Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001143516p
Ethics application status
Not yet submitted
Date submitted
4/09/2024
Date registered
20/09/2024
Date last updated
20/09/2024
Date data sharing statement initially provided
20/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring whether home-based neuromodulation can prevent the transition from acute to chronic low back pain
Scientific title
Exploring whether home-based neuromodulation can prevent the transition from acute to chronic low back pain in adults
Secondary ID [1] 312766 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 334806 0
Condition category
Condition code
Musculoskeletal 331365 331365 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: active transcranial direct current stimulation (tDCS)

Participants will first be given a detailed demonstration of tDCS by a trained investigator. An instructional video regarding correct headpiece positioning for use at home will be provided. Participants will then be assessed their ability to administer and operate the device safely against checklist procedures, and if able to complete all procedures they will be permitted to continue in the trial.

Participants in the intervention group will receive 20 minutes of active home-based tDCS on five consecutive days per week for a total of two weeks. This two-week period of tDCS is consistent with the available literature in chronic pain conditions and laboratory-based studies.

During active tDCS, stimulation with a constant current intensity of 2 mA will be applied over the motor cortex using a Soterix mini-CT Stimulator (Soterix Medical Inc.) with a coded study mode to facilitate randomisation and blinding. The current is delivered via two 5x7cm saline-soaked sponge electrodes. Adherence will be monitored via ElectraRx, a Soterix Medical software platform that can be used by clinicians and patients to facilitate prescribed neuromodulation treatments. Participants’ scheduled treatments will be programmed into ElectraRx by the researcher, and at the end of each session the participant will be provided with a code (via the tDCS device) that can be inputted into the software to confirm the treatment was completed. ElectraRx keeps a record of all scheduled, completed and missed treatments.
Intervention code [1] 329296 0
Treatment: Devices
Intervention code [2] 329297 0
Prevention
Comparator / control treatment
Control: sham tDCS

Participants will first be given a detailed demonstration of tDCS by a trained investigator. An instructional video regarding correct headpiece positioning for use at home will be provided. Participants will then be assessed their ability to administer and operate the device safely against checklist procedures, and if able to complete all procedures they will be permitted to continue in the trial.

Participants in the control group will receive 20 minutes of sham home-based tDCS on five consecutive days per week for a total of two weeks. During sham tDCS, stimulation will be applied over the motor cortex using a Soterix mini-CT Stimulator (Soterix Medical Inc.) with a coded study mode to facilitate randomisation and blinding. The current is delivered via two 5x7cm saline-soaked sponge electrodes. The sham condition will involve identical procedures to the active tDCS, but will only deliver a 30s “ramp up” and “ramp down” stimulation that will range between 0 and 2mA. This replicates the initial tingling sensation of active tDCS, improving the likelihood of blinding success, but is unlikely a sufficient duration to induce any appreciable modulatory effects on the brain. The remainder of the 20-minute intervention period will involve delivery of stimulation averaging no more than 0.002mA (leakage current from the stimulator).
Control group
Placebo

Outcomes
Primary outcome [1] 339127 0
Pain intensity
Timepoint [1] 339127 0
Baseline, daily for two weeks during intervention, immediately post-completion of intervention, weekly for weeks 1-12 post-completion of intervention (12 weeks/3 months is the primary timepoint)
Primary outcome [2] 339128 0
Mechanical sensitivity measured via pressure pain threshold (PPT)
Timepoint [2] 339128 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention (primary timepoint)
Secondary outcome [1] 438649 0
Function
Timepoint [1] 438649 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention
Secondary outcome [2] 438650 0
Corticomotor organisation
Timepoint [2] 438650 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention
Secondary outcome [3] 438651 0
Left/right judgement
Timepoint [3] 438651 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention
Secondary outcome [4] 438652 0
Two point discrimination (TPD)
Timepoint [4] 438652 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention
Secondary outcome [5] 438653 0
Tactile localisation
Timepoint [5] 438653 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention
Secondary outcome [6] 438654 0
Auditory localisation
Timepoint [6] 438654 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention
Secondary outcome [7] 438655 0
Peak alpha frequency (PAF)
Timepoint [7] 438655 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention
Secondary outcome [8] 438656 0
Adherence
Timepoint [8] 438656 0
Each day that tDCS is applied (baseline, day 1,2,3,4,5,8,9,10,11,12 following treatment commencement)
Secondary outcome [9] 438657 0
Tolerability
Timepoint [9] 438657 0
Each day that tDCS is applied (baseline, day 1,2,3,4,5,8,9,10,11,12 following treatment commencement)
Secondary outcome [10] 438658 0
Safety
Timepoint [10] 438658 0
Each day that tDCS is applied (baseline, day 1,2,3,4,5,8,9,10,11,12 following treatment commencement)
Secondary outcome [11] 438659 0
Spatial summation
Timepoint [11] 438659 0
Baseline, 1 week, 1, 2 and 3 months post-completion of intervention

Eligibility
Key inclusion criteria
Eligible participants must be 18 years of age or older and be currently experiencing acute LBP – defined as pain in the region between the 12th thoracic vertebra and the gluteal fold, present for at least 24 hours and no more than 3 months. Participants with referred pain beyond this region may be included provided there is no suspicion of radicular pain from neural tissue involvement. For participants with a history of LBP to be eligible, there must have been a period of at least one month pain-free prior to the current episode. As part of the screening process, numeric pain rating scale (NPRS) values will be recorded for all prospective participants and only those reporting a minimum average weekly pain intensity of 3/10 will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they present with suspected nerve root involvement (e.g. dominant leg pain, positive neural tissue provocation tests and/or any two of altered strength, reflexes, or sensation for the same nerve root, assessed clinically); suspected major spine pathology (e.g. fracture, tumour, cauda equina syndrome); history of lumbar spinal surgery; other acute or chronic pain conditions; neurological disorders or other comorbidities affecting sensorimotor processes; other musculoskeletal impairments beyond the lower back; history of psychiatric disorders requiring pharmacological management (e.g. major depressive disorder, bipolar disorder, schizophrenia) and/or contraindications to home-based tDCS (e.g. physical and/or cognitive inability to operate device safely and reliably, epilepsy, previous adverse reaction to NIBS, metallic/electrical implants at stimulation site). Participants will also be asked to provide a log of any drugs they take currently and within the month preceding the trial, including medication type, frequency and dosage. Participants will be excluded if they take any drugs thought to interfere with tDCS (e.g. benzodiasepines).

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An investigator with no involvement in assessment or intervention delivery will create a randomisation schedule using a random number generator. Allocation will be stratified according to pain duration (< 6 weeks, > 6 weeks).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Efficacy
Statistical methods / analysis
Information collected will be used for analysis purposes only, and will be reported as group data. No individual participant will be identified. Data will be entered into an excel spreadsheet, graphical representations will be constructed, and these data sets will be analysed using the Statistical Package for the Social Sciences software (version 23; IBM Corp, Armonk, NY, USA), with all correlations using the R statistical package (version 2.15.3). Statistical significance will be set at p < 0.05.

Participants will be compared at baseline on all variables using independent T test to assess pre-intervention similarity and the effectiveness of the randomisation process. The effect of home-based tDCS on pain intensity and mechanical sensitivity (PPTs) will be analysed using mixed-model analyses of variance (ANOVAs) with factors “Group” (active versus sham) and “Time” (baseline, 1 week, 1 month, 2 months, and 3 months). Mixed-model ANOVAs will also be used to examine the impact of home-based tDCS on function (ODI), corticomotor function (TMS maps), somatosensory processing (left/right judgement, tactile localisation, two point discrimination, auditory localisation) and EEG measures (PAF) with factors “Group” (active versus sham) and “Time” (baseline, 1 week, 1 month, 2 months, and 3 months). Where appropriate, post-hoc analyses will be performed using Sidak-adjusted multiple comparison tests. Rates of chronic pain development, adverse effects, and adherence (completed sessions) will be compared descriptively. All analyses will be conducted in consultation with an experienced biostatistician.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2024
Actual
Date of last participant enrolment
Anticipated
4/05/2026
Actual
Date of last data collection
Anticipated
10/08/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317198 0
Commercial sector/Industry
Name [1] 317198 0
HCF Research Foundation
Country [1] 317198 0
Australia
Primary sponsor type
Individual
Name
Dr Rocco Cavaleri - Western Sydney University
Address
Country
Australia
Secondary sponsor category [1] 319465 0
University
Name [1] 319465 0
Western Sydney University
Address [1] 319465 0
Country [1] 319465 0
Australia
Other collaborator category [1] 283141 0
Individual
Name [1] 283141 0
Dr Simon Summers
Address [1] 283141 0
Country [1] 283141 0
Australia
Other collaborator category [2] 283142 0
Individual
Name [2] 283142 0
Associate Professor Tasha Stanton
Address [2] 283142 0
Country [2] 283142 0
Australia
Other collaborator category [3] 283143 0
Individual
Name [3] 283143 0
Dr Daniel Thomson
Address [3] 283143 0
Country [3] 283143 0
Australia
Other collaborator category [4] 283144 0
Individual
Name [4] 283144 0
Ariane Suhood
Address [4] 283144 0
Country [4] 283144 0
Australia
Other collaborator category [5] 283175 0
Individual
Name [5] 283175 0
Dr Luke Jenkins
Address [5] 283175 0
Country [5] 283175 0
Australia
Other collaborator category [6] 283176 0
Individual
Name [6] 283176 0
Dr Amitabh Gupta
Address [6] 283176 0
Country [6] 283176 0
Australia
Other collaborator category [7] 283177 0
Individual
Name [7] 283177 0
Dr Ghufran Alhassani
Address [7] 283177 0
Country [7] 283177 0
Australia
Other collaborator category [8] 283180 0
Individual
Name [8] 283180 0
Prof James McAuley
Address [8] 283180 0
Country [8] 283180 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315937 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 315937 0
Ethics committee country [1] 315937 0
Australia
Date submitted for ethics approval [1] 315937 0
14/10/2024
Approval date [1] 315937 0
Ethics approval number [1] 315937 0

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

Contacts
Principal investigator
Name 136274 0
Dr Rocco Cavaleri
Address 136274 0
Western Sydney University, School of Health Sciences, Locked Bag 1797, Penrith, NSW 2751
Country 136274 0
Australia
Phone 136274 0
+61 2 4620 3994
Fax 136274 0
Email 136274 0
[email protected]
Contact person for public queries
Name 136275 0
Rocco Cavaleri
Address 136275 0
Western Sydney University, School of Health Sciences, Locked Bag 1797, Penrith, NSW 2751
Country 136275 0
Australia
Phone 136275 0
+61 2 4620 3994
Fax 136275 0
Email 136275 0
[email protected]
Contact person for scientific queries
Name 136276 0
Rocco Cavaleri
Address 136276 0
Western Sydney University, School of Health Sciences, Locked Bag 1797, Penrith, NSW 2751
Country 136276 0
Australia
Phone 136276 0
+61 2 4620 3994
Fax 136276 0
Email 136276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected throughout the trial, after de-identification. This includes baseline participant characteristics and data relating to all outcome measures listed in Step 4: Outcomes.
When will data be available (start and end dates)?
Immediately following publication, up until 5 years following main results publication
Available to whom?
Available on a case-by-case basis at the discretion of the lead investigator
Available for what types of analyses?
Grant applications and any future studies including systematic reviews
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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
No additional documents have been identified.