NCT02256371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

6.5 years

First QC Date

October 1, 2014

Last Update Submit

July 19, 2021

Conditions

Neuropathic Pain

Keywords

Neuropathic painHypnosisRelaxation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment

    8 months

  • Evaluation of the feeling of comfort and relaxation

    9 weeks

  • Affective components of pain

    8 months

  • Emotional processes and Alexithymia

    8 months

  • Neuropathic symptoms (NPSI)

    8 months

  • +8 more secondary outcomes

Study Arms (3)

Hypnotic analgesia

EXPERIMENTAL

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

Behavioral: Hypnosis sessions

Relaxation

EXPERIMENTAL

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

Behavioral: Relaxation group

Routine care

NO INTERVENTION

The patients will receive their usual pain treatments throughout the study

Interventions

Hypnosis sessionsBEHAVIORAL

1 session per week during 8 weeks

Hypnotic analgesia
Relaxation groupBEHAVIORAL

1 relaxation session per week during 8 weeks

Relaxation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 able to participate to the trial during 33 weeks
  • Patient having a health insurance
  • Written informed consent signed by the patient.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boulogne-Billancourt, Hauts-de-Seine, 92100, France

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nadine ATTAL, MD, PhD

    Groupe Hospitalier Ambroise Paré

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 3, 2014

Study Start

January 1, 2015

Primary Completion

June 22, 2021

Study Completion

June 22, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

FR(1)