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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.
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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.
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Secondary ID [1]
314392
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic musculoskeletal pain
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Neuropathic pain
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Condition category
Condition code
Musculoskeletal
333776
333776
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0
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Other muscular and skeletal disorders
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Neurological
333777
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
331002
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Treatment: Other
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Intervention code [2]
331292
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Recruitment rate
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Assessment method [1]
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The number of participants attending a screening assessment each month. This will be assessed by an audit of recruitment records.
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Timepoint [1]
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Monthly for the first four months of the recruitment period
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Primary outcome [2]
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Safety
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Assessment method [2]
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Discontinuation Emergent Sign and Symptom Scale.
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Timepoint [2]
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Prior to every treatment session and post-intervention (S14)
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Primary outcome [3]
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Enrolment
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Assessment method [3]
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the proportion of participants recruited from the total screened. This will be assessed by an audit of recruitment records.
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Timepoint [3]
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Monthly for the first four months of the recruitment period
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Secondary outcome [1]
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Pain severity
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Assessment method [1]
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Brief pain inventory- short form
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Timepoint [1]
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At the beginning of every session
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Secondary outcome [2]
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Pain unpleasantness
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Assessment method [2]
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11-point numeric scale ( from zero to 10)
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Timepoint [2]
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At the beginning of every session
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Secondary outcome [3]
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Pain bothersomeness
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Assessment method [3]
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Five-point Likert scale
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Timepoint [3]
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At the beginning of every session
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Secondary outcome [4]
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Pain quality
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Assessment method [4]
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PainDETECT questionnaire, Short-form Mcgill Pain Questionnaire 2, Leeds Assessment of Neuropathic Symptoms and signs questionnaire, Dolour Neuropathique 4 interview
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Timepoint [4]
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Baseline assessment (S1) and post-intervention (S14)
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Secondary outcome [5]
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Fatigue
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Assessment method [5]
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10-point numeric rating scale
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Timepoint [5]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [6]
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Depression, anxiety and stress. This will be assessed as a composite outcome.
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Assessment method [6]
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The depression, anxiety and stress scale
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Timepoint [6]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [7]
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Sleep quality and disturbances, this will be assessed as a composite secondary outcome
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Assessment method [7]
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Pittsburgh sleep quality index
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Timepoint [7]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [8]
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Credibility/expectancy of the intervention
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Assessment method [8]
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Credibility/ expectancy questionnaire
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Timepoint [8]
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Post intervention assessment (S14)
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Secondary outcome [9]
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Acceptability of interventions
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Assessment method [9]
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Numeric rating scale (0-7)
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Timepoint [9]
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Post intervention assessment (S14)
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Secondary outcome [10]
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Perceived treatment satisfaction
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Assessment method [10]
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A single item number scale (0-10)
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Timepoint [10]
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Post intervention assessment (S14)
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Secondary outcome [11]
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Patient global impression of change
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Assessment method [11]
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Patient Global Impression of Change score
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Timepoint [11]
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Post intervention assessment (S14)
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Secondary outcome [12]
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Level of engagement with the training
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Assessment method [12]
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10-point numeric rating scale
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Timepoint [12]
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At the end of every session
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Secondary outcome [13]
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Heart rate variability
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Assessment method [13]
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Obtained using a Polar V800 HR monitor and a Polar H10 chest Pro Strap. The electrocardiogram monitor will be placed on the surface below the sternum and secured to ensure a fixed position for the participant. Raw heart rate and R-R interval time series data will be downloaded from the Polar flow software for further processing and analysis
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Timepoint [13]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [14]
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Pressure pain threshold
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Assessment method [14]
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A computerised algometer (AlgoMed, Medoc, Israel) will be used. Pressure will be applied to the test site gradually at a rate of 30kPa/s for each participant by placing a 1cm^2 probe perpendicular to the site until the participant reports that the pressure has become a pain sensation.
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Timepoint [14]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [15]
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Punctate pain intensity
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Assessment method [15]
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This will be assessed using a nylon filament (Semmens monofilament 6.65, 300g). The nylon monofilament will be applied perpendicular to the site on the non-dominant wrist with enough force to bend the filament. Immediately post-trial, participants reported their pain intensity on a 101-point Number rating pain scale (with zero representing no pain at all to 100 representing the most intense pain they have ever experienced).
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Timepoint [15]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [16]
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Mechanical temporal summation
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Assessment method [16]
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This will be assessed using a nylon filament (Semmens monofilament 6.65, 300g).Participants will be instructed to provide a pain rating on a 101-point Number rating pain scale from the punctate pain intensity. Immediately after this, 10 consecutive contacts with an interstimulus interval of one second will be performed and participants will be asked to provide a pain rating on a 101-point Number rating pain scale again.
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Timepoint [16]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [17]
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Vibration detection threshold
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Assessment method [17]
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A tuning fork (64Hz, 8/8 scale) will be used and will be placed on the dorsal aspect of the non-dominant wrist and at the site of the worst pain as indicated by the patient on painDETECT with suprathreshold vibration intensity, and it will be held there until the participant can no longer feel the vibration
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Timepoint [17]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [18]
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Region of interest current density
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Assessment method [18]
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Frequency-specific data will be collected by performing a voxel-by-voxel analysis (containing 6239 voxels) for each of the following frequency bands at dACC and RIns, i.e., infraslow (0.01-0.10 Hz), slow (0.2-1.5 Hz), delta (2–3.5 Hz), theta (4–7.5 Hz), alpha (8–12 Hz, beta (12.5–30 Hz), and gamma (30.5–44 Hz). Comparisons will be made between participants’ pre- and post-treatment measures using the eLORETA statistical contrast maps.
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Timepoint [18]
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Baseline assessment (S1) and post intervention (S14)
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Secondary outcome [19]
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Functional connectivity
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Assessment method [19]
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Lagged linear connectivity will be used as a measure of functional connectivity. The log-transformed lagged linear connectivity will be derived for all possible connections and the seven frequency bands between the Dorsal Anterior Cingulate Cortex and Right Insula.
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Timepoint [19]
447304
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Baseline assessment (S1) and post-intervention (S14)
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Secondary outcome [20]
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Level of motivation
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Assessment method [20]
447305
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11-point single item number scale for each training session and the Current Motivation-Brain computer interface questionnaire at baseline assessment
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Timepoint [20]
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Baseline assessment (S1) and every intervention session (S2-S13)
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Secondary outcome [21]
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Mood
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Assessment method [21]
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11-point numeric rating scale (0 to 10)
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Timepoint [21]
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At the beginning of every intervention session (S2-S13)
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Secondary outcome [22]
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Use of mental strategy
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Assessment method [22]
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Open-ended question
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Timepoint [22]
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Post intervention assessment (S14)
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Secondary outcome [23]
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Mental Fatigue
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Assessment method [23]
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A single item number scale (0-10)
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Timepoint [23]
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Post intervention assessment (S14)
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Secondary outcome [24]
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Pain interference
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Assessment method [24]
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Brief pain inventory- short form
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Timepoint [24]
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At the beginning of every session
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Secondary outcome [25]
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Compliance rate, this is a primary outcome
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Assessment method [25]
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The number of sessions attended by the participant of total. This will be assessed by an audit of recruitment records.
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Timepoint [25]
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Monthly for the first four months of the recruitment period
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Secondary outcome [26]
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Dropout rate, this will be assessed as a primary outcome
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Assessment method [26]
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The number of participants who dropped out over course of the study. This will be assessed by an audit of recruitment records.
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Timepoint [26]
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Monthly for the first four months of the recruitment period
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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.
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Minimum age
35
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
13/06/2025
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Date of last participant enrolment
Anticipated
29/08/2025
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
12
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Accrual to date
2
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Final
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Recruitment outside Australia
Country [1]
27035
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New Zealand
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State/province [1]
27035
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Otago
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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International Association for the Study of Pain Early Career Research Grant
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Address [1]
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Jerin Mathew- University of Otago
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321373
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Country [1]
321373
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
317526
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New Zealand
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Date submitted for ethics approval [1]
317526
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Approval date [1]
317526
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21/11/2023
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Ethics approval number [1]
317526
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EXP 19190
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Summary
Brief summary
One in five New Zealand adults suffers chronic pain, with Maori adults at risk of reporting chronic pain 1.36 times greater than non-Maori adults. Some chronic MSK pain sufferers exhibit neuropathic (NP)-like symptoms such as burning, numbness, and ‘pins and needles’. Emerging evidence suggests that the altered structural and physiological state of brain regions linked to pain experience is responsible for the maintenance of chronic pain states. Brain wave training (neurofeedback) is a biofeedback technique that can be used to modulate the altered brain activity and function of the brain regions associated with chronic pain states. This study, for the first time, investigates the potential of neurofeedback training for managing NP-like symptoms in people suffering from chronic MSK pain conditions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jerin Mathew
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Address
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University of Otago,270 Great King street, Dunedin, 9016
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Country
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New Zealand
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Phone
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+64 0291271413
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jerin Mathew
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Address
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University of Otago,270 Great King street, Dunedin, 9016
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Country
141331
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New Zealand
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Phone
141331
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+64 0291271413
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Fax
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Email
141331
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[email protected]
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Contact person for scientific queries
Name
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Jerin Mathew
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Address
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University of Otago,270 Great King street, Dunedin, 9016
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Country
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New Zealand
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Phone
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+64 0291271413
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Fax
141332
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Email
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[email protected]
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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.
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