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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02903303
• Other study ID #: 2016-00236
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: September 1, 2016

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Centre d'antalgie, Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1st encounter with the co-investigator (day 0)
Primary	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)
Primary	Change in neuropathic characteristics of the lumbar pain	Neuropathic characteristics (yes/no) : burning; painful cold; electricity sensation; swarming; tingle; itching; numbness	1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
Primary	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	1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
Primary	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)
Primary	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	1st and 3rd encounters with the co-investigator (day 0, day 28-49)
Primary	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).	1st encounter (day 0)
Primary	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	3rd encounter (day 28-49)
Primary	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)	1st encounter (day 0)
Primary	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)	3rd encounter (day 28-40)
Primary	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 ?	1st encounter (day 0)
Primary	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 ?	3rd encounter (day 28-49)
Secondary	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.	2nd and 3rd encounters (day 14-21, day 24-49)