ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000273987

Ethics application status

Approved

Date submitted

7/02/2020

Date registered

2/03/2020

Date last updated

25/06/2021

Date data sharing statement initially provided

2/03/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Neurofeedback for Osteoarthritic Knee Pain

Scientific title

A pilot randomised sham-controlled clinical trial evaluating the feasibility, safety, and acceptability of Infraslow electroencephalography neurofeedback training on experimental and clinical pain outcomes in people with chronic painful knee osteoarthritis.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1241-2310

Trial acronym

Linked study record

Health condition

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

Osteoarthitic Knee Pain

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants allocated to the intervention group will required to attend nine sessions (30 minutes; three sessions/week) of Infraslow Fluctuation-Neurofeedback (ISF-NF) treatment at the school of physiotherapy and two 90-minute sessions for undergoing baseline (S1) and post-intervention assessments (S11).

During each session, participants will be asked to sit on a chair with back supported, and relaxed for 10 minutes, that allows the trainer (University research student) to prepare the participant for NF training. Both ISF-NF and sham ISF-NF will be administered using a 21 channel DC coupled amplifier produced by Brainmaster Inc. The Comby EEG lead cap with sensors (Ag/AgCl) will be fixed to the individual’s scalp, with reference electrodes placed at the mastoids. The impedance of the active electrodes will be monitored through the Mitsar amplifier and will be kept below 5 kilo-ohms. The participants will also be emphasized to minimize the eyeball movement, head and neck movements, swallowing, and clenching of teeth to minimize motion artifact in electroencephalogram (EEG).
Participants will be instructed to close their eyes, relax and listen to the sound being played. A distinct tone will be played when the participant’s brain activity meets ISF (0.0 to 0.1 Hz) magnitude (threshold) at the following cortical areas of the brain: somatosensory cortex (SSC), dorsal anterior cingulate cortex (dACC) and pregenual anterior cingulate cortex (pgACC). The brain regions are chosen based on brain imaging studies on KOA and previous NF studies. Training will be intended to down-train SSC and dACC activity, simultaneously with up-training of pgACC. Efforts will be made to keep the reward threshold in real-time between 60-80%. In other words, for 60-80% of the time, a sound will be played (reward) when the participant's brain activity meets the infraslow magnitude (threshold).

Intervention code [1]

Treatment: Other

Comparator / control treatment

Conditions for the sham ISF-NF group will be the same as ISF-NF group except the participants will receive feedback according to someone else pre-recorded session. To ensure this, we have trained healthy participants with an active NF program for nine sessions and we captured the feedback sound using Audacity software, which is a free and open-source digital audio editor and recording application
Participants in the sham ISF-NF will be prepared as same as ISF-NF group, and they will receive these pre-recorded feedback sound. This process has been incorporated in order to record the real-time EEG of the participants undergoing NF training in the sham group.
The pre-recorded signals will be selected randomly by the chit method form a set of nine files.

Control group

Placebo

Outcomes

Primary outcome [1]

Recruitment rate: The number of participants attending screening assessment will be assessed using participant data from the study records.

Timepoint [1]

Monthly for the first three months of the recruitment period (February, March and April, 2020)

Primary outcome [2]

Randomization rate: a ratio of the number of participants willing to be randomized into the trial from amongst those eligible. This will be assessed using the participant data from the study records.

Timepoint [2]

Monthly for the first three months of the recruitment period (February, March and April, 2020)

Primary outcome [3]

Retention rate: The number of sessions attended by the participant will be assessed from the individual participant data from the study records.

Timepoint [3]

Monthly for the first four months of the intervention period (February, March, April, & May 2020)

Secondary outcome [1]

Pain intensity and interference (composite item)

Timepoint [1]

Brief Pain Inventory tool will be used at baseline (S1) & two days following the last NF session (S11).
Prior to every NF session- Pain intensity and single-item pain interference (same tool).

Secondary outcome [2]

Pain unpleasantness will be measured using a VAS-unpleasantness scale.

Timepoint [2]

Baseline (S1), prior to every NF session, and two days following the last NF session (S11)

Secondary outcome [3]

Pain bothersomeness: Participants will be asked about the bothersomeness (24 Hrs) of their knee pain with a categorical question (not at all, slightly, moderately, very much, extremely)

Timepoint [3]

Baseline (S1), prior to every NF session, and two days following the last NF session (S11)

Secondary outcome [4]

Knee injury and Osteoarthritis Outcome Score (KOOS)

Timepoint [4]