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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
1 session per week during 8 weeks
1 relaxation session per week during 8 weeks
Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, France
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).
Time frame: 9 week
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
Time frame: 8 months
Evaluation of the feeling of comfort and relaxation
At the end of each hypnosis or relaxation session, with a scale from 0 to 10.
Time frame: 9 weeks
Affective components of pain
At the end of each visit and 3 and 6 months after the end of the treatment
Time frame: 8 months
Emotional processes and Alexithymia
Time frame: 8 months
Neuropathic symptoms (NPSI)
Time frame: 8 months
Interference with pain (Brief Pain Inventory)
Time frame: 8 months
Quality of life assessment
Time frame: 8 months
Depression and anxiety
Time frame: 8 months
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Emotional distress caused by pain
Time frame: 8 months
Pain catastrophizing
Time frame: 9 months
Pain relief
Time frame: 8 months
Delay of onset of analgesic effects
Time frame: 8 weeks
Percentage of responders
Time frame: 8 months