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

Primary Purpose

Parkinson Disease, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Erickson hypnosis
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring No-motor symptoms, Pain perception, Quality of life, Hypnosis, Auto-hypnosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Cote de Nacre
  • Hôpital Roger Salengro, CHRU de LilleRecruiting
  • Hopital Charles Nicolle Chu RouenRecruiting
  • Hopital Purpan Chu Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Erickson hypnosis

Usual care

Arm Description

5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions.

Usual management of pain symptoms

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 4, 2020
Last Updated
May 17, 2022
Sponsor
University Hospital, Lille
Collaborators
France Parkinson Association
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1. Study Identification

Unique Protocol Identification Number
NCT04259203
Brief Title
Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease
Acronym
DOLHYP-PARK-1
Official Title
Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
France Parkinson Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Chronic Pain
Keywords
No-motor symptoms, Pain perception, Quality of life, Hypnosis, Auto-hypnosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erickson hypnosis
Arm Type
Experimental
Arm Description
5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual management of pain symptoms
Intervention Type
Behavioral
Intervention Name(s)
Erickson hypnosis
Intervention Description
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 Outcome Measure Information:
Title
Change of the intensity of pain perception
Description
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.
Time Frame
At baseline and 2 months after
Secondary Outcome Measure Information:
Title
Change of the score at the Brief Pain Inventory
Description
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.
Time Frame
At baseline and 2 months after
Title
Change of the score at the McGill Pain Questionnaire
Description
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.
Time Frame
At baseline and 2 months after
Title
Change of the score at the Beck Depression Inventory
Description
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.
Time Frame
At baseline and 2 months after
Title
Change of the score at the Fatigue Severity Scale
Description
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.
Time Frame
At baseline and 2 months after
Title
Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8)
Description
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.
Time Frame
At baseline and 2 months after
Title
Change of the score at the Scale for Outcomes at Parkinson's Disease (SCOPA-PS)
Description
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.
Time Frame
At baseline and 2 months after
Title
Change of the score at the Euroqol 5 dimensions 5 levels (EQ-5D-5L)
Description
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.
Time Frame
At baseline and 2 months after
Title
Change in the dose of analgesic treatments
Description
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.
Time Frame
At baseline and 2 months after
Title
Change in the dose of psychotropic medications
Description
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.
Time Frame
At baseline and 2 months after
Title
Change of the score at MDS-UPDRS
Description
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.
Time Frame
At baseline and 2 months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Dujardin, PhD
Phone
0320446751
Ext
+33
Email
kathy.dujardin@univ-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Defebvre, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Cote de Nacre
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Roger Salengro, CHRU de Lille
City
Lille
ZIP/Postal Code
59800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Dujardin, PhD
Phone
0320446751
Ext
+33
Email
kathy.dujardin@univ-lille.fr
First Name & Middle Initial & Last Name & Degree
Luc Defebvre, PhD
Facility Name
Hopital Charles Nicolle Chu Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Purpan Chu Toulouse
City
Toulouse
ZIP/Postal Code
31300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
0567693570

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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