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A randomized double-blind controlled two centers study. The primary objective of this study will be to show a superiority of hypnosis over relaxation on pain intensity in patients with neuropathic pain.
The secondary objectives of this study are:
to show a superiority of hypnosis and relaxation over control group on neuropathic pain.
to show a lasting effect of treatment on neuropathic pain one week after the end of treatment.
to evaluate the clinical predictors of response to hypnosis (nature of neuropathic symptoms, severity of anxiety and depressive symptoms, pain catastrophizing, coping strategies, emotional regulation, response to the first session, positive or negative emotional reaction at the end of hypnosis sessions).
to evaluate the effect of hypnosis at long-term (1, 3 and 6 months after the end of treatment).
to evaluate the effect of hypnosis on emotional processes.
to compare hypnosis to relaxation on short-term effects on pain,
to evaluate the quality of life and the impact of pain on daily life: sleep, mood, anxiety symptoms, analgesics consumption , neuropathic symptoms, affective component of pain and pain catastrophizing.
35 patients will be enrolled in each arm, to obtain 105 in total (3 arms). Total duration for each patient: 8 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnotic analgesia | Experimental | Hypnosis sessions: Hypnosis will consist of 45 minutes hypnosis session with a trained hypnotherapist |
|
| Relaxation | Experimental | Relaxation group: Relaxation will be conducted in 45 minutes sessions with a trained psychotherapist. |
|
| Routine care | No Intervention | The patients will receive their usual pain treatments throughout the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis sessions | Behavioral | 1 session per week during 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly mean pain intensity in patients diaries | The pain intensity score will be recorded daily by each patient on a self-assessment diary using a scale of 0 to 10. The record will begin from the first session of hypnosis or relaxation to the last session (S1 to S9). | 9 week |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment | Pain intensity measured at the end of each hypnosis or relaxation session and 3 and 6 months after the end of the treatment | 8 months |
| Evaluation of the feeling of comfort and relaxation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine ATTAL, MD, PhD | Groupe Hospitalier Ambroise Paré | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré | Boulogne-Billancourt | Hauts-de-Seine | 92100 | France |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| Relaxation group |
| Behavioral |
1 relaxation session per week during 8 weeks |
|
At the end of each hypnosis or relaxation session, with a scale from 0 to 10. |
| 9 weeks |
| Affective components of pain | At the end of each visit and 3 and 6 months after the end of the treatment | 8 months |
| Emotional processes and Alexithymia | 8 months |
| Neuropathic symptoms (NPSI) | 8 months |
| Interference with pain (Brief Pain Inventory) | 8 months |
| Quality of life assessment | 8 months |
| Depression and anxiety | 8 months |
| Emotional distress caused by pain | 8 months |
| Pain catastrophizing | 9 months |
| Pain relief | 8 months |
| Delay of onset of analgesic effects | 8 weeks |
| Percentage of responders | 8 months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |