The Effectiveness of Neurofeedback for the Treatment of Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2020-10-05

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

A number of the studies include double-blind neurofeedback, where half of the participants receive sham neurofeedback, and half receive actual neurofeedback from a region thought to increase pain resilience. The experimenter, participant, and care provider will all be blinded as to which condition the participant is in until the participant leaves the study.

Study Groups

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real neurofeedback

Participants receive neurofeedback from a region of the brain thought to be associated with increasing pain resilience

Group Type ACTIVE_COMPARATOR

Neurofeedback

Intervention Type OTHER

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 neurofeedback

Participants receive neurofeedback from a region of the brain thought to be unrelated with increasing pain resilience

Group Type SHAM_COMPARATOR

Neurofeedback

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes