Clinical trial NCT04263324: Beneficial Effects of Self-hypnosis/Self-care for Chronic Pain Patients : a MRI and EEG Study
Official title: Beneficial Effects of Self-hypnosis/Self-care Learning Program for Chronic Pain Patients : a MRI and EEG Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
fibromyalgia
hypnosis
fMRI
EEG
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Fondation Benoit
First posted: 2020-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patients will have a medical and a psychological consultation and will have to fill-in questionnaires (T0). Then, they will receive a psycho-education training (5 sessions) and will have to complete the same questionnaires (T1). After that, they will again have a medical (pain doctor) and a psychological consultation. Afterwards, the care staff will have a multidisciplinary discussion about their diagnosis. Then functional Magnetic Resonance Imaging (fMRI; 1 hour) and HdEEG (1 hour) data will be acquired in resting state. After that, participants will receive a 7 months (2 hours session a month) learning program of self-hypnosis/self-care animated by a therapist specialized in hypnosis. After the 7 months learning-program they will complete the same questionnaires (T2) and be scanned again by means of fMRI and HdEEG. Patient who do not want to participate to the learning program will not have a treatment but will be scanned in the fMRI and the HdEEG.
Primary purpose: TREATMENT

Brief summary: Chronic pain concerns one in four adults in Belgium. Fibromyalgia is an example of chronic pain and is characterized by diffused and migrant musculo-tendinous pain localized in the limbs and at an axial level. The technological improvement in neuroimaging allowed to improve, at a cerebral level, the identification of the structural and the functional characteristics of this clinical entity. Studies indicated a modification in cerebral morphometry showing an alteration of white and grey matter in the anterior cingulate cortex, orbitofrontal lateral cortex, cerebellum, basal ganglia, insula, secondary somatosensory cortex, thalamus, amygdala, putamen, superior temporal gyrus and periaqueductal grey matter. At a functional level, studies show un alteration in the connectivity of the default mode network, an atrophy of zones implicated in nociception and an increased activation of zone implicated in response to a nociceptive stimulus.

Nowadays, researchers are interested in finding out the beneficial effects of non-pharmacological techniques to improve de well-being of patients with chronic pain. Hypnosis is one of these techniques that has already proven to be successful in decreasing pain and improving global quality of life. Nevertheless, to our knowledge, no study has been conducted to understand the impact of hypnosis upon the cerebral functioning of these patients. Therefore, the aim of this study is to understand the impact of a 6 months self-hypnosis/self-care learning program upon the structural and functional functioning of the brain by means of functional magnetic resonance imagery (fMRI) and electroencephalography (EEG).


Eligibility criteria: Inclusion Criteria:

* Major
* Fluency in French
* Fibromyalgia diagnosis

Exclusion Criteria:

* Neurologic disorder
* Psychiatric disorder
* Drug addiction
* Alcoholism

Primary outcomes:
measure: Change in pain description
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in sleep difficulties
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in anxiety
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in depression
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in pain disability
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in attitudes and beliefs about pain
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in quality of life
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in locus of control
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change of the impact of pain
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in generic health
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in health status
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Change in physical activity
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Motivation to change
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
measure: Impact on return-to-work
timeFrame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Hospital University of Liège
Study officials:
References: