Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease

Study Overview
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Brief Summary
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This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.

Detailed Description
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A large proportion of patients with Parkinson's disease suffer of chronic pain directly related to the disease. The management of painful symptoms is difficult and currently, there is no commonly admitted guidelines. Several studies have shown the efficacy of Erickson hypnosis to reduce the perception of chronic pain in different conditions. This efficacy has never been tested in Parkinson's disease. The objective of this study is to assess the efficacy of Erickson hypnosis protocol, compared to usual care, for the management of Parkinson's disease-related chronic pain. The study team assume that Erickson hypnosis will be more efficient than usual care to reduce perceived chronic pain. They also assume that regular practice of autohypnosis will contribute to long-term efficacy.

Official Title
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Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease

Conditions
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Parkinson Disease, Chronic Pain

Intervention / Treatment
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* Behavioral: Erickson hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18 to 80 years old idiopathic Parkinson's disease without neurological co-morbidity Suffering from chronic pain (for at least 3 months), related to Parkinson's disease Having a pain intensity of at least 30 mm on the VAS (average intensity over the previous week) for Parkinson's disease-related pain antiparkinsonian, analgesic and psychotropic treatments stable for 1-month having a health insurance signed informed consent form Exclusion Criteria: Patient with a neurological condition other than Parkinson's disease or with an atypical Parkinson's syndrome Early untreated patient Patient with acute intercurrent pain Patient whose pain is mainly attributable to another pathology (rheumatoid arthritis, spondyloarthritis ankylosing, diabetic neuropathy, cancer, etc.) Patient with cognitive impairment objectified by a score at the Montreal Cognitive Assessment (MoCA) <24 Patient with hallucinations and/or psychosis (MDS-UPDRS 1.2> 1) Patient with a apathy (MDS-UPDRS 1.5> 1) Patient with disabling dyskinesia (MDS-UPDRS) 4.1 AND 4.2> 1) Patient under the protection of adults Pregnant or lactating woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erickson hypnosis<br>5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions. | Behavioral: Erickson hypnosis<br>* Erickson hypnosis sessions performed by an experienced hypnotherapist, according to a pre-established protocol : 5 sessions (1 per week). Between each session : exercise of auto-hypnosis by the patient himself, at home<br>|
| No Intervention: Usual care<br>Usual management of pain symptoms | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the intensity of pain perception | Measure of the intensity of pain perception by VAS at the baseline visit and at the post-treatment visit (2 months later). The difference between both values will allow to calculate a variation index. | At baseline and 2 months after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the score at the Brief Pain Inventory | Completion of the Brief Pain Inventory at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index. | At baseline and 2 months after | 
| Change of the score at the McGill Pain Questionnaire | Completion of the McGill Pain Questionnaire at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index. | At baseline and 2 months after | 
| Change of the score at the Beck Depression Inventory | Completion of the Beck Depression Inventory at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index. | At baseline and 2 months after | 
| Change of the score at the Fatigue Severity Scale | Completion of the Fatigue Severity Scale at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index. | At baseline and 2 months after | 
| Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8) | Completion of the PDQ-8 at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index. | At baseline and 2 months after | 
| Change of the score at the Scale for Outcomes at Parkinson's Disease (SCOPA-PS) | Completion of the SCOPA-PS at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index. | At baseline and 2 months after | 
| Change of the score at the Euroqol 5 dimensions 5 levels (EQ-5D-5L) | Completion of the EQ-5D-5L at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index. | At baseline and 2 months after | 
| Change in the dose of analgesic treatments | Analgesic treatments will be recorded during the week preceding each visit and a mean dosage will be calculated during each period. The difference between both mean values will allow to calculate a variation index. | At baseline and 2 months after | 
| Change in the dose of psychotropic medications | Psychotropic medications will be recorded during the week preceding each visit and a mean dosage will be calculated during each period. The difference between both mean values will allow to calculate a variation index. | At baseline and 2 months after | 
| Change of the score at MDS-UPDRS | Completion of the MDS-UPDRS at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index. | At baseline and 2 months after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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No-motor symptoms, Pain perception, Quality of life, Hypnosis, Auto-hypnosis