Clinical trial NCT01039727: Prerecorded Autosuggestion in Long-standing Pain Intervention
Official title: Prerecorded Autosuggestion in Long-standing Pain Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Pain [C10.597.617]
Lead sponsor: Free University Medical Center
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The first objective of this thesis is to investigate the hypothesis that prerecorded autosuggestion (PA) can be a theoretically valuable (efficacy) and practical (efficiency) tool in the care of many patients with chronic pain. With a prevalence in chronic pain conditions of +/- 20% of adults, chronic pain is a huge problem for individuals as well as for society, absorbing an enormous amount of resources. Even with all available treatments, many people still suffer from chronic pain, in particular when this pain has a psychosomatic ('functional') origin. In the PALPI study (Prerecorded Autosuggestion in Long-standing Pain Intervention), accompanying this thesis, efforts are made to mainly involve chronic pain of clearly psychosomatic origin.

Detailed description: A number of GPs will be contacted. A working definition of 'chronic pain patient' is put forward. Only patients with chronic pain for which present research suspects a substantial degree of psychosomatic causality are withheld. A randomization of these into three groups is performed by the appropriate department of the VUB. The three groups are: a control group (receiving 'care as usual'), a group receiving additionally to care as usual, 5 autosuggestion CDs (containing +/- 25 different sessions of autosuggestion) and a group receiving additionally to care as usual, email assistance (through a specific internet module), including downloadable CDs as appropriate and access to 'AurelisOnLine' (an internet application with \> 900 different sessions of autosuggestion). Three of the CDs contain pre-recorded sessions of relaxation + autosuggestion aimed at diminishing pain. Other CDs are about relaxation, general wellness, etc. Each arm of investigation contains 30 subjects. Assessments are made at 3 points in time: at the start, at 1 month from the start and at 3 months from the start. The following will be measured: quality of life (through a Dutch version of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)), levels of pain intensity and quality (through a Dutch version of the McGill Pain Questionnaire (SF-MPQ)) and use of painkillers. In addition to this, the acceptance/satisfaction of physicians and patients of this kind of treatment will also be the subject of this investigation.

Eligibility criteria: Inclusion Criteria:

* The subject is aged \> 18 years.
* The subject is a 'chronic pain patient': at least 3 months of almost daily pain.
* The subject has one of the following syndromes and has been sufficiently investigated upon it in order to exclude a physical medical cause:

  * chronic low back pain
  * chronic thoracic pain
  * chronic neck pain
  * fibromyalgia
  * temporomandibular pain dysfunction (TMPD)
  * complex regional pain syndrome (CRPS) = RSD
  * chronic tension-type headache
  * chronic pelvic pain
  * painful bladder syndrome
  * irritable bowel syndrome
  * vulvodynia
* The subject has a fast internet connection with possibility to download and burn CDs and/or copy mp3s on an mp3-player (or knows someone who is willing to take care of this)
* The subject has a CD and/or mp3 player at disposal or will buy one.

As an additional 'inclusion criterion', we explicitly ask the referring physician to include preferably patients whom he would otherwise also advise PALPI.

Primary outcomes:
measure: McGill Pain Questionnaire - Dutch language Version (MPQ-DLV)
timeFrame: 1 month
Secondary outcomes:
measure: Multidimensional Pain Inventory - Dutch language Version (MPI-DLV)
timeFrame: 1 month
measure: Multidimensional Pain Inventory - Dutch language Version (MPI-DLV)
timeFrame: 3 months
measure: McGill Pain Questionnaire - Dutch language Version (MPQ-DLV)
timeFrame: 3 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Free University Brussels
Study officials:
affiliation: Université Libre de Bruxelles
name: Dirk Devroey
role: STUDY_CHAIR
References: