A mixed methods proof of concept study to ascertain the effectiveness of a home-based self-administered neurofeedback intervention to treat the primary and secondary symptoms of chronic pain.
In order to address the growing problem of chronic pain management in the UK, a proof of concept/feasibility open label study has been devised to test a home-based self-administered non-pharmacological treatment utilising neurofeedback training with a headset and tablet-based software application. This study will include individuals suffering from various types of chronic pain, measuring changes in pain intensity alongside associated symptoms (depression, anxiety, sleep, and quality of life) by utilising a purpose-built software application and headset that is easy to use and structurally robust. Twenty participants will take part in pre-intervention quantitative assessments measuring the primary and secondary symptoms of chronic pain. This will be followed by one-to-one remote training where they will be provided with detailed instructions on how to self-administer the neurofeedback training in the comfort of their own homes. They will then take part in 4-6 training sessions per week over an 8-week period. Post- intervention quantitative assessments will be conducted alongside a qualitative analysis of the experience of doing neurofeedback training for chronic pain. Participant feedback on how the protocol, equipment and research could be improved will also be recorded to inform further research. Participants will also take part in online follow-up assessments at 1, 3, and 6 months after the intervention. Any adjustments to pain medication will also be recorded over this period. It is anticipated this study will provide initial evidence of the safety, efficacy, reliability and validity of a low-cost non-pharmacological solution to the physical, psychological and social difficulties experienced by individuals with chronic pain, with a view to a larger subsequent multisite trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.
East Midlands Spine Ltd
Northampton, United Kingdom
Change in pain intensity as measured by the VNS (Visual Numerical Scale)
Ordinal measurement of individual's pain intensity
Time frame: Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session
Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)
Rating scale (self-administered)
Time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)
A self-report questionnaire assessing sleep quality
Time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Change in quality of life components as measured by the EQ-5D-5L
A self-assessed, health related, quality of life questionnaire.
Time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Changes in EEG activity
Changes in relative Alpha, Theta and Beta ratio, as measured by EEG
Time frame: Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks
Experience of chronic pain and neurofeedback training
Qualitative interviews of the lived experience of taking part in neurofeedback training for chronic pain
Time frame: Post-intervention - after final training session (8 weeks)
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