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

Parkinson Disease Clinical Trial

— DOLHYP-PARK-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04259203
• Other study ID #: 2018-51
• Secondary ID: 2019-A00539-48
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2020
• Est. completion date: August 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: Kathy Dujardin, PhD
• Phone: 0320446751
• Email: kathy.dujardin[@]univ-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
France	Chu Cote de Nacre	Caen
France	Hôpital Roger Salengro, CHRU de Lille	Lille
France	Hopital Charles Nicolle Chu Rouen	Rouen
France	Hopital Purpan Chu Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	France Parkinson Association

Country where clinical trial is conducted

France, 

Outcome

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