Status:
COMPLETED
Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
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 pai...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02256371
Start Date
January 1 2015
End Date
June 22 2021
Last Update
July 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, France, 92100