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Completed

NCT Number: NCT04259203

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chronic Pain Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pain Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Cote de Nacre, Caen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erickson hypnosis

Behavioral

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

Primary outcomes

  1. Change of the intensity of pain perception

    Time frame: At 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 outcomes

  1. Change of the score at the Brief Pain Inventory

    Time frame: At 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.

  2. Change of the score at the McGill Pain Questionnaire

    Time frame: At 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.

  3. Change of the score at the Beck Depression Inventory

    Time frame: At 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.

  4. Change of the score at the Fatigue Severity Scale

    Time frame: At 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.

  5. Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8)

    Time frame: 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.

  6. Change of the score at the Scale for Outcomes at Parkinson's Disease (SCOPA-PS)

    Time frame: 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.

  7. Change of the score at the Euroqol 5 dimensions 5 levels (EQ-5D-5L)

    Time frame: 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.

  8. Change in the dose of analgesic treatments

    Time frame: At 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.

  9. Change in the dose of psychotropic medications

    Time frame: At 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.

  10. Change of the score at MDS-UPDRS

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • France Parkinson Association

Registry information

Acronym: DOLHYP-PARK-1

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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