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

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis sessions
Relaxation group
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic pain, Hypnosis, Relaxation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Hypnotic analgesia

Relaxation

Routine care

Arm Description

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

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

The patients will receive their usual pain treatments throughout the study

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Evaluation of the feeling of comfort and relaxation
At the end of each hypnosis or relaxation session, with a scale from 0 to 10.
Affective components of pain
At the end of each visit and 3 and 6 months after the end of the treatment
Emotional processes and Alexithymia
Neuropathic symptoms (NPSI)
Interference with pain (Brief Pain Inventory)
Quality of life assessment
Depression and anxiety
Emotional distress caused by pain
Pain catastrophizing
Pain relief
Delay of onset of analgesic effects
Percentage of responders

Full Information

First Posted
October 1, 2014
Last Updated
July 19, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02256371
Brief Title
Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain
Acronym
PSYCNEP
Official Title
Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neuropathic pain, Hypnosis, Relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnotic analgesia
Arm Type
Experimental
Arm Description
Hypnosis sessions: Hypnosis will consist of 45 minutes hypnosis session with a trained hypnotherapist
Arm Title
Relaxation
Arm Type
Experimental
Arm Description
Relaxation group: Relaxation will be conducted in 45 minutes sessions with a trained psychotherapist.
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
The patients will receive their usual pain treatments throughout the study
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis sessions
Intervention Description
1 session per week during 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Relaxation group
Intervention Description
1 relaxation session per week during 8 weeks
Primary Outcome Measure Information:
Title
Weekly mean pain intensity in patients diaries
Description
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).
Time Frame
9 week
Secondary Outcome Measure Information:
Title
Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment
Description
Pain intensity measured at the end of each hypnosis or relaxation session and 3 and 6 months after the end of the treatment
Time Frame
8 months
Title
Evaluation of the feeling of comfort and relaxation
Description
At the end of each hypnosis or relaxation session, with a scale from 0 to 10.
Time Frame
9 weeks
Title
Affective components of pain
Description
At the end of each visit and 3 and 6 months after the end of the treatment
Time Frame
8 months
Title
Emotional processes and Alexithymia
Time Frame
8 months
Title
Neuropathic symptoms (NPSI)
Time Frame
8 months
Title
Interference with pain (Brief Pain Inventory)
Time Frame
8 months
Title
Quality of life assessment
Time Frame
8 months
Title
Depression and anxiety
Time Frame
8 months
Title
Emotional distress caused by pain
Time Frame
8 months
Title
Pain catastrophizing
Time Frame
9 months
Title
Pain relief
Time Frame
8 months
Title
Delay of onset of analgesic effects
Time Frame
8 weeks
Title
Percentage of responders
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine ATTAL, MD, PhD
Organizational Affiliation
Groupe Hospitalier Ambroise Paré
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré
City
Boulogne-Billancourt
State/Province
Hauts-de-Seine
ZIP/Postal Code
92100
Country
France

12. IPD Sharing Statement

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

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