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

NCT02903303 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-08-23

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Marc Suter, Doctor, PD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2016-09-01
Completion
2016-09-01

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903303 on ClinicalTrials.gov