Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Behavioral: Hypnosis sessions
* Behavioral: Relaxation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: peripheral or central neuropathic pain, probable or definite Diagnostic questionnaire score DN4 ≥ 4/10 Chronic Pain with an average of pain intensity greater than or equal to 4/10 (digital scale) Presence of daily or almost daily pain (i.e. at least 4 days per week) Patient with pre-existing pain for > 6 months Patient > 18 and < 60 years old Patient with a stable analgesic treatment since 15 days before inclusion Patient able to participate to the trial during 33 weeks Patient having a health insurance Written informed consent signed by the patient. Exclusion Criteria: Prior treatment with hypnosis Currently under active psychotherapy (Cognitive-Behavior Therapy, psychoanalysis) Work accident or litigation Drugs abuse or Psychoactive Substance Abuse (DSM-IV) Neuropathic pain associated with progressive disease (MS, HIV, cancer ...) Major depression with ongoing disability or psychosis (DSM IV) Intermittent pain Patient with pre-existing pain for < 6 months Other more severe pain than the pain justifying inclusion Subject unable to understand the trial information provided in the informed consent document Subject under curators or guardianship Severe Handicap or amputation Participation to another study in the same period Deafness Cognitive disorders (dementia, Mild Cognitive Impairment, inability to understand the questionnaires) For patients of the control arm: Treatment by hypnosis and / or relaxation, transcranial magnetic stimulation, or invasive treatments (surgery)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnotic analgesia<br>Hypnosis sessions: Hypnosis will consist of 45 minutes hypnosis session with a trained hypnotherapist | Behavioral: Hypnosis sessions<br>* 1 session per week during 8 weeks<br>|
| Experimental: Relaxation<br>Relaxation group: Relaxation will be conducted in 45 minutes sessions with a trained psychotherapist. | Behavioral: Relaxation group<br>* 1 relaxation session per week during 8 weeks<br>|
| No Intervention: Routine care<br>The patients will receive their usual pain treatments throughout the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic pain, Hypnosis, Relaxation