Chronic PainNCT02903303
Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
A study testing Hypnosis in people with Chronic Pain, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2016to 1 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre d'antalgie, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Pilot Study : Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
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
Read more
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.
- Conditions
- Chronic Pain
- Being tested
- Hypnosis
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | There will be only one arm for this pilot study. All participants will follow 4 hypnosis sessions, and then the facet block. Receives: Other: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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) :
- burning
- painful cold
- electricity sensation
- swarming
- tingle
- itching
- numbness
Measured: 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) :
- Worst pain during the previous week
- Lowest pain during the previous week
- Average pain during the previous week
Measured: 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 :
- General activity B) Mood C) Ability to walk D) Usual work E) Relationship with others F) Sleep G) Taste of living
Measured: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
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
Measured: 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)
- 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).
Measured: 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 :
- Hypnosis alone
- Facet block alone
- Combination of both
Measured: 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 :
- do sports
- practice the professional activity
- do your daily activities
- enhance your mood
- other (free space for the patient to write)
Measured: 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 :
- do sports
- practice the professional activity
- do your daily activities
- enhance your mood
- other (same item as in outcome 9)
Measured: 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 :
- 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 ?
Measured: 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 :
- 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 ?
Measured: 3rd encounter (day 28-49)
Secondary outcomes (1)
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.
Measured: 2nd and 3rd encounters (day 14-21, day 24-49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Why it stopped: end of recruitment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc R Suter, Centre Hospitalier Universitaire Vaudois
- Investigators
- Marc Suter, Doctor, PD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903303
- Sponsor's protocol ID
- 2016-00236
- Other IDs
- 2016
- Status last verified
- Aug 2021
- First submitted
- 27 May 2016
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study : Hypnosis as a Potentiation Technique for the Interventional Treatment of Chronic Lumbar Pain
- ClinicalTrials.gov ID
- NCT02903303
- Acronym / sponsor ID
- 2016-00236
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of recruitment period
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Other: HypnosisThere will be only one arm for this pilot study. All participants will follow 4 hypnosis sessions, and then the facet block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisIt 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. | Other | Treatment |
Primary outcome
Daily pain history
Time frame: 1st encounter with the co-investigator (day 0)
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
Time frame: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
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
Time frame: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
Neuropathic characteristics (yes/no) : * burning * painful cold * electricity sensation * swarming * tingle * itching * numbness
Change in lumbar pain intensity
Time frame: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
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
Time frame: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
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
Time frame: 1st and 3rd encounters with the co-investigator (day 0, day 28-49)
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) : 1. I feel tense and angry 2. I am afraid, just like if something horrible was going to happen to me 3. I'm worried 4. I can sit quietly doing nothing and feel relaxed 5. I experience feelings of fear and feel my stomach tensed 6. I have ants in my pants and can't stay in place 7. I experience sudden feelings of panic 8. I feel the same pleasure to the same things as before 9. I easily laugh and see things in a good way 10. I am in a good mood 11. I feel like I work slowly 12. I don't take care about my appearance anymore 13. I'm looking forward to doing some things 14. I can enjoy a good book or a good TV/radio show
Presumed efficacy and expectations about treatments of lumbar pain
Time frame: 1st encounter (day 0)
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) 1. Hypnosis alone 2. Facet block alone 3. 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
Time frame: 3rd encounter (day 28-49)
On a scale from 0 (no efficacy at all) to 10 (completely relieves the pain), the patient assesses the efficacy of : 1. Hypnosis alone 2. Facet block alone 3. Combination of both
Functionality enhancement expectations thanks to hypnosis
Time frame: 1st encounter (day 0)
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 : 1. do sports 2. practice the professional activity 3. do your daily activities 4. enhance your mood 5. other (free space for the patient to write)
Functionality enhancement thanks to hypnosis
Time frame: 3rd encounter (day 28-40)
On a scale from 1 (minimal impact) to 5 (maximal enhancement), the patient assesses how much hypnosis has enhanced his/her ability to : 1. do sports 2. practice the professional activity 3. do your daily activities 4. enhance your mood 5. other (same item as in outcome 9)
Questions with a qualitative analysis (part 1)
Time frame: 1st encounter (day 0)
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)
Time frame: 3rd encounter (day 28-49)
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 ?
1 secondary outcome
Security assessment
Time frame: 2nd and 3rd encounters (day 14-21, day 24-49)
Results and safety
The study was stopped early (reason given: end of recruitment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Suter, Doctor, PD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Chronic Pain, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: end of recruitment period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily pain history (time frame: 1st encounter with the co-investigator (day 0)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.