Chronic PainNCT04097522
The Effectiveness of Neurofeedback for the Treatment of Chronic Pain
A study testing Neurofeedback in people with Chronic Pain, run by University of Manchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2018to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give informed consent for participation in the study
- Must be aged 40 or older
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD
James Henshaw, PhD, 0161 206 4528, james.henshaw-2@manchester.ac.uk
Tim Rainey, 0161 206 0205, timothy.rainey@manchester.ac.uk
About this study
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).
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Neurofeedback
- Keywords
- neurofeedback
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| real neurofeedback | Active comparator | Participants receive neurofeedback from a region of the brain thought to be associated with increasing pain resilience Receives: Other: Neurofeedback |
| sham neurofeedback | Sham comparator | Participants receive neurofeedback from a region of the brain thought to be unrelated with increasing pain resilience Receives: Other: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (14)
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.
Measured: Throughout the participant's time in the study, an average of 12 weeks.
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.
Measured: Throughout the participant's time in the study, an average of 12 weeks.
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).
Measured: through study completion, an average of 12 weeks.
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.
Measured: through study completion, an average of 12 weeks.
Questionnaire: Participant Demographics
General information about participant's age, gender, etc
Measured: Administered at initial session, one day only
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
Measured: through study completion, an average of 12 weeks.
Questionnaire: Hospital Anxiety and Depression Scale
Participant self-reports feelings of anxiety and depression, ticking against responses representing their current feelings.
Measured: through study completion, an average of 12 weeks.
Questionnaire: McGill Short Form
Questionnaire assessing participants current pain level
Measured: through study completion, an average of 12 weeks.
Questionnaire: Medical history
Participant notes current medications and previous major operations
Measured: Administered at initial session, one day only
Assessment: Montreal Cognitive Assessment
Used to assess participant's cognitive abilities, several questions are answered verbally or by writing on the form
Measured: through study completion, an average of 12 weeks.
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
Measured: through study completion, an average of 12 weeks.
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
Measured: through study completion, an average of 12 weeks.
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
Measured: through study completion, an average of 12 weeks.
Assessment: Tender Points Survey
Assessor gently but firmly presses a finger against certain pressure points on the participant to asses levels of pain.
Measured: through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start3 Dec 2018
- Primary completion5 Oct 2020 (estimated)
- Study completion5 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- TIYGA Health
- Responsible party
- Principal investigator, Anthony Jones, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097522
- Sponsor's protocol ID
- 244779
- Status last verified
- Apr 2020
- First submitted
- 21 Nov 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeeback for Chronic Pain Project (NFB Project)
- ClinicalTrials.gov ID
- NCT04097522
- Acronym / sponsor ID
- 244779
- Conditions
- Chronic Pain
- Keywords
- neurofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- TIYGA Health
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 5 Oct 2020 (estimated)
- Study completion
- 5 Oct 2020 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| real neurofeedback | Active comparator | Other: NeurofeedbackParticipants receive neurofeedback from a region of the brain thought to be associated with increasing pain resilience |
| sham neurofeedback | Sham comparator | Other: NeurofeedbackParticipants receive neurofeedback from a region of the brain thought to be unrelated with increasing pain resilience |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing and able to give informed consent for participation in the study
- Must be aged 40 or older
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackDuring 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. | Other | real neurofeedback, sham neurofeedback |
Primary outcome
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.
14 secondary outcomes
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.
Changes in brain activity caused by neurofeedback procedures
Time frame: 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.
Questionnaire: Brief Pain Inventory
Time frame: through study completion, an average of 12 weeks.
Questionnaire: Participant Demographics
Time frame: Administered at initial session, one day only
Questionnaire: EQ5D (developed by EuroQol group)
Time frame: through study completion, an average of 12 weeks.
Questionnaire: Hospital Anxiety and Depression Scale
Time frame: through study completion, an average of 12 weeks.
Questionnaire: McGill Short Form
Time frame: through study completion, an average of 12 weeks.
Questionnaire: Medical history
Time frame: Administered at initial session, one day only
Assessment: Montreal Cognitive Assessment
Time frame: through study completion, an average of 12 weeks.
Questionnaire: Pain Catastrophizing Scale
Time frame: 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.
Questionnaire: PSEQ (Pain Self-Efficacy Questionnaire)
Time frame: through study completion, an average of 12 weeks.
Assessment: Tender Points Survey
Time frame: through study completion, an average of 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: Yes. 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
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Chronic Pain, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Henshaw, PhD (0161 206 4528, james.henshaw-2@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.