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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Neuropathic Pain

Treatments: Behavioral: Relaxation group; Behavioral: Hypnosis sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT02256371

P130604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

Hypnotic analgesia

Experimental group

Description:

Hypnosis sessions: Hypnosis will consist of 45 minutes hypnosis session with a trained hypnotherapist

Treatment:

Behavioral: Hypnosis sessions

Relaxation

Experimental group

Description:

Relaxation group: Relaxation will be conducted in 45 minutes sessions with a trained psychotherapist.

Treatment:

Behavioral: Relaxation group

Routine care

No Intervention group

Description:

The patients will receive their usual pain treatments throughout the study