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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2021
• Main ID: NCT02256371
• Date of registration: 01/10/2014
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Randomized Controlled Study of the Efficacy of Hypnosis Versus Relaxation and Control in Neuropathic Pain PSYCNEP
• Scientific title: Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study
• Date of first enrolment: January 2015
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02256371
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Nadine ATTAL, MD, PhD
• Affiliation: Groupe Hospitalier Ambroise Paré

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neuropathic Pain

Intervention(s)

Behavioral: Relaxation group

Behavioral: Hypnosis sessions

Primary Outcome(s)

Weekly mean pain intensity in patients diaries [Time Frame: 9 week]

Secondary Outcome(s)

Interference with pain (Brief Pain Inventory) [Time Frame: 8 months]

Evaluation of the feeling of comfort and relaxation [Time Frame: 9 weeks]

Quality of life assessment [Time Frame: 8 months]

Depression and anxiety [Time Frame: 8 months]

Pain catastrophizing [Time Frame: 9 months]

Neuropathic symptoms (NPSI) [Time Frame: 8 months]

Pain relief [Time Frame: 8 months]

Affective components of pain [Time Frame: 8 months]

Percentage of responders [Time Frame: 8 months]

Delay of onset of analgesic effects [Time Frame: 8 weeks]

Emotional distress caused by pain [Time Frame: 8 months]

Emotional processes and Alexithymia [Time Frame: 8 months]

Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment [Time Frame: 8 months]

Secondary ID(s)

P130604

Source(s) of Monetary Support

Please refer to primary and secondary sponsors