Clinical trial NCT02903303: 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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 :

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.


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.

Primary outcomes:
measure: Daily pain history
timeFrame: 1st encounter with the co-investigator (day 0)
measure: Change in pain localization
timeFrame: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
measure: Change in neuropathic characteristics of the lumbar pain
timeFrame: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
measure: Change in lumbar pain intensity
timeFrame: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
measure: Change in lumbar pain interferences
timeFrame: 1st, 2nd and 3rd encounters with the co-investigator (day 0, day 14-21, day 28-49)
measure: Change in Anxiety and Depression assessment
timeFrame: 1st and 3rd encounters with the co-investigator (day 0, day 28-49)
measure: Presumed efficacy and expectations about treatments of lumbar pain
timeFrame: 1st encounter (day 0)
measure: Efficacy about treatments of lumbar pain
timeFrame: 3rd encounter (day 28-49)
measure: Functionality enhancement expectations thanks to hypnosis
timeFrame: 1st encounter (day 0)
measure: Functionality enhancement thanks to hypnosis
timeFrame: 3rd encounter (day 28-40)
measure: Questions with a qualitative analysis (part 1)
timeFrame: 1st encounter (day 0)
measure: Questions with a qualitative analysis (part 2)
timeFrame: 3rd encounter (day 28-49)
Secondary outcomes:
measure: Security assessment
timeFrame: 2nd and 3rd encounters (day 14-21, day 24-49)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre d'antalgie, Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Marc Suter, Doctor, PD
role: PRINCIPAL_INVESTIGATOR
References: