainsci12121654
5111	Study results article	Yes	https://doi.org/10.1016/j.bandc.2021.105737

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically