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

Not Applicable
Conditions
Parkinson Disease
Chronic Pain
Interventions
Behavioral: Erickson hypnosis
Registration Number
NCT04259203
Lead Sponsor
University Hospital, Lille
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
76
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Erickson hypnosisErickson hypnosis5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions.
Primary Outcome Measures
NameTimeMethod
Change of the intensity of pain perceptionAt baseline and 2 months after

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.

Secondary Outcome Measures
NameTimeMethod
Change of the score at the Scale for Outcomes at Parkinson's Disease (SCOPA-PS)At baseline and 2 months after

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.

Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8)At baseline and 2 months after

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.

Change of the score at the Brief Pain InventoryAt baseline and 2 months after

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.

Change of the score at the McGill Pain QuestionnaireAt baseline and 2 months after

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.

Change of the score at the Beck Depression InventoryAt baseline and 2 months after

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.

Change of the score at the Fatigue Severity ScaleAt baseline and 2 months after

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.

Change of the score at the Euroqol 5 dimensions 5 levels (EQ-5D-5L)At baseline and 2 months after

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.

Change in the dose of analgesic treatmentsAt baseline and 2 months after

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.

Change in the dose of psychotropic medicationsAt baseline and 2 months after

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.

Change of the score at MDS-UPDRSAt baseline and 2 months after

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.

Trial Locations

Locations (4)

Hopital Purpan Chu Toulouse

🇫🇷

Toulouse, France

Chu Cote de Nacre

🇫🇷

Caen, France

Hôpital Roger Salengro, CHRU de Lille

🇫🇷

Lille, France

Hopital Charles Nicolle Chu Rouen

🇫🇷

Rouen, France

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