Clinical trial NCT02256371: Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain
Official title: Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Neuropathic pain
Hypnosis
Relaxation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Weekly mean pain intensity in patients diaries
timeFrame: 9 week
Secondary outcomes:
measure: Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment
timeFrame: 8 months
measure: Evaluation of the feeling of comfort and relaxation
timeFrame: 9 weeks
measure: Affective components of pain
timeFrame: 8 months
measure: Emotional processes and Alexithymia
timeFrame: 8 months
measure: Neuropathic symptoms (NPSI)
timeFrame: 8 months
measure: Interference with pain (Brief Pain Inventory)
timeFrame: 8 months
measure: Quality of life assessment
timeFrame: 8 months
measure: Depression and anxiety
timeFrame: 8 months
measure: Emotional distress caused by pain
timeFrame: 8 months
measure: Pain catastrophizing
timeFrame: 9 months
measure: Pain relief
timeFrame: 8 months
measure: Delay of onset of analgesic effects
timeFrame: 8 weeks
measure: Percentage of responders
timeFrame: 8 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré
state: Hauts-de-Seine
Study officials:
affiliation: Groupe Hospitalier Ambroise Paré
name: Nadine ATTAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: