Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-21 @ 1:33 AM
Study NCT ID:
NCT02903303
Status:
TERMINATED
Last Update Posted:
2021-08-23
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Study Overview
Official Title:
Pilot Study : Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
end of recruitment period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 :ยจ
* 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.
* 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 :ยจ
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: