Beneficial Effects of Self-hypnosis/Self-care for Chronic Pain Patients : a MRI and EEG Study

Chronic Pain Clinical Trial

Official title:

Beneficial Effects of Self-hypnosis/Self-care Learning Program for Chronic Pain Patients : a MRI and EEG Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263324
• Other study ID #: 2017/291
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: February 2020
• Source: University of Liege
• Contact: Audrey Vanhaudenhuyse, PhD
• Phone: +3243668482
• Email: avanhaudenhuyse[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major

• Fluency in French

• Fibromyalgia diagnosis

Exclusion Criteria:

• Neurologic disorder

• Psychiatric disorder

• Drug addiction

• Alcoholism

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Self-hypnosis/self-care
Learning phase of self-hypnosis/self-care.

Locations

Country	Name	City	State
Belgium	Hospital University of Liège	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University of Liege	Fondation Benoit

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)