None listed
Conditions
Brief summary
Patellofemoral pain (PFP) is a broad term used to describe non-specific pain that arises at the front of the knee, caused by overloading of the knee joint. Although many people live with PFP, the management of this condition is challenging, and we do not fully understand what causes long-lasting pain. A significant number of people continue to experience PFP after a year of standard treatment, and this can persist for a long time, often developing into chronic pain. Recent research in PFP and other chronic musculoskeletal pain conditions has shown increased nervous system sensitivity and even altered brain function. Emerging research suggests that changes in brain regions involved in pain are related to chronic pain states. Neurofeedback (NF), or brain-wave training, is an emerging technique that can be used to regulate brain activity and function in brain regions associated with chronic pain states. NF helps individuals self-regulate their brain activity through real-time auditory feedback and has been shown to be effective in managing other chronic pain conditions. This study aims to: 1. Investigate the feasibility, safety and acceptability of NF as a treatment for PFP. 2. Explore the immediate and short-term effects of NF training on pain and function in individuals with PFP. This treatment may have the potential to help individuals with PFP manage their pain when existing treatments aren’t very effective. If NF training is safe, acceptable, and feasible, then we hope to conduct a fully powered clinical trial to further evaluate its effectiveness and establish it as a real treatment option for people with PFP.
Interventions
Eligible participants will attend 12 electroencephalography neurofeedback (EEG-NF) sessions (three sessions per week for 30 minutes each) at the Department of Anatomy Research Clinic facility, University of Otago. During each session, participants will be asked to sit in a chair with their back supported and remain relaxed for 10 minutes, allowing the trainer to prepare them for the EEG-NF training. The training will be administered using a 21-channel DC-coupled amplifier produced by BrainMaster
Eligible participants will attend 12 electroencephalography neurofeedback (EEG-NF) sessions (three sessions per week for 30 minutes each) at the Department of Anatomy Research Clinic facility, University of Otago. During each session, participants will be asked to sit in a chair with their back supported and remain relaxed for 10 minutes, allowing the trainer to prepare them for the EEG-NF training. The training will be administered using a 21-channel DC-coupled amplifier produced by BrainMaster Technologies, Inc. The amplifier will be connected to a high-end laptop (G752VS, Intel® Core™ i7-6700HQ CPU @ 2.60GHZ) produced by ASUSTek Computer INC. The Comby EEG lead cap with sensors (Ag/AgCl) of appropriate size will be fixed to the individual’s head, with reference electrodes placed at the mastoids. A sparse amount of EEG gel will be applied to each electrode using a syringe with caution to prevent bridging between adjacent electrodes. The EEG-NF training will be conducted in a large, well-ventilated room. All efforts will be made to maintain the room temperature with a central temperature control system. Participants will be instructed to minimise eyeball movement, head and neck movements, swallowing, and clenching of teeth to minimise motion artifact in the EEG. The BrainMaster Technologies software (BrainAvatar) will provide sound feedback (reward) in real-time when the participant's brain activity meets the desired infraslow (ISF) (0.0–0.1 Hz) threshold at the targeted brain regions. For this study, an ISF EEG-NF program to down-train the bilateral somatosensory cortices (S1) was developed using the BrainAvatar Live standardised low-resolution electromagnetic brain tomography projector software. Standardised low-resolution electromagnetic brain tomography enables selection of brain regions for NF training based on region of interest (ROI) current density and 3D brain mapping using the Montreal Neurological Institute (MNI) coordinates. The BrainAvatar auditory feedback is generated using Musical Instrument Digital Interface (MIDI) tones and sound effects. The auditory feedback serves as a primary reinforcement modality, providing immediate and intuitive cues that reflect real-time brain activity. During EEG-NF training, participants hear auditory cues, such as tones or chimes, that change according to their brain activity relative to predefined training thresholds. When the target brain activity is achieved, rewarding sounds are presented, whereas the absence of these auditory cues indicates that brain activity has moved away from the desired pattern. By continuously linking brain activity with real-time auditory signals, this feedback enables participants to implicitly learn to regulate their brain activity through the principles of operant conditioning. During the EEG-NF training, participants will be instructed to relax, keep their eyes closed, and listen to the auditory feedback. They are not given a prescribed cognitive strategy for producing the auditory feedback, but are simply told that the sound reflects their brain activity and that they should try to change it however they find works. Again, this is consistent with an operant conditioning model of EEG-NF, in which behaviour is shaped by the auditory feedback rather than by explicit instruction. The "training" is the repeated exposure to this feedback loop over multiple sessions, not a set of prescribed cognitive exercises. Please note that all participants will also attend a baseline assessment session (week 0) and a post-intervention assessment session (week 5), each lasting approximately 1.5-2 hours. These assessments will include completing questionnaires for secondary outcome measures, performing a 10-minute resting-state EEG recording, undergoing quantitative sensory testing, and performing simple physical function tests. The questionnaires include information about participant demographics (age, gender, education, ethnicity, well-being), pain (location, nature, intensity, function, thoughts about pain and coping strategies), effects on daily life, current medication history (including pain relief), sleep, psychological states, social support, and the presence of other health issues, if any. There will also be an opportunity to provide thoughts on the treatment during the post-intervention assessment. The trainer is a PhD student trained in EEG-NF and experienced in EEG.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
The eligibility criteria were informed by the most recent PFP consensus statement and relevant literature.. Participants with PFP will be adults aged 18-75 years who report knee pain persisting for more than 3 months, rate their pain as greater than or equal to 4 on an 11-point numerical rating scale, and score less than or equal to 85 on the Anterior Knee Pain Scale (AKPS).
Exclusion criteria
Potential participants will be excluded from the study if they report any other chronic pain condition, current pain or injury affecting the back, hip, or ankle, any neurological condition likely to affect movement, previous knee surgery (in the last 6 months), previous neurofeedback training or current use of oral steroids. They will also be excluded if they have any neurological conditions (e.g. stroke), major psychiatric illness, cognitive impairment, have had former neurosurgical procedures of the brain, are unable to walk without an assistive device, are currently pregnant or post-partum (up to 12 months), systemic inflammatory conditions (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis), cardiac disease, peripheral arterial disease in the lower limb, or uncontrolled hypertension (greater than or equal to 150/95). Please note that pregnant women and individuals up to 12 months post-partum are excluded due to the substantial neuroendocrine and physiological changes associated with pregnancy and the post-partum period, which can influence cortical excitability, EEG activity, and mood regulation. As this study includes EEG-based outcomes, these pregnancy- and post-partum-related changes may introduce additional variability unrelated to the intervention and could confound interpretation of the study findings.
Outcome results
None listed