The Effectiveness of Neurofeedback for the Treatment of Chronic Pain

Chronic Pain Clinical Trial

Official title:

Neurofeeback for Chronic Pain Project (NFB Project)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04097522
• Other study ID #: 244779
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: October 5, 2020

Study information

• Verified date: April 2020
• Source: University of Manchester
• Contact: James Henshaw, PhD
• Phone: 0161 206 4528
• Email: james.henshaw-2[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Neurofeedback
During the neurofeedback intervention, participants will be shown visual representations of their own brain activity in real-time. Over a number of sessions participants will teach themselves to increase this brain activity, in order to increase their own pain resilience levels.

Locations

Country	Name	City	State
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	TIYGA Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pain ratings	The investigators will monitor changes in pain ratings, which are ratings of current pain level, given on a scale from 0-10 using a Visual Analogue Scale (VAS). These ratings will be given by participants while undergoing the experimental procedures in the study.	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	Smartphone app measures of changes in of chronic pain-related symptoms	Participants may be given a smartphone app with which to record their current chronic pain levels using sliders. The sliders have no units, sliding towards maximum will indicate high chronic pain, sliding towards minimum indicates low chronic pain. Participants will be free to choose whether to use this or not.	Throughout the participant's time in the study, an average of 12 weeks.
Secondary	Changes in brain activity caused by neurofeedback procedures	The investigators will monitor changes in brain activity associated with neurofeedback procedures, measured using EEG (focusing on the alpha band). It is expected that neurofeedback will cause an increase in brain activity associated with pain resilience.	Throughout the participant's time in the study, an average of 12 weeks.
Secondary	Self-report: participant's own ratings of pain experienced	Participant will self-report on their own levels of pain experienced, using a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain imaginable).	through study completion, an average of 12 weeks.
Secondary	Questionnaire: Brief Pain Inventory	Participant self-assesses current or recent pain using a scale which ranges from from 0 (no pain/does not interfere) to 10 (worst pain imaginable/completely interferes), with high scores representing a worse outcome.	through study completion, an average of 12 weeks.
Secondary	Questionnaire: Participant Demographics	General information about participant's age, gender, etc	Administered at initial session, one day only
Secondary	Questionnaire: EQ5D (developed by EuroQol group)	General measure of overall health, includes a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with 0 representing the worst outcome	through study completion, an average of 12 weeks.
Secondary	Questionnaire: Hospital Anxiety and Depression Scale	Participant self-reports feelings of anxiety and depression, ticking against responses representing their current feelings.	through study completion, an average of 12 weeks.
Secondary	Questionnaire: McGill Short Form	Questionnaire assessing participants current pain level	through study completion, an average of 12 weeks.
Secondary	Questionnaire: Medical history	Participant notes current medications and previous major operations	Administered at initial session, one day only
Secondary	Assessment: Montreal Cognitive Assessment	Used to assess participant's cognitive abilities, several questions are answered verbally or by writing on the form	through study completion, an average of 12 weeks.
Secondary	Questionnaire: Pain Catastrophizing Scale	Measures the extent to which a person 'catastrophises' i.e. overly worries about a pain or events associated with pain, and includes a scale ranging from 0 (Not at all) to 4 (all the time), with high scores for negatively phrased events representing the worst outcomes	through study completion, an average of 12 weeks.
Secondary	Questionnaire: PANAS (Positive and Negative Affect Schedule)	Participant rates a number of words which describe different feelings and emotions, and includes a scale ranging from 1 (Very slightly or not at all) to 5 (Extremely), with high scores for negatively phrased events representing the worst outcomes	through study completion, an average of 12 weeks.
Secondary	Questionnaire: PSEQ (Pain Self-Efficacy Questionnaire)	Participant rates how confident they are that they can do the following things at present, despite their current pain. Scale ranges from 0 (not confident at all) to 6 (completely confident), with a high score indicating confidence in one's own ability to cope or perform a task despite the pain	through study completion, an average of 12 weeks.
Secondary	Assessment: Tender Points Survey	Assessor gently but firmly presses a finger against certain pressure points on the participant to asses levels of pain.	through study completion, an average of 12 weeks.