NCT04263324

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

January 2, 2020

Last Update Submit

February 6, 2020

Conditions

Chronic Pain

Keywords

chronic painfibromyalgiahypnosisfMRIEEG

Outcome Measures

Primary Outcomes (14)

  • Change in pain description

    The impact of self-hypnosis/self-care on pain description will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no pain) to 10 (worst pain).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in sleep difficulties

    The impact of self-hypnosis/self-care upon the severity of insomnia will be assessed by means of the "Insomnia Severity Index" (Morin et al., 2001). Scale ranging from 0 (none) to 4 (very severe).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in anxiety

    The impact of self-hypnosis/self-care on anxiety will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in depression

    The impact of self-hypnosis/self-care on depression will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in pain disability

    The impact of self-hypnosis/self-care on pain disability will be assessed by means of the "Pain Disability Index" (PDI, Tait et al., 1990). Scale ranging from 0 (no difficulties) to 10 (a lot of difficulties).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in attitudes and beliefs about pain

    The impact of self-hypnosis/self-care on the attitudes and beliefs about pain will be assessed my means of the "Survey of Pain Attitudes" (SOPA, Jensen \& Karoly, 1987). Scale ranging from 0 (totally wrong) to 10 (totally right).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in quality of life

    The impact of self-hypnosis/self-care on the quality of life will be assessed by means of the "Short Form-36"(SF-36; Ware et al., 1988). Each item is balanced to obtain a score between 0 (worst quality) to 100 (maximum quality).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in locus of control

    The impact of self-hypnosis/self-care on the locus of control will be assessed my means og the "Multidimensional Health Locus of Control" (MHLC, Wallston et al., 1978). Scale ranging from 1 (no agreement) to 4 (agreement).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change of the impact of pain

    The impact of self-hypnosis/self-care on the impact of pain in individual's life, quality of social support and general activity, will be assessed my means of the "Multidimensional Pain Index" (PDI, Kerns et al., 1985). Scale ranging from 0 (none) to 6 (a lot).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in generic health

    The impact of self-hypnosis/self-care on generic health will be assessed by the "EuroQol 5 Dimensions" questionnaire (EQ-5D, Health Policy, 1990). Scale ranging from 1 (no problems) to 3 (extreme problems).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in health status

    The impact of Self-hypnosis/self-care on global health status will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (worst health status) to 100 (best health status).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Change in physical activity

    The impact of self-hypnosis/self-care on the physical activity will be assessed by means of the International Physical Activity Questionnaire (Craig et al., 2003). Participants have to describe the amount of low to intense physical activity they did over a period of 7 days.

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Motivation to change

    The impact of self-hypnosis/self-care on the motivation to change will be assessed by means of the "University of Rhode Island Change Assessment" (URICA, DiClemente et al., 1990). Scale ranging from 1 (no agreement) to 5 (agreement).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

  • Impact on return-to-work

    For participants who continued to work at time of inclusion, the "Work Design Questionnaire" (WDQ, Morgeson \& Hymphrey, 2006) will be administered. Scale ranging from 0 (not at all) to 5 (exactly).

    Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)

Study Arms (2)

Self-hypnosis/self-care group

EXPERIMENTAL

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Behavioral: Self-hypnosis/self-care

Control group

NO INTERVENTION

No intervention

Interventions

Self-hypnosis/self-careBEHAVIORAL

Learning phase of self-hypnosis/self-care.

Self-hypnosis/self-care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major
  • Fluency in French
  • Fibromyalgia diagnosis

You may not qualify if:

  • Neurologic disorder
  • Psychiatric disorder
  • Drug addiction
  • Alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital University of Liège

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

  • Kumar Govindaiah P, Adarsh A, Panda R, Gosseries O, Malaise N, Salamun I, Tshibanda L, Laureys S, Bonhomme V, Faymonville ME, Vanhaudenhuyse A, Bicego A. Exploring Electrophysiological Responses to Hypnosis in Patients with Fibromyalgia. Brain Sci. 2024 Oct 23;14(11):1047. doi: 10.3390/brainsci14111047.

    PMID: 39595811DERIVED

MeSH Terms

Conditions

Chronic PainFibromyalgia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Audrey Vanhaudenhuyse, PhD

CONTACT

+3243668482avanhaudenhuyse@chuliege.be

Aminata Bicego, PhD Student

CONTACT

+3243663499abicego@uliege.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2020

First Posted

February 10, 2020

Study Start

September 1, 2019

Primary Completion

January 31, 2020

Study Completion

March 30, 2020

Last Updated

February 10, 2020

Record last verified: 2020-02

Locations

BE(1)