None listed
Conditions
Brief summary
Chronic low back pain (CLBP) is a disabling condition worldwide, associated with huge economic costs. Currently available treatments have a small effect, warranting new targeted treatment approaches. Several studies have demonstrated altered functional connectivity between pain processing brain regions in individuals with CLBP. Neurofeedback is a novel technique that can enable an individual to normalize the brain's electrical activity and functional connectivity through learning, thereby improve pain, function, and associated disability. The proposed double-blinded randomised placebo-controlled pilot study will explore the effect of a novel neurofeedback technique to improve the directional functional connectivity (i.e., effective connectivity) between pain processing brain regions in a specific frequency band in people with CLBP. This pilot study will provide benchmark data and assist in development of a larger trial investigating long-term impact (trajectory profiles) of the proposed intervention on pain and associated disability. The objectives of the proposed pilot study are: • To evaluate the feasibility and safety of the targeted EEG-NF technique training effective connectivity from pgACC to SSC region in individuals with CLBP. • To determine the estimates [central tendency, variability, and confidence intervals] of change in the pain, function, and psychological outcomes following targeted NF training in people with CLBP. • To explore the effect of NF on the effective connectivity from pgACC to SSC region, and • To explore the association between changes in effective connectivity to changes in clinical outcomes (pain, function, and psychological measures).
Interventions
Electroencephalography based (EEG) infraslow frequency (0.01-0.1 Hz) neurofeedback (NF) will be administered three times a week (30 minutes/session) for a total of 4 weeks (i.e., 12 sessions) by the researcher experienced in delivering neuromodulation techniques, using a 21 channel DC coupled amplifier produced by Brainmaster Inc. During each session, participants will be asked to close their eyes and sit relaxed on a chair with back supported. No form of stimulus will be given. The Comby EEG le
Electroencephalography based (EEG) infraslow frequency (0.01-0.1 Hz) neurofeedback (NF) will be administered three times a week (30 minutes/session) for a total of 4 weeks (i.e., 12 sessions) by the researcher experienced in delivering neuromodulation techniques, using a 21 channel DC coupled amplifier produced by Brainmaster Inc. During each session, participants will be asked to close their eyes and sit relaxed on a chair with back supported. No form of stimulus will be given. The Comby EEG lead cap with sensors will be placed on the individual’s scalp. For the active NF treatment group, the Brainmaster Inc. system delivers a sound feedback (reward) each time participant’s effective connectivity between targeted regions in the infraslow band (0.01–0.1 Hz) meets the threshold. The effective connectivity will be trained in the direction of the pregenual anterior cingulate cortex (pgACC) to somatosensory cortex (SSC) in the infraslow frequency (ISF) band. Adherence to the intervention will be measured using the session attendance checklist.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Participants with a diagnosis of chronic low back pain (CLBP) will be eligible to participate. Participants will need to: a) have pain in the lumbar back area that occurs every day for greater than or equal to 3 months, b) have a score of greater than and equal to 4 on the 11-point numeric pain rating scale (NPRS, 0=No pain to 10=Worst pain) in the past 7 days, and c) have a disability score of greater than and equal to 5 on Roland–Morris Disability Questionnaire d) be capable of understanding and signing an informed consent form e) aged between 18 to 70 years on the day of the consent
Exclusion criteria
Participants who meet any of the following conditions will be excluded: • Inflammatory arthritis • Underwent back surgery in the past 6 months • Radicular pain and radiculopathy • Neurological conditions • Cognitive and psychiatric disorders • Epilepsy • Seizures • Substance abuse • Pregnant or six-months post-partum Participants will be permitted to continue their medications for the duration of the trial, with the type and dosage of medication being recorded throughout the duration of the trial. However, participants with the intention of taking new medications in the next three months, will be excluded.
Outcome results
None listed