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

Neuropathic Pain Clinical Trial

— PSYCNEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256371
• Other study ID #: P130604
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 22, 2021

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 22, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Behavioral:
• Hypnosis sessions
1 session per week during 8 weeks
• Relaxation group
1 relaxation session per week during 8 weeks

Locations

Country	Name	City	State
France	Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré	Boulogne-Billancourt	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	8 months
Secondary	Evaluation of the feeling of comfort and relaxation	At the end of each hypnosis or relaxation session, with a scale from 0 to 10.	9 weeks
Secondary	Affective components of pain	At the end of each visit and 3 and 6 months after the end of the treatment	8 months
Secondary	Emotional processes and Alexithymia		8 months
Secondary	Neuropathic symptoms (NPSI)		8 months
Secondary	Interference with pain (Brief Pain Inventory)		8 months
Secondary	Quality of life assessment		8 months
Secondary	Depression and anxiety		8 months
Secondary	Emotional distress caused by pain		8 months
Secondary	Pain catastrophizing		9 months
Secondary	Pain relief		8 months
Secondary	Delay of onset of analgesic effects		8 weeks
Secondary	Percentage of responders		8 months