The Effectiveness of Neurofeedback for the Treatment of Chronic Pain

April 15, 2020 updated by: Anthony Jones, University of Manchester

Neurofeeback for Chronic Pain Project (NFB Project)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: real neurofeedback
Participants receive neurofeedback from a region of the brain thought to be associated with increasing pain resilience
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.
Sham Comparator: sham neurofeedback
Participants receive neurofeedback from a region of the brain thought to be unrelated with increasing pain resilience
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pain ratings
Time Frame: 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.).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smartphone app measures of changes in of chronic pain-related symptoms
Time Frame: Throughout the participant's time in the study, an average of 12 weeks.
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.
Changes in brain activity caused by neurofeedback procedures
Time Frame: Throughout the participant's time in the study, an average of 12 weeks.
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.
Self-report: participant's own ratings of pain experienced
Time Frame: through study completion, an average of 12 weeks.
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.
Questionnaire: Brief Pain Inventory
Time Frame: through study completion, an average of 12 weeks.
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.
Questionnaire: Participant Demographics
Time Frame: Administered at initial session, one day only
General information about participant's age, gender, etc
Administered at initial session, one day only
Questionnaire: EQ5D (developed by EuroQol group)
Time Frame: through study completion, an average of 12 weeks.
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.
Questionnaire: Hospital Anxiety and Depression Scale
Time Frame: through study completion, an average of 12 weeks.
Participant self-reports feelings of anxiety and depression, ticking against responses representing their current feelings.
through study completion, an average of 12 weeks.
Questionnaire: McGill Short Form
Time Frame: through study completion, an average of 12 weeks.
Questionnaire assessing participants current pain level
through study completion, an average of 12 weeks.
Questionnaire: Medical history
Time Frame: Administered at initial session, one day only
Participant notes current medications and previous major operations
Administered at initial session, one day only
Assessment: Montreal Cognitive Assessment
Time Frame: through study completion, an average of 12 weeks.
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.
Questionnaire: Pain Catastrophizing Scale
Time Frame: through study completion, an average of 12 weeks.
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.
Questionnaire: PANAS (Positive and Negative Affect Schedule)
Time Frame: through study completion, an average of 12 weeks.
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.
Questionnaire: PSEQ (Pain Self-Efficacy Questionnaire)
Time Frame: through study completion, an average of 12 weeks.
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.
Assessment: Tender Points Survey
Time Frame: through study completion, an average of 12 weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Collaborators

TIYGA Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Anticipated)

October 5, 2020

Study Completion (Anticipated)

October 5, 2020

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 244779

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

No individually identifiable participant data will be shared outside of the research group, and the University of Manchester (for the purposes of audit).

Non-identifiable (pseudo-anonymised) data will be shared with TIYGA Health through their phone app if participants choose to upload this information, however, no phone location data, names, ore any other personal information will be shared with them. Participants are free to choose not to use the phone app with no penalties for not taking part

IPD Sharing Time Frame

Non-identifiable information will be shared, only when participants choose to share it during the neurofeedback training sessions (8-16 weeks). TIYGA Health will retain the data in line with GDPR (General Data Protection Regulation) requirements for pseudo-anonymised data - retaining data for 5 years before deletion (after last data entry), and may archive accounts if no new data is added for 2 years

IPD Sharing Access Criteria

Please contact us at james.henshaw-2@manchester.ac.uk and we will provide email access to the full DMP (Data Management Plan, available at link below)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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