Trial Review

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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
ACTRN12625000706471
Ethics application status
Approved
Date submitted
6/06/2025
Date registered
3/07/2025
Date last updated
3/07/2025
Date data sharing statement initially provided
3/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and safety of Brainwave training for joint pain.
Scientific title
Feasibility and safety of neurofeedback intervention for managing neuropathic-like symptoms associated with chronic musculoskeletal pain conditions in participants with musculoskeletal pain; an open-label pilot-feasibility clinical trial.
Secondary ID [1] 314392 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic musculoskeletal pain 337399 0
Neuropathic pain 337847 0
Condition category
Condition code
Musculoskeletal 333776 333776 0 0
Other muscular and skeletal disorders
Neurological 333777 333777 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the start of each session, participants will be seated in a chair with back support and asked to remain relaxed for 10 minutes while the trainer prepares them for the neurofeedback training. The Infraslow- Electroencephalography (EEG) - Neurofeedback training will be administered using a 21-channel DC-coupled amplifier. The Comby EEG lead cap with sensors of an appropriate size will be fitted to the participant’s head, with reference electrodes being placed at the mastoids. The impedance of the active electrodes will be checked to continuously remain below five kilo-ohms. Participants will be advised to minimise eyeball, head and neck movements, swallowing, and clenching of teeth to minimise motion artifacts in the EEG data. Participants will be instructed to relax, keep their eyes closed, and listen to the audio feedback. The BrainMaster Technologies Software (BrainAvatar) will provide real-time auditory feedback each time the participant’s brain activity falls below the target threshold at the ROIs: dorsal anterior cingulate cortex (dACC) and right insula (RIns) in the ISF (0.0-0.1Hz) frequency band. The reward threshold will be continuously monitored by the trainer and adjusted manually (if needed). All participants will be required to attend 12 sessions (30-min each; three sessions per week; four consecutive weeks) of training. Assessment of clinical and EEG outcomes will be carried out at two separate sessions of 90-min duration: baseline assessment and immediately following the final treatment session.

Direct observation method will be followed to ensure treatment adherence.
Intervention code [1] 331002 0
Treatment: Other
Intervention code [2] 331292 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341358 0
Recruitment rate
Timepoint [1] 341358 0
Monthly for the first four months of the recruitment period
Primary outcome [2] 341362 0
Safety
Timepoint [2] 341362 0
Prior to every treatment session and post-intervention (S14)
Primary outcome [3] 341837 0
Enrolment
Timepoint [3] 341837 0
Monthly for the first four months of the recruitment period
Secondary outcome [1] 447274 0
Pain severity
Timepoint [1] 447274 0
At the beginning of every session
Secondary outcome [2] 447275 0
Pain unpleasantness
Timepoint [2] 447275 0
At the beginning of every session
Secondary outcome [3] 447276 0
Pain bothersomeness
Timepoint [3] 447276 0
At the beginning of every session
Secondary outcome [4] 447277 0
Pain quality
Timepoint [4] 447277 0
Baseline assessment (S1) and post-intervention (S14)
Secondary outcome [5] 447278 0
Fatigue
Timepoint [5] 447278 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [6] 447279 0
Depression, anxiety and stress. This will be assessed as a composite outcome.
Timepoint [6] 447279 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [7] 447284 0
Sleep quality and disturbances, this will be assessed as a composite secondary outcome
Timepoint [7] 447284 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [8] 447285 0
Credibility/expectancy of the intervention
Timepoint [8] 447285 0
Post intervention assessment (S14)
Secondary outcome [9] 447286 0
Acceptability of interventions
Timepoint [9] 447286 0
Post intervention assessment (S14)
Secondary outcome [10] 447289 0
Perceived treatment satisfaction
Timepoint [10] 447289 0
Post intervention assessment (S14)
Secondary outcome [11] 447292 0
Patient global impression of change
Timepoint [11] 447292 0
Post intervention assessment (S14)
Secondary outcome [12] 447293 0
Level of engagement with the training
Timepoint [12] 447293 0
At the end of every session
Secondary outcome [13] 447296 0
Heart rate variability
Timepoint [13] 447296 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [14] 447299 0
Pressure pain threshold
Timepoint [14] 447299 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [15] 447300 0
Punctate pain intensity
Timepoint [15] 447300 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [16] 447301 0
Mechanical temporal summation
Timepoint [16] 447301 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [17] 447302 0
Vibration detection threshold
Timepoint [17] 447302 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [18] 447303 0
Region of interest current density
Timepoint [18] 447303 0
Baseline assessment (S1) and post intervention (S14)
Secondary outcome [19] 447304 0
Functional connectivity
Timepoint [19] 447304 0
Baseline assessment (S1) and post-intervention (S14)
Secondary outcome [20] 447305 0
Level of motivation
Timepoint [20] 447305 0
Baseline assessment (S1) and every intervention session (S2-S13)
Secondary outcome [21] 447745 0
Mood
Timepoint [21] 447745 0
At the beginning of every intervention session (S2-S13)
Secondary outcome [22] 448515 0
Use of mental strategy
Timepoint [22] 448515 0
Post intervention assessment (S14)
Secondary outcome [23] 448528 0
Mental Fatigue
Timepoint [23] 448528 0
Post intervention assessment (S14)
Secondary outcome [24] 448792 0
Pain interference
Timepoint [24] 448792 0
At the beginning of every session
Secondary outcome [25] 448795 0
Compliance rate, this is a primary outcome
Timepoint [25] 448795 0
Monthly for the first four months of the recruitment period
Secondary outcome [26] 448796 0
Dropout rate, this will be assessed as a primary outcome
Timepoint [26] 448796 0
Monthly for the first four months of the recruitment period

Eligibility
Key inclusion criteria
Participants between 35-75 years of age with Musculoskeletal pain [(measured by a greater than or equal to four on the 11-point numeric pain rating scale (NPRS)] on average for the past three months, for a minimum duration of three months and have a score of at least 19 points on the PainDETECT questionnaire will be eligible to participate in the study.
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Systemic rheumatic conditions, neurological conditions, major psychiatric illness, cervical and lumbar radiculopathy, peripheral entrapment neuropathies, cognitive impairment, has undergone any surgery/ intra-articular steroid injections in the three months prior to the study, has undergone any intra-articular hyaluronic acid injections in the six months prior to the study, has been scheduled to undergo any surgery within six months of enrolment to the study, former neurological procedures of the brain, pregnant or up to six months post-partum, cardiovascular disease, peripheral arterial diseases of limbs, uncontrolled hypertension (greater than or equal to 150/95), uncontrolled diabetes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Participant demographics, feasibility, and safety data over the course of the study will be summarised descriptively. A within-group pre-post statistical comparison will be conducted for all the secondary outcome measures. A correlation analysis will be performed to explore the relationship between EEG measures, self-report, heart rate variability and quantitative sensory testing measures. Since this is a pilot-feasibility study, the sample size was not determined for power.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/06/2025
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
12
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 27035 0
New Zealand
State/province [1] 27035 0
Otago

Funding & Sponsors
Funding source category [1] 318911 0
Charities/Societies/Foundations
Name [1] 318911 0
International Association for the Study of Pain Early Career Research Grant
Country [1] 318911 0
New Zealand
Primary sponsor type
Individual
Name
Jerin Mathew- University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321373 0
None
Name [1] 321373 0
Address [1] 321373 0
Country [1] 321373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317526 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317526 0
Ethics committee country [1] 317526 0
New Zealand
Date submitted for ethics approval [1] 317526 0
Approval date [1] 317526 0
21/11/2023
Ethics approval number [1] 317526 0
EXP 19190

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

Contacts
Principal investigator
Name 141330 0
Dr Jerin Mathew
Address 141330 0
University of Otago,270 Great King street, Dunedin, 9016
Country 141330 0
New Zealand
Phone 141330 0
+64 0291271413
Fax 141330 0
Email 141330 0
[email protected]
Contact person for public queries
Name 141331 0
Jerin Mathew
Address 141331 0
University of Otago,270 Great King street, Dunedin, 9016
Country 141331 0
New Zealand
Phone 141331 0
+64 0291271413
Fax 141331 0
Email 141331 0
[email protected]
Contact person for scientific queries
Name 141332 0
Jerin Mathew
Address 141332 0
University of Otago,270 Great King street, Dunedin, 9016
Country 141332 0
New Zealand
Phone 141332 0
+64 0291271413
Fax 141332 0
Email 141332 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.