Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Pain
  • Depression, Anxiety
  • Quality of Life
  • Sleep
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single group assignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

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. T...

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.

Tracking Information

NCT #
NCT04418362
Collaborators
  • East Midlands Spine Ltd
  • PhysioFunction Ltd
Investigators
Principal Investigator: Nicholas Birch East Midlands Spine Ltd