Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease (DOLHYP-PARK-1)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Parkinson Disease
• Intervention / Treatment: Behavioral: Erickson hypnosis

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • CHU Côte de Nacre
  • Lille, France, 59800
    • Hopital Roger Salengro, CHRU de Lille
  • Rouen, France
    • Hopital Charles Nicolle Chu Rouen
  • Toulouse, France, 31300
    • Hopital PURPAN CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erickson hypnosis; 5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions.	Behavioral: Erickson hypnosis; 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
No Intervention: Usual care; Usual management of pain symptoms

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: France Parkinson Association
• Investigators: Principal Investigator: Luc Defebvre, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2020
• Primary Completion (Actual): August 16, 2024
• Study Completion (Actual): August 16, 2024

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Estimated): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Hypnosis; Pain perception; No-motor symptoms; Auto-hypnosis
• Additional Relevant MeSH Terms: Synucleinopathies; Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Parkinson Disease
• Other Study ID Numbers: 2018-51; 2019-A00539-48 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No