Clinical trial NCT04097522: The Effectiveness of Neurofeedback for the Treatment of Chronic Pain
Official title: Neurofeeback for Chronic Pain Project (NFB Project)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: neurofeedback
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: TIYGA Health
First posted: 2019-09-20
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the participants that take part in the neurofeedback procedures will receive sham neurofeedback, whilst the other half will receive neurofeedback from an area the investigators believe to be associated with increasing pain resilience. Participants may or may not receive sham neurofeedback, and will be made aware of this fact.
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of neurofeedback (teaching participants to gain control over their own brainwaves) in chronic pain. The study is made up of four pilot studies. Participants who take part will undergo the cold pressor test, submerging their hand in cold water in order to simulate chronic pain. Brain activity will be measured using electroencephalography (EEG).

Detailed description: Chronic pain is a persisting pain which often exists in the absence of detectable tissue damage. It is also associated with feelings of depression, anxiety, and despair. Current treatments for chronic pain usually involves drug treatments, which often has unwanted side effects.

This study aims to assess the effectiveness of neurofeedback, which refers to teaching participants to gain control over their own brainwaves, as an intervention to treat chronic pain. It is believed that by teaching participants to gain control over a brain signal associated with pain resilience, the participant can reduce some of the negative effects associated with chronic pain.

Participants who take part in this study will have their brain activity recorded using electroencephalography (EEG), and have pain elicited using the cold pressor test (CPT), which involves the participant submerging their wrist in cold water to elicit a chronic pain-like sensation. This is a safe, regularly used method, and the participant is free to remove their hand early if the pain becomes too great.

Some participants who take part will undergo neurofeedback training, which will involve them viewing a signal associated with pain resilience, and learning to increase it over multiple sessions.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent for participation in the study
* Must be aged 40 or older

Exclusion Criteria:

* Current or planned hospitalisation during the period of study.
* Non-English speaking participants
* Participants already involved in clinical trials, if it is not possible to schedule around this
* Unable, in the opinion of the research investigator, to comply or adhere to the requirements of the study.
* Patients with chronic pain in both upper limbs
* History of brain injury, stroke or neurosurgical procedures
* An implanted neurostimulator (e.g., deep brain stimulator)
* Damaged skin tissue on the head, or a skin condition such as severe eczema, or any skin allergies
* Failure of cognitive test (Montreal Cognitive Assessment) will exclude participants from taking part in studies that use neurofeedback procedures
* Some but not all of the study will be unavailable to participants currently undergoing psychotherapy (such as cognitive behavioural therapy).

Primary outcomes:
measure: Changes in pain ratings
timeFrame: Throughout the participant's time in the study, approximately 8-16 weeks. (16 sessions which occur approximately twice per week,depending on participant's availability.).
Secondary outcomes:
measure: Smartphone app measures of changes in of chronic pain-related symptoms
timeFrame: Throughout the participant's time in the study, an average of 12 weeks.
measure: Changes in brain activity caused by neurofeedback procedures
timeFrame: Throughout the participant's time in the study, an average of 12 weeks.
measure: Self-report: participant's own ratings of pain experienced
timeFrame: through study completion, an average of 12 weeks.
measure: Questionnaire: Brief Pain Inventory
timeFrame: through study completion, an average of 12 weeks.
measure: Questionnaire: Participant Demographics
timeFrame: Administered at initial session, one day only
measure: Questionnaire: EQ5D (developed by EuroQol group)
timeFrame: through study completion, an average of 12 weeks.
measure: Questionnaire: Hospital Anxiety and Depression Scale
timeFrame: through study completion, an average of 12 weeks.
measure: Questionnaire: McGill Short Form
timeFrame: through study completion, an average of 12 weeks.
measure: Questionnaire: Medical history
timeFrame: Administered at initial session, one day only
measure: Assessment: Montreal Cognitive Assessment
timeFrame: through study completion, an average of 12 weeks.
measure: Questionnaire: Pain Catastrophizing Scale
timeFrame: through study completion, an average of 12 weeks.
measure: Questionnaire: PANAS (Positive and Negative Affect Schedule)
timeFrame: through study completion, an average of 12 weeks.
measure: Questionnaire: PSEQ (Pain Self-Efficacy Questionnaire)
timeFrame: through study completion, an average of 12 weeks.
measure: Assessment: Tender Points Survey
timeFrame: through study completion, an average of 12 weeks.
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Greater Manchester
Study officials:
References: