Clinical trial NCT04259203: Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease
Official title: Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Chronic Pain
Keywords: No-motor symptoms
Pain perception
Quality of life
Hypnosis
Auto-hypnosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: France Parkinson Association
First posted: 2020-02-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of the intensity of pain perception
timeFrame: At baseline and 2 months after
Secondary outcomes:
measure: Change of the score at the Brief Pain Inventory
timeFrame: At baseline and 2 months after
measure: Change of the score at the McGill Pain Questionnaire
timeFrame: At baseline and 2 months after
measure: Change of the score at the Beck Depression Inventory
timeFrame: At baseline and 2 months after
measure: Change of the score at the Fatigue Severity Scale
timeFrame: At baseline and 2 months after
measure: Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8)
timeFrame: At baseline and 2 months after
measure: Change of the score at the Scale for Outcomes at Parkinson's Disease (SCOPA-PS)
timeFrame: At baseline and 2 months after
measure: Change of the score at the Euroqol 5 dimensions 5 levels (EQ-5D-5L)
timeFrame: At baseline and 2 months after
measure: Change in the dose of analgesic treatments
timeFrame: At baseline and 2 months after
measure: Change in the dose of psychotropic medications
timeFrame: At baseline and 2 months after
measure: Change of the score at MDS-UPDRS
timeFrame: At baseline and 2 months after
Other outcomes:
Locations:
city: Caen
country: France
facility: Chu Cote de Nacre
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
city: Rouen
country: France
facility: Hopital Charles Nicolle Chu Rouen
city: Toulouse
country: France
facility: Hopital Purpan Chu Toulouse
Study officials:
affiliation: University Hospital, Lille
name: Luc Defebvre, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: