The Effectiveness of Neurofeedback for the Treatment of Chronic Pain

University of Manchester

Status: Unknown

Conditions: Chronic Pain

Treatments: Other: Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04097522

244779

Details and patient eligibility

About

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).

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups

real neurofeedback

Active Comparator group

Description:

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

Treatment:

Other: Neurofeedback

sham neurofeedback

Sham Comparator group

Description:

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

Treatment:

Other: Neurofeedback