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Self-regulation (Mindfulness Meditation and Brainwave) Training for People with Knee Osteoarthritis: A Feasibility and Safety Randomized Control Trial.

Mindfulness Meditation and EEG Neurofeedback Training for People with Knee Osteoarthritis: A Feasibility and Safety Randomised Control Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001741875
Acronym
MiNT
Enrollment
23
Registered
2021-12-20
Start date
2023-02-08
Completion date
2023-11-10
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to evaluate the feasibility (recruitment, enrollment, compliance, dropout rates), safety, and participants' perceptions/experiences of mindfulness meditation and neurofeedback training in people with knee osteoarthritis and to determine the variability of the outcome measures. The study outcomes will inform the study design, including sample size for a full randomised clinical control trial.

Interventions

Group-1 will receive Electroencephalography-Neurofeedback (Brainwave) training + usual care. Electroencephalography- Neurofeedback (EEG-NF) training is a form of biofeedback training designed to self-regulate activities of targeted neural areas to improve health outcomes. EEG-NF works under the principles of operant conditioning learning. Real-time feedback (reward) is provided to the participant on reaching a threshold level of the cortical electrical activity at the targeted brain regions li

Group-1 will receive Electroencephalography-Neurofeedback (Brainwave) training + usual care. Electroencephalography- Neurofeedback (EEG-NF) training is a form of biofeedback training designed to self-regulate activities of targeted neural areas to improve health outcomes. EEG-NF works under the principles of operant conditioning learning. Real-time feedback (reward) is provided to the participant on reaching a threshold level of the cortical electrical activity at the targeted brain regions linked to the pain experience, thereby supporting self-regulation of pain and health. In this trial, Electroencephalography (EEG) neurofeedback will be administered four times a week (30 minutes/ session) for a total of 3 consecutive weeks, by trained research personnel. During each session, participants will be asked to close their eyes and sit relaxed on a chair with back support. The Comby EEG lead cap with sensors will be placed on the individual’s scalp. The targeted brain region will include the pregenual anterior cingulate cortex (pgACC). The Brainmaster Inc. system delivers sound feedback (reward) each time the participant’s real-time brain activity at the targeted region meets the desired infraslow threshold (0.0–0.1 Hz) at the targeted cortical area(s). The reward threshold will be adjusted in real-time between 60-80%, i.e., for 60-80% of the time. Group-2 will receive Mindfulness Meditation Training (MMT) + usual care. Mindfulness Meditation Training (MMT): The MMT regimen will consist of twelve 20 minutes sessions which will be administered for three successive weeks with four sessions each week. A trained research assistant will administer the training. During each session, participants will be instructed to focus on the sensation of each breath occurring at the tip of the nose. On progression, participants will be instructed to broaden their focus to the "full flow of the breath", including bodily sensations. We will instruct participants to acknowledge thoughts, feelings, and emotions as they arise without judgment and "simply return their attention back to the breath sensations". Participants in groups 1 and 2 will continue to receive the usual, normal routine care offered by their healthcare providers and carry out self-management strategies. Adherence to training will be recorded through attendance at each training session. Monitoring usual care: Participants (in groups 1 & 2) will record healthcare interventions received and self-management strategies carried out on a weekly basis during the training period. This would be recorded using a self-report questionnaire (digital or paper format).

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: Adults between the ages of 45-85 years, currently living in the wider Dunedin region, meeting 1986 American College of Rheumatology (ACR) clinical criteria for the diagnosis of knee OA, and with knee pain that persisted for longer than three months, will be eligible to participate.

Exclusion criteria

Exclusion criteria: Systemic rheumatic conditions (e.g. rheumatoid arthritis, gout), neurological conditions (e.g. stroke, multiple sclerosis, Parkinson’s disease), untreated heart disease, peripheral arterial diseases in the legs, uncontrolled hypertension (greater than or equal to 150/95), major psychiatric illness, cognitive impairment (Dementia, Alzheimer’s disease), underwent knee joint replacement or other types of surgery to the index knee, intra-articular steroid injections in the past 3 months, Intra-articular hyaluronic acid injections in the past six months, underwent knee joint replacement or knee surgery, scheduled to undergo joint replacement surgery within six months of enrollment, former neurosurgical procedures of the brain, and recent/current pregnancy, former neurosurgical procedures of the brain, and presence of electronic implants or metal implants in the head and neck region

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026