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Completed

NCT Number: NCT02256371

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hypnosis sessions

Behavioral

1 session per week during 8 weeks

Relaxation group

Behavioral

1 relaxation session per week during 8 weeks

Primary outcomes

  1. Weekly mean pain intensity in patients diaries

    Time frame: 9 week

    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 outcomes

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

    Time frame: 8 months

    Pain intensity measured at the end of each hypnosis or relaxation session and 3 and 6 months after the end of the treatment

  2. Evaluation of the feeling of comfort and relaxation

    Time frame: 9 weeks

    At the end of each hypnosis or relaxation session, with a scale from 0 to 10.

  3. Affective components of pain

    Time frame: 8 months

    At the end of each visit and 3 and 6 months after the end of the treatment

  4. Emotional processes and Alexithymia

    Time frame: 8 months

  5. Neuropathic symptoms (NPSI)

    Time frame: 8 months

  6. Interference with pain (Brief Pain Inventory)

    Time frame: 8 months

  7. Quality of life assessment

    Time frame: 8 months

  8. Depression and anxiety

    Time frame: 8 months

  9. Emotional distress caused by pain

    Time frame: 8 months

  10. Pain catastrophizing

    Time frame: 9 months

  11. Pain relief

    Time frame: 8 months

  12. Delay of onset of analgesic effects

    Time frame: 8 weeks

  13. Percentage of responders

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PSYCNEP

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2014
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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