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

NCT ID: NCT02256371

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2021-06-22

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hypnotic analgesia

Hypnosis sessions:

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

Group Type: EXPERIMENTAL

Hypnosis sessions

Intervention Type: BEHAVIORAL

1 session per week during 8 weeks

Relaxation

Relaxation group:

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

Group Type: EXPERIMENTAL

Relaxation group

Intervention Type: BEHAVIORAL

1 relaxation session per week during 8 weeks

Routine care

The patients will receive their usual pain treatments throughout the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hypnosis sessions

1 session per week during 8 weeks

Intervention Type: BEHAVIORAL

Relaxation group

1 relaxation session per week during 8 weeks

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadine ATTAL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Ambroise Paré

Locations

Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré

Boulogne-Billancourt, Hauts-de-Seine, France

Countries

France

Other Identifiers

P130604

Identifier Type: -

Identifier Source: org_study_id