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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Behavioral: Hypnosis sessions; Behavioral: Relaxation group

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts-de-Seine
    • Boulogne-Billancourt, Hauts-de-Seine, France, 92100
      • Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nadine ATTAL, MD, PhD, Groupe Hospitalier Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: October 1, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 3, 2014

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Neuropathic pain; Hypnosis; Relaxation
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: P130604

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No