Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain

NCT ID: NCT02903303

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2016-09-01

Brief Summary

This pilot study consists in testing the efficacy of hypnosis as an adjuvant treatment for patients suffering from chronic lumbar pain and for whom a facet block is indicated by a doctor in the Centre d'antalgie of CHUV (Centre Hospitalier Universitaire Vaudois), where this study will take place. 5 to 8 patients will be included in this study. The goals of this study are :

• Assess the feasibility of such a protocol with more patients
• Measure the number of patients necessary to obtain a significant result
• Search for possible side effects of the combination of both treatments

Every patient in this pilot study will undergo 4 hypnosis sessions within 2 weeks before the facet block. These sessions will be done with an hypnotherapist formed for this kind of treatment.

Three times during this study, each patient will have a discussion with the co-investigator :¨

• 1st discussion : just before the first hypnosis session
• 2nd discussion : after the 4 hypnosis sessions and just before the facet block, approximately 3 to 4 weeks after the 1st discussion
• 3rd discussion : 2 to 4 weeks after the facet block

They will allow to obtain several data :

• Pain assessment : intensity, localization, variability, characteristics, effects on daily life activities
• Anxiety and depression assessment
• Expectations assessment : about both treatments and their combination
• Efficacy assessment : about both treatments for the patient
• Questions about the perceptions of the treatments (prejudice, ...) et possible side effects.

These data will then be analysed (quantitative and qualitative analysis, depending on the question type) to fulfill the objectives of the study.

will include 5 to 8 people suffering from chronic lumbar pain. The procedure consists in two steps :

1. 4 hypnosis sessions as an adjuvant treatment for number 2

2. a facet block, which is the standard procedure in the Centre d'antalgie in CHUV.

There will be no control group, so every patient will participate to the hypnosis sessions and undergo the facet block. All the procedure of the facet block (including contraindications and side effects) are not considered to be part of this study because all patients in this study would have had a facet block if they would not participate in it.

The only data that will be collected are questionnaires about several items (pain, anxiety, depression, ...). These questionnaires are filled with the patient at the beginning of the study (day 0), before the facet block (between day 14 and day 21) and 2-4 weeks after it (between day 28 and day 49). There are quantitative and qualitative questions.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

There will be only one arm for this pilot study. All participants will follow 4 hypnosis sessions, and then the facet block.

Group Type: OTHER

Hypnosis

Intervention Type: OTHER

It will consist in 4 hypnosis sessions within 2 weeks mainly for analgesic purpose. The main themes are :

• 1st session : contact with the therapist, body scan, basic suggestions
• 2nd session : hypnosis induction followed by suggestions tu build a safe place
• 3rd session : it is the first complete hypnosis session (induction and specific suggestions against pain)
• 4th session : very similar to the previous session for the content, focused on auto-hypnosis learning.

Interventions

Hypnosis

It will consist in 4 hypnosis sessions within 2 weeks mainly for analgesic purpose. The main themes are :

• 1st session : contact with the therapist, body scan, basic suggestions
• 2nd session : hypnosis induction followed by suggestions tu build a safe place
• 3rd session : it is the first complete hypnosis session (induction and specific suggestions against pain)
• 4th session : very similar to the previous session for the content, focused on auto-hypnosis learning.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed consent and signature of the declaration of consent ;
• Patient suffering from chronic lumbar pain (> 3 months)
• Indication for a facet block ;
• Good ability to speak and understand French.

Exclusion Criteria

• Previous facet block for the same indication ;
• Unability to understand or speak French ;
• Unability to understand the written or oral instructions necessary to the protocol application ;
• Acute or severe psychiatric decompensation and/or acute psychosocial distress ;
• Complex psychosocial situation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Marc R Suter

PD Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Suter, Doctor, PD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Centre d'antalgie, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

2016-00236

Identifier Type: -

Identifier Source: org_study_id