Chronic Pain Clinical Trial
Official title:
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).
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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Salford Royal NHS Foundation Trust | Salford | Greater Manchester |
Lead Sponsor | Collaborator |
---|---|
University of Manchester | TIYGA Health |
United Kingdom,
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. |
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