Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
Primary Purpose
Chronic Pain
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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.
Sites / Locations
- Centre d'antalgie, Centre Hospitalier Universitaire Vaudois
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
There will be only one arm for this pilot study. All participants will follow 4 hypnosis sessions, and then the facet block.
Outcomes
Primary Outcome Measures
Daily pain history
During the first encounter (day 0), we will ask the patient since when he/she suffers from daily pain:
Daily pain in general since : < 3 months ; 3-6 months ; 6-12 months ; 1-3 years ; 3-5 years ; 5-10 years ; 10-20 years ; > 20 years
Daily lumbar pain since : < 6 months ; 6-12 months ; 1-3 years ; > 3 years
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.
Change in neuropathic characteristics of the lumbar pain
Neuropathic characteristics (yes/no) :
burning
painful cold
electricity sensation
swarming
tingle
itching
numbness
Change in lumbar pain intensity
Intensity on a scale from 0 (no pain) to 10 (worst pain imaginable) :
Worst pain during the previous week
Lowest pain during the previous week
Average pain during the previous week
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
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) :
I feel tense and angry
I am afraid, just like if something horrible was going to happen to me
I'm worried
I can sit quietly doing nothing and feel relaxed
I experience feelings of fear and feel my stomach tensed
I have ants in my pants and can't stay in place
I experience sudden feelings of panic
I feel the same pleasure to the same things as before
I easily laugh and see things in a good way
I am in a good mood
I feel like I work slowly
I don't take care about my appearance anymore
I'm looking forward to doing some things
I can enjoy a good book or a good TV/radio show
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)
Hypnosis alone
Facet block alone
Combination of both
On a scale from 0 to 10, the patient assesses the expectations towards 1), 2) and 3).
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 :
Hypnosis alone
Facet block alone
Combination of both
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 :
do sports
practice the professional activity
do your daily activities
enhance your mood
other (free space for the patient to write)
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 :
do sports
practice the professional activity
do your daily activities
enhance your mood
other (same item as in outcome 9)
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 :
How do you think hypnosis work ?
What do you think will happen during hypnosis ?
Does it make you experience any emotions ?
What do you think of hypnosis as a therapeutical approach ?
How do you think facet block works ?
What do you think will happen during this intervention ?
What do you think of facet block as a therapeutical approach ?
What is your position about pain-relief drugs ?
Do you use other approaches against pain ? If yes, which one and what does and doesn't work with you ?
Do you have further comments about both treatments ?
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 :
How do you feel now about hypnosis as a treatment against pain ?
Did your mind change about hypnosis ? If yes, how and in what ?
Now, do you consider using hypnosis and/or self-hypnosis as a new way to deal with your lumbar pain ?
Do you have further comments about the study or the procedure ?
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02903303
First Posted
May 27, 2016
Last Updated
August 17, 2021
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT02903303
Brief Title
Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
Official Title
Pilot Study : Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
end of recruitment period
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 :
4 hypnosis sessions as an adjuvant treatment for number 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
There will be only one arm for this pilot study. All participants will follow 4 hypnosis sessions, and then the facet block.
Intervention Type
Other
Intervention Name(s)
Hypnosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily pain history
Description
During the first encounter (day 0), we will ask the patient since when he/she suffers from daily pain:
Daily pain in general since : < 3 months ; 3-6 months ; 6-12 months ; 1-3 years ; 3-5 years ; 5-10 years ; 10-20 years ; > 20 years
Daily lumbar pain since : < 6 months ; 6-12 months ; 1-3 years ; > 3 years
Time Frame
1st encounter with the co-investigator (day 0)
Title
Change in pain localization
Description
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.
Time Frame
1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
Title
Change in neuropathic characteristics of the lumbar pain
Description
Neuropathic characteristics (yes/no) :
burning
painful cold
electricity sensation
swarming
tingle
itching
numbness
Time Frame
1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
Title
Change in lumbar pain intensity
Description
Intensity on a scale from 0 (no pain) to 10 (worst pain imaginable) :
Worst pain during the previous week
Lowest pain during the previous week
Average pain during the previous week
Time Frame
1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
Title
Change in lumbar pain interferences
Description
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
Time Frame
1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
Title
Change in Anxiety and Depression assessment
Description
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) :
I feel tense and angry
I am afraid, just like if something horrible was going to happen to me
I'm worried
I can sit quietly doing nothing and feel relaxed
I experience feelings of fear and feel my stomach tensed
I have ants in my pants and can't stay in place
I experience sudden feelings of panic
I feel the same pleasure to the same things as before
I easily laugh and see things in a good way
I am in a good mood
I feel like I work slowly
I don't take care about my appearance anymore
I'm looking forward to doing some things
I can enjoy a good book or a good TV/radio show
Time Frame
1st and 3rd encounters with the co-investigator (day 0, day 28-49)
Title
Presumed efficacy and expectations about treatments of lumbar pain
Description
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)
Hypnosis alone
Facet block alone
Combination of both
On a scale from 0 to 10, the patient assesses the expectations towards 1), 2) and 3).
Time Frame
1st encounter (day 0)
Title
Efficacy about treatments of lumbar pain
Description
On a scale from 0 (no efficacy at all) to 10 (completely relieves the pain), the patient assesses the efficacy of :
Hypnosis alone
Facet block alone
Combination of both
Time Frame
3rd encounter (day 28-49)
Title
Functionality enhancement expectations thanks to hypnosis
Description
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 :
do sports
practice the professional activity
do your daily activities
enhance your mood
other (free space for the patient to write)
Time Frame
1st encounter (day 0)
Title
Functionality enhancement thanks to hypnosis
Description
On a scale from 1 (minimal impact) to 5 (maximal enhancement), the patient assesses how much hypnosis has enhanced his/her ability to :
do sports
practice the professional activity
do your daily activities
enhance your mood
other (same item as in outcome 9)
Time Frame
3rd encounter (day 28-40)
Title
Questions with a qualitative analysis (part 1)
Description
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 :
How do you think hypnosis work ?
What do you think will happen during hypnosis ?
Does it make you experience any emotions ?
What do you think of hypnosis as a therapeutical approach ?
How do you think facet block works ?
What do you think will happen during this intervention ?
What do you think of facet block as a therapeutical approach ?
What is your position about pain-relief drugs ?
Do you use other approaches against pain ? If yes, which one and what does and doesn't work with you ?
Do you have further comments about both treatments ?
Time Frame
1st encounter (day 0)
Title
Questions with a qualitative analysis (part 2)
Description
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 :
How do you feel now about hypnosis as a treatment against pain ?
Did your mind change about hypnosis ? If yes, how and in what ?
Now, do you consider using hypnosis and/or self-hypnosis as a new way to deal with your lumbar pain ?
Do you have further comments about the study or the procedure ?
Time Frame
3rd encounter (day 28-49)
Secondary Outcome Measure Information:
Title
Security assessment
Description
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.
Time Frame
2nd and 3rd encounters (day 14-21, day 24-49)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Suter, Doctor, PD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'antalgie, Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
We'll reach out to this number within 24 hrs