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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00539-48 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| France Parkinson Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erickson hypnosis | Experimental | 5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions. |
|
| Usual care | No Intervention | Usual management of pain symptoms |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luc Defebvre, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Cote de Nacre | Caen | France | ||||
| Hôpital Roger Salengro, CHRU de Lille |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
| Lille |
| 59800 |
| France |
| Hopital Charles Nicolle Chu Rouen | Rouen | France |
| Hopital Purpan Chu Toulouse | Toulouse | 31300 | France |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |