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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 :
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 :¨
They will allow to obtain several data :
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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | There will be only one arm for this pilot study. All participants will follow 4 hypnosis sessions, and then the facet block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis | Other | It will consist in 4 hypnosis sessions within 2 weeks mainly for analgesic purpose. The main themes are :
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily pain history | During the first encounter (day 0), we will ask the patient since when he/she suffers from daily pain:
| 1st encounter with the co-investigator (day 0) |
| Change in pain localization | For this outcome, the patient is asked to say where is the daily pain and to precise if the pain concerns both sides. If there is more than one localization, the patient is asked to say which pain is the worst for him/her. | 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49) |
| Change in neuropathic characteristics of the lumbar pain | Neuropathic characteristics (yes/no) :
| 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49) |
| Change in lumbar pain intensity | Intensity on a scale from 0 (no pain) to 10 (worst pain imaginable) :
| 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49) |
| Change in lumbar pain interferences | For this outcome, we will ask the patient to tell us how much between 0 (no influence at all) and 10 (complete discomfort) the lumbar pain has on : A) General activity B) Mood C) Ability to walk D) Usual work E) Relationship with others F) Sleep G) Taste of living | 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49) |
| Measure | Description | Time Frame |
|---|---|---|
| Security assessment | Immediately after the beginning of the study, every patient will be told to report every adverse effect or discomfort during or after an hypnosis session. During the hypnosis session, the therapist will be vigilant about possible negative effects and will help the patient go through it. He will also make a report about it. Every adverse effect will be discussed in detail with the patient during the 2nd or the 3rd discussion with the co-investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Suter, Doctor, PD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'antalgie, Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
Participant data will remain accessible only for the people working in this study. However, the results will be shown in the context of a master degree in medicine of Mr Florent Schroeter.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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|
| Change in Anxiety and Depression assessment | In this pilot study, we will use the HADS scale (Hospital Anxiety and Depression Scale) to assess the level of anxiety and depression at the beginning of the study (day 0) and at the end of it (day 28-49). The items are the following (on a scale from 0 to 3, depending on the agreement to the sentence) :
| 1st and 3rd encounters with the co-investigator (day 0, day 28-49) |
| Presumed efficacy and expectations about treatments of lumbar pain | On a scale from 0 (no efficacy at all) to 10 (completely relieves the pain), the patient assesses the presumed efficacy in general of : (only for the 1st encounter)
On a scale from 0 to 10, the patient assesses the expectations towards 1), 2) and 3). | 1st encounter (day 0) |
| Efficacy about treatments of lumbar pain | On a scale from 0 (no efficacy at all) to 10 (completely relieves the pain), the patient assesses the efficacy of :
| 3rd encounter (day 28-49) |
| Functionality enhancement expectations thanks to hypnosis | On a scale from 1 (minimal impact) to 5 (maximal enhancement), the patient assesses how much he/she thinks hypnosis will enhance the ability to :
| 1st encounter (day 0) |
| Functionality enhancement thanks to hypnosis | On a scale from 1 (minimal impact) to 5 (maximal enhancement), the patient assesses how much hypnosis has enhanced his/her ability to :
| 3rd encounter (day 28-40) |
| Questions with a qualitative analysis (part 1) | During this encounter, we will ask questions to the patient and write down the main subjects mentioned, so that a theme-based analysis can be done with these. The questions are the following :
| 1st encounter (day 0) |
| Questions with a qualitative analysis (part 2) | During this encounter, we will ask questions to the patient and write down the main subjects mentioned, so that a theme-based analysis can be done with these. The questions are the following :
| 3rd encounter (day 28-49) |
| 2nd and 3rd encounters (day 14-21, day 24-49) |
| D004191 |
| Behavioral Disciplines and Activities |