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Parkinson DiseaseDOLHYP-PARK-1NCT04259203

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

A study testing Erickson hypnosis in people with Parkinson Disease and Chronic Pain, run by University Hospital, Lille at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease, Chronic Pain
What is being tested?
Erickson hypnosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
4 sitesFrance
Study dates
8 Aug 2020to 16 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • antiparkinsonian, analgesic and psychotropic treatments stable for 1-month
  • having a health insurance
  • signed informed consent form

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Chu Cote de Nacre

    Caen

  • Hôpital Roger Salengro, CHRU de Lille

    Lille, 59800

  • Hopital Charles Nicolle Chu Rouen

    Rouen

  • Hopital Purpan Chu Toulouse

    Toulouse, 31300

Other trials in France

About this study

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.

Read the 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.

Being tested
Erickson hypnosis
Keywords
No-motor symptoms, Pain perception, Quality of life, Hypnosis, Auto-hypnosis
Medical subject headings
Parkinson Disease, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erickson hypnosisBehavioural

    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

Study groups in NCT04259203
Study groupRoleWhat they receive
Erickson hypnosisExperimental5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions.
Receives: Behavioral: Erickson hypnosis
Usual careNo interventionUsual management of pain symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At baseline and 2 months after

Secondary outcomes (10)

  1. 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.

    Measured: At baseline and 2 months after

  2. 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.

    Measured: At baseline and 2 months after

  3. 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.

    Measured: At baseline and 2 months after

  4. 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.

    Measured: At baseline and 2 months after

  5. 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.

    Measured: At baseline and 2 months after

  6. 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.

    Measured: At baseline and 2 months after

  7. 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.

    Measured: At baseline and 2 months after

  8. 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.

    Measured: At baseline and 2 months after

  9. 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.

    Measured: At baseline and 2 months after

  10. 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.

    Measured: At baseline and 2 months after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start8 Aug 2020
  3. Primary completion16 Aug 2024
  4. Study completion16 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04259203
Sponsor's protocol ID
2018-51
Other IDs
2019-A00539-48
Acronym
DOLHYP-PARK-1
Status last verified
May 2022
First submitted
4 Feb 2020
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Erickson hypnosis in people with Parkinson Disease and Chronic Pain, run by University Hospital, Lille at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the intensity of pain perception (time frame: At baseline and 2 months after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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